PHARMACEUTICAL and BIOTECH

J. Edgar and Associates Inc. is an industry Leader in Scientific, Clinical and Operations Recruitment at all Levels. If you are currently in the Market for a new employment opportunity, we invite you to view the current opportunities below.

Check frequently for the latest hot jobs...Director Product Development...Associate Director Lab Operations...Analytical Development Associate Director...Clinical Data Managers...Manager Clinical Supplies...Director Formulations...Research Scientist...Biostatistics Manager...Senior Manager Analytical Chemistry...Associate Director Analytical Chemistry...Sr. Manager Regulatory Affairs...Sr. Manager Research Scientist...Engineering Manager...


 

DIRECTOR OF PRODUCT DEVELOPMENT, FORMULATIONS AND ANALYTICAL, $140-160K, GTA        

We are currently seeking a capable leader of a development group that consists of Formulations and Analytical development, Process development, Optimization and Scale-up for unique Pharmaceutical products.  The ideal candidate has led and managed development for semi solid products and liquid formulations in all of their iterations: Topical, Oral, Nasal Spray, Parenteral ,Ointments, Gels, Creams.

As leader of both Formulation and Analytical groups, you will provide strategic direction and technical guidance while steering validation and regulatory compliance.

While the scope of responsibilities is comprehensive as Director, you will be tasked with specific responsibilities that will require optimal time management and strong communication capabilities. These mandates are: Build and manage a scientific team and oversee research and development and project management, determine the scope and strategy for R&D projects and allocate work accordingly while providing direction to Scientists, ensuring that the work is complete, correct and on-time, consulting with all internal stakeholders to ensure Product Development project strategy is scientifically sound, technically feasible and will comply with SOP’s and GMP’s prior to committing an approach for completion, provide technical staff with adequate instructions and coaching to ensure the correct execution of assigned tasks, ensure that all regulated activities in the area of responsibility are adequately described in written procedures and protocols and that the work is performed and documented according to the written procedures and the regulations, responsible for determining timelines and negotiating resource requirements with the Formulation and Analytical Development Teams for scheduling of project work, review of the compilation, evaluation, interpretation and reporting of experimental results to ensure the objectives of each project are met, set platform priorities for development in conjunction with operational leadership and help coordinate product development, provide scientific leadership, advice, oversight and coordination in developing the product specifications and generating data for intellectual property collation, manage budget of Product Development group while ensuring all activities are coordinated with Formulation and Analytical Teams, Customer Service, Technical Writing, Purchasing, Data Review, Microbiology and Quality Assurance.

Position Qualifications: M.S. or Ph.D. in pharmaceutical sciences, with at least 10 years of related experience in research and development and expert level knowledge of product and analytical methods development and validation of pharmaceutical products. Working knowledge of current regulatory and pharmacopoeial requirements (USP-ICH) for testing of pharmaceutical materials and products.

Salary : $140-160K Location: GTA - a successful and growing firm just off a major highway.

Call Jason Edgar at 416 225-2628, resumes to: careers@jedgarcareers.com, or Cris Murray at 416 225-6386, resumes to: jedgar@sympatico.ca


ASSOCIATE DIRECTOR LABORATORY OPERATIONS MANAGEMENT TO $130K, GTA 

We are currently seeking a Senior leader in Pharmaceutical Laboratory Operations to manage Teams in charge of testing and ensuring compliant Quality for Raw Materials, Finished Products, Microbiology, Stability and Technical Lab support functions.

The incumbent will oversee the extended Laboratory operations group through a strong line of Supervisors and special Project Managers.  This position will establish the scope, strategy and resource planning requirements to enable smooth and compliant flow of Raw Materials, a structured and cGMP compliant Finished products QC regimen while maintaining and fine-tuning the capex budget and headcount.  Coordination experience with other departments including Customer Service, Supply Chain, Regulatory Affairs, QA and Operations is essential, this is a high paced non-stop production environment. 

The incumbent must be expert in: Regulatory agency readiness and positive outcome Audit proofing. You must be an OOS/OOT and Suspect Results leader, who can direct and advise the team on strategic Investigations' operational and resulting CAPA initiatives using Root Cause analysis.  Solving technical problems to mitigate any impact on the timely delivery of qualified results is an important functional aspect of this role. As AD, you will be Directing and leading Supervisory reports to enable their strong Team leadership in lab operations and the delivery of lab results.

You must have a University degree in Chemistry/ Biochemistry or a similar and applicable related applied Science. It is essential that you are expert in: GMP/cGMP, GLP and USP, BP, EP, NF requirements for testing of pharmaceutical materials and products.  A strong leadership history in Pharmaceutical QC Laboratory operations with excellent communication skills is required.

Location - Toronto - GTA, Salary - $120-130K, Vacation - 3 weeks

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


ANALYTICAL DEVELOPMENT ASSOCIATE DIRECTOR, FDA, HEALTH CANADA, cGMP TO $130K, GTA 

We are currently seeking an Experienced Analytical Development Manager to lead a robust team in Product development, optimization and scale-up.  Your expertise in compliant Method Development, Validation and Transfer, Investigations and troubleshooting is being called upon to lead development of semi solid and liquid formulations.

Your ability to lead Scientists at the bench using the latest Analytical tools and technologies combined with your big picture product development strategy experience is a perfect combination for this role.

The Associate Director is responsible for determining the scope, strategy and timelines for analytical projects and will develop proposals including costing, with internal stakeholders, that meet SOP and cGMP compliance. As Analytical Development leader, you will determine the technical feasibility of prospective analytical methods, procedures and protocols in order to determine accurate costs for quoting.  This position interfaces with internal and external customers on Project updates regularly.

Other responsibilities include: Leading FDA deficiency responses related to AD, Adherence to USP, FDA, ICH, EP, JP, cGXP and cGMP and Pharmacopoeial compliance, workload evaluation of the team, equipment and project requirements, review of the compilation, evaluation, interpretation and reporting of experimental results to ensure the results of each project are met, investigations/failures and deviations and CAPA, testing coordination with other departments - Quality Op's, Data Review, Microbiology and R+D to optimize the delivery of results to customer priorities and expectations, constant review of procedures to optimize cost and process efficiencies.

You must have a Master or PhD in Analytical Chemistry or Pharmaceutical Sciences (or a related Science) plus 7-10 years of experience in Analytical research and development including experience Supervising and/or Managing large technical teams.  Working knowledge of analytical method development and validation compliant to USP and HC pharmacopoeial requirements for the testing of pharmaceutical products and materials is essential experience.

Location - Toronto - GTA, Salary - $120-130K, Vacation - 3 weeks

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


 2 CLINICAL DATA MANAGERS, INTERMEDIATE AND SENIOR TO $95K PLUS 10% BONUS, GTA or Work From Home if you live outside Toronto.

We are seeking 2 CDM's  in total.  The Clinical Data Manager's will lead assigned data management projects by applying project management skills and data management techniques to ensure timely and quality deliverables. The incumbents will manage project timelines and coordinate activities for assigned projects, and be responsible for the development of Data Management Plans, clinical trial case report forms, databases, and overseeing data processing.

A bachelors' degree in health science, registered nurse, or higher equivalent education in relevant disciplines, with a minimum of 2-5 years experience in clinical trial data management, and demonstrated leadership ability to effectively manage clinical trial data management activities and integrate them with the entire clinical trial operations; must communicate effectively, orally and in writing. Experience with clinical trial electronic data capture systems and in particular must have experience using MediData Rave. Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is required. In addition, the incumbent must have excellent oral and written communication skills and to apply such skills in logical and algebraic operations.
 
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our clients winning team as a Clinical Data Manager.

key accountabilities are:  Plan, manage, control and performs data processing and management activities for assigned projects.  These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirements.   Lead assigned data processing and management projects by applying project management skills, data processing and management techniques. Manages timelines and coordinates activities for assigned projects.  Specify database validation checks for assigned studies.  Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules.  Define and monitor clinical trial dataflow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines. Perform clinical trial site monitors’ training on dataflow and quality control processes.  Design and review patient Case Report Forms and database schema.  Test data capture/entry screens.  Accurately and efficiently validate electronically captured data.  Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks.  Lead efforts in building a standard query library for common database modules as well as for therapeutic/drug area specific modules.  Perform quality control procedures on assigned database during the trial, and additional database closure checks at the end of the study.  Train and supervise Data Entry personnel and junior data management personnel on study procedures, study specific handling and management of trial data.  Validate and distribute study progress status reports to internal and external study team members.  Assist in resolving data coding discrepancies resulting from the coding of medical events, treatment procedures and medications.  Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.   Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on trial Case Report Forms (CRFs), database schema and databases for assigned studies.

Salary - $70-$95K plus bonus and full health benefits. Start: ASAP.

Please call Cris Murray 416 225-6386 for all the details.

Please send your resume in confidence to : jedgar@sympatico.ca


MANAGER CLINICAL SUPPLIES/ NEW PRODUCT R+D $170K plus Bonus, USA

We are currently seeking a Manager for Clinical Supply in the early research and development phases of New Drug development.  This position will work closely with Formulations and Materials Management groups, Statisticians, Clinical Research and Data Management teams and other Clinical, Global Drug Safety, Regulatory and Project Management staff to supply Clinical Trial Materials for Clinical Studies.

The Manager will oversee and contribute to the completion of all technical and operational activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources. As Manager, you will deal with complex processes across functions and interact with clinical protocol teams including Biostatisticians and Clinicians, Materials Management, QA, formulation and process development and regulatory affairs groups to provide input into the packaging and labeling strategy.

As Manager, the incumbent will oversee a Team of 5-6 reports tasked with planning, implementing and initiating activities on multiple projects related to the labeling and distribution of clinical supplies to ensure clinical supply study start dates are met. Working closely with Clinical, Formulations and Materials management teams to forecast drug supply needs for clinical studies and Managing labeling contractor activities including Contractor selection is a major aspect of this role. As Manager, you will manage the labeling and distribution budget for each related project and be able to write and review SOPs required for labeling and distribution as well as write and review packaging and labeling batch records and label artwork.

Managing external vendor relationships and negotiating contracts while conducting vendor audits with QA is another aspect of this role. You should be able to perform PPS, IQS, RCVS, EQMS and EBS transactions while preparing and approving purchase orders for specific programs.  This position is tasked with management of Clinical Supply inventory at CMO facilities including movement of Clinical Supplies, monitoring inventory levels, resolving issues and working with QA to resolve quality issues with labeling vendors and clinical supply partners.

You must have BS in Pharmacy or a related Scientific field with a minimum of 6-8 years of relevant experience. You must possess a strong knowledge of the FDA, cGMP and GCP standards as well as Regulatory guidance documents such as Annex 13.

 Salary - $150-170K Bonus - 15-20%, Generous Company Incentives - Executive Class Relocation Program

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


DIRECTOR FORMULATION DEVELOPMENT, PARENTERAL PRODUCTS TO $215 PLUS 25% BONUS

We are currently seeking a senior Drug Formulation and Product development leader. This role will maintain New Development projects from lead optimization to clinical development and through commercialization. We are looking for an Expert with experience and/or knowledge in preformulation, formulation development, and process selection and scale up based on Quality by Design (QbD), oversight of GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs, MAAs).

The qualified candidate will be responsible for lead optimization, API form selection/characterization, preformulation, formulation development, manufacture of clinical supplies, development of efficient and scalable manufacturing processes, process scale up based on Quality by Design (QbD), implementation of innovative technologies, CMO management and global regulatory strategy.

Required Skills: Experienced in formulation and process development and scale-up of parenteral drug products. Expertise in parenteral drug delivery technologies. Knowledge of sustained release parenteral delivery is preferred. Knowledge of basic analytical skills required: HPLC, UV, solid state characterization.  Small Molecule experience is an asset.

Essential Functions: Bring your understanding of the principles and practices of chemistry or pharmaceutical science to integrate and apply this knowledge effectively to formulate new chemical entities.  You will work with scientific senior directors to advance the development of state-of-the-art techniques to characterize substances, assays and tools. As well, you will write technical reports for internal knowledge transfer, meet with research groups for project meetings and prepare data for presentation. In this role you will; conduct data input, analysis, and interpretation while effectively participating in cross-functional team meetings in order to contribute to development plans.  In this position you will Author portions of IND/IMPD submissions, apply formulation development principles and techniques to products and problems and then present the results of your work often interpreting data, and drawing conclusions regarding presented material and the nature of the work. On a regular basis, you will demonstrate your strong abilities in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.

Knowledge, Experience and Skills: 15+ years of experience with PhD in a related scientific discipline: Pharmaceutical Science, Chemical Engineering, Physical Chemical Organic Chemistry.

Salary $200-215K - Bonus - 25% - Vacation - 5 weeks in Total

Relocation - Executive Level complete relocation. Extensive Incentives.

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


RESEARCH SCIENTIST, NEW PRODUCT DEVELOPMENT $175 PLUS 20% 

We are currently seeking an experienced Drug Development Research Scientist for New drug product development from lead (Target)optimization to clinical development and through commercialization. Ideally, we are looking for experience and/or knowledge in preformulation, formulation development, and process selection and scale up based on Quality by Design (QbD), oversight of GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs, MAAs).  The RS will be responsible for API form selection/characterization, preformulation, formulation development, manufacture of clinical supplies, development of efficient and scalable manufacturing processes, process scale up based on Quality by Design (QbD), implementation of innovative technologies, CMO management and global regulatory strategy.  

Bring your experience in formulation and process development and scale-up of parenteral drug products and any expertise in parenteral drug delivery technologies to one of Pharma's most successful R+D teams. Your knowledge of sustained release and extended release in parenteral delivery is key to your success in this role. Your analytical skills in HPLC, UV, solid state characterization will be called upon to advise members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors. 

This position will focus on developing chemical processes for the manufacturing of drug substances. You should be familiar with Pilot Plant operations and be able to write master batch records and safety summaries with limited supervision while paying particular attention to avoiding reactions and processes that do not scale well, such as distilling to dryness and flash chromatography.  As RS, you may suggest alternative chemistry including step optimization and new route selection in order to gain a better understanding of how impurities are formed, tracked and purged throughout the subsequent processing. Collaborating with more senior scientists or scientific directors to advance the development of economical, state-of-the-art techniques to isolate, characterize, purify and mass-produce substance while working on complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity is a regular function in this role.

A PhD in a related scientific discipline: Pharmaceutical Sciences, Chemical Engineering, Physical Organic Chemistry or similar plus 3 years of Industry experience or a MS in similar disciplines with 6 years of experience or more is being requested.

Join one of the most renowned R+D Pharmaceutical development groups in the World.

Salary $130-140K Bonus - 20%  Complete Relocation Package and Incentives

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


BIOSTATISTICS MANAGER SAS/R EXPERT - LEADING GLOBAL R+D FIRM - $160K PLUS 20% BONUS, US WESTCOAST

We are currently seeking a skilled R/SAS expert to lead statistical planning, analysis and reporting for pre-clinical studies across multiple therapeutic  areas. This is an opportunity to join one of the world's most structured R+D drug development teams through Innovation, Collaboration and Dedication. This Biostatistics management (BM) role will impact high level decision making on an impressive and meaningful pipeline.

In this role,  the BM will evaluate experimental design of studies including power analysis and develop statistical plans while selecting appropriate methodologies for research studies in applying statistical theory and analysis methods to data to ensure a solid statistical base for data interpretation. The incumbent must be capable of preparing oral presentations and written reports to share and communicate results with project teams.

A PhD in Biostatistics or a Master's in Biostatistics is required plus ample years of R/SAS experience in the 2-5 years range, enough to warrant complete understanding and expert level hands on experience using these tools. A background in Biology or Bioinformatics would be logical and an asset.

Ideally, we are looking for someone with experience in statistical methodologies used in pre-clinical research using animal model studies or human genetic association analysis, such as mixed effects model, nonparametric methods, survival analysis and generalized linear regression. 

Location - Top 5 rated US City

Salary - $140-160K plus 15%

Relocation - A thorough and generous program - one of the most comprehensive relocations in Pharma.

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


SENIOR MANAGER, ASSOCIATE DIRECTOR ANALYTICAL CHEMISTRY, CLINICAL TO COMMERCIAL, TO $190K, PLUS BONUS 20%

We are currently seeking a strong leader in Analytical Operations with experience supporting the synthesis and development of drug candidates. In this role, the SM will lead a team of 5 tasked with developing and executing analytical and spectroscopic methods to support the characterization of drug substances, synthetic intermediates and drug products.

The Senior Manager will interact closely with other chemists working on drug substance and drug product process development and on the implementation of manufacturing processes.

 Essential Functions

The SM is responsible for directing and executing scientific research for the development of drug candidates or the research support of marketed drugs. In this role, the SM investigates the feasibility of applying advanced principles and techniques of related scientific specialty in regards to products and problems. 

The Senior Manager advances the development of state-of-the-art techniques to characterize substances, assays and tools and supports the plans, designs, implements and analyses laboratory experimentation to advance scientific knowledge of drug substances or drug products.

The SM Directs Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors. You will work on a wide range of problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.

As SM, you will maintain in-depth knowledge of principles and theories, applying such knowledge to the direction that supports Company interests and demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy.

 You must be able to think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills and demonstrate excellent scientific communication skills (both verbal and technical). 

Knowledge, Experience & Skills 5-7 years of experience and PhD in Chemistry, Analytical Chemistry or a related Science. BS or MS degree with extensive industry experience, greater responsibility for cross-department, cross-function or site interactions to develop solutions to issues in drug development in order to contribute scientific knowledge and leadership across functions in the NDA process. This position serves as a resource to management on the scientific strategy and experiment design when necessary and may also serve as an authority for documents used in regulatory filings. Supervisory experience is desired.

 Salary - $170-190K plus 20%, Location, West Coast USA

Relocation - Thorough and Generous; Travel and Tour tickets, packing/shipping, car transport, real estate services, temp housing and much much more.

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


ASSOCIATE DIRECTOR ANALYTICAL CHEMISTRY, COMMERCIAL PRODUCTS TO 190K PLUS BONUS, US WEST COAST

We are currently seeking a Leader in AR+D and Commercial Operations to lead a formidable group of Analytical Chemists.  As Associate Director, your functionality will include: Managing outsourced analytical and quality control testing activities for small molecule APIs and drug products, Serving as the Site Lead for one or more contract testing partners and managing the relationship and activities at a strategic and business level, Establishing priorities and coordinate the testing schedules based on program requirements by interfacing with colleagues in Analytical Operations and counterparts in Chemical Development and Formulation/Process Development, Providing leadership and driving operational excellence in Analytical Operations and at contract partner sites (CMOs and Testing Labs), Providing necessary support during regulatory site inspections or at contract partner sites (CMOs and Testing Labs) for APIs and Commercial drug products.

As Associate Director, Senior Management initiatives are omnipresent - but, not daily. In this role you will take part in: Developing overall strategy and implementing supporting systems for management of outsourced testing needs, considering timelines, risk mitigation and business priorities,  Developing and ensuring compliance to procedures for outsourced testing oversight including  Reviews as well as facilitating approval of proposals, work orders, and changes of scope.  As a member of the Executive Management team you will: Communicate risks and delays to management and technical leads on a timely basis, Support strategic business and quality compliance processes and changes by participating in working groups and acting as a business process owner for system changes as needed.

The incumbent will have some direct experience with the following: Developing effective strategies for the evaluation and selection of contract organizations, Developing metric parameters to evaluate and monitor the performance of contract service providers, Assisting in transfer of new projects to various contract organizations, Coordinating with legal and quality assurance groups to establish confidentiality/nondisclosure agreements, service terms and conditions, and quality agreements.

For this role, you must have a PhD in a related Science, 7-10 years of AR+D with direct hands-on superior Analytical skills(UHPLC GC) in method development, validation and transfer, CMO and Testing Laboratory Outsourcing experience.

Salary - $175-190K plus 20%, Location - West Coast USA, Relocation - Thorough and Generous, Projected Start Date - In place for January 2018, earlier is a Bonus - worthy of a Bonus!

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


 SENIOR MANAGER REGULATORY AFFAIRS, CMC TO $160K, US WEST COAST

We are currently seeking a Senior Manager for Regulatory Affairs responsible for preparing and reviewing technically complex regulatory CMC submissions. This position requires extensive interaction with departments within and outside of Pharmaceutical Development and Manufacturing (PDM) for preparing regulatory documents while meeting aggressive timelines. As Sr. Manager you will ensure regulatory submissions are in line with regulatory requirements and company policies and procedures. Timing is key for these amendments to submissions  using sound scientific justification is employed in CMC regulatory strategy. The Senior Manager will be called upon to provides strategic regulatory advice as appropriate.

Your expertise lies in creating and reviewing change controls and controlled documents to support post-approval changes. The incumbent must ensure that information in the change controls and controlled documents are accurate and scientifically sound.  As Sr. Manager you will manage and deliver change controls to ensure the initiation and implementation of change in a timely and effective manner. 

You must have a BS degree in a relevant discipline and a minimum 8-10 years of relevant experience in Regulatory Affairs. An advanced degree is desirable and an asset.  In this role, it is essential to be a detail-oriented, self-motivated, and organized professional, with excellent verbal and written communication skills and interpersonal skills.

The Senior Manager must have experience with authoring and thoroughly reviewing regulatory/quality CMC documentation for accuracy and conformance to regulatory/quality requirements. Knowledge of regulatory/quality CMC related requirements is a must. You must be able to work independently with minimal direction. Previous people management experience is required. 

Salary - $150-160K plus 18% Bonus, Location - US West Coast, Start - By the end of 2017, Relocation - Thorough and Generous

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


SENIOR MANAGER-RESEARCH SCIENTIST- NDAs -TO $150K PLUS 20% BONUS, US WEST COAST

We are currently seeking an experienced Research Scientist to manage and support methods validation for late stage development and commercial products.  Experience with Methods transfer is essential as this position will be working directly with long distance internal customers, contract manufacturers and external vendors.  The incumbent must be able to manage multiple projects and participate in or lead cross functional project teams.

The role requires expertise in the highest level of analytical support while meeting timelines and ensuring compliance to SOPs, protocols, cGMPs and safety regulations.  The incumbent will support global regulatory filings with methods validation and methods transfer.

In this role, you will direct and execute scientific research for the development of drug candidates or the research support for marketed drugs while investigating the feasibility of applying advanced principles and techniques of related scientific specialty to products and problems.  Your expertise lies in your ability to utilize state- of- the- art techniques to characterize substances, assays and tools.  You must be able to exercise independent judgement in developing methods, techniques and evaluation criteria for obtaining results while being able to recognize anomalous and inconsistent results and interpret experimental outcomes.

In order to achieve success in this role, you should have; a PhD in Chemistry or Equivalent in a related science.  We are looking for someone who has been a lead Investigator on a commercial product ideally or someone who has led a team of Analytical research scientists at different stages of new drug development.  Your ability to manage projects and cross functional team players while overseeing method transfer to contract manufacturers is very important for this role.  You should be expert in LIMS, EmPower, Trackwise, UHPLC and current analytical methods for development and validation.  You must be up to date with USP/ICH/FDA common practices and compliance.

Salary to $150K plus 20% bonus

Relocation is thorough and complete including Temporary housing.

Call Jason Edgar for all the details at 416 225-2628, resumes in Word format careers@jedgarcareers.com


 PROCESS AND MECHANICAL ENGINEERING MANAGER - GMP MANUFACTURING TO 120K, GTA

We are currently seeking an Engineering Manager with at least 7 years of experience and a P.Eng designation to lead the Process and Mechanical aspects of a very productive cGMP environment. This position manages an experienced group of Process Engineers and their Support personnel in resource planning and scheduling for multiple production lines in Pharmaceutical production.   This role will interface with Maintenance, Production Operations, PDS, Commercial and Quality in order to execute equipment, process, product and system's installation, qualification and validation.

Managing and ensuring that all cGMP, Health and Safety, Environment compliance standards are in place and adhered to including up to date processes, SOPs, KPIs, documentation and training are key aspects in this position. As EM, you will also assist in setting engineering project completion dates that align with production, short and long term facility plans and assisting in developing the Engineering capital and operating budget. As EM, you will define, document and implement engineering standards for drawings, specifications, documentation control, software, manuals, test procedures, revision control and configuration.  These items and standards are in place and require update and maintenance as required.

Managing equipment and facility capital projects related to equipment installation or re-location is part of this very focused planning role, this position interfaces with Facilities management regularly. This position oversees the selection, identification and management of contractors and capital projects. This role also works closely with Compliance to provide updates to the Master Validation Plan while overseeing the preparation of protocols/documents for equipment, process and system's qualification/validation.  This position works with Operations Management to lead continuous improvements in terms of design engineering efficiencies, process, quality, safety and problem resolution in compliance with cGMPs. Operational excellence within the Engineering team is a mandate.

You should have at least 7 years of experience in a Pharmaceutical production and Packaging cGMP environment with an Engineering degree in Mechanical or Chemical and a P.Eng designation. You should have a strong understanding of Global Manufacturing Compliance and Technical Standards. Strong MS Project, Visio and AutoCAD skills are essential.

Salary - $110-120K - 3 weeks of  Vacation - Christmas Shut Down - 7 Personal Days

Please call Jason Edgar at 416 225-2628 for all the details. Resumes to - careers@jedgarcareers.com


PRODUCTION MANAGER, PHARMA GMP EXTRACTIONS AND PURIFICATIONS, TO $110K, GTA

We are currently seeking a Production Manager to oversee and manage production of oils and by products using Extraction and Purification processes from plant matter.   It is essential to have previous experience in the realm of Plant oils extraction science. Using extraction technology and organic synthesis, you will lead a team in the production of Oils and Components for Medical therapeutic purposes.

As Production Manager you will: Ensure safety measures are met for facilities and equipment and that staff performs work in accordance with HSE, GMP and SOPs. You will participate in the equipment selection and qualification for the  Production department as per company needs and future organizational planning. You will communicate with and identify vendors for Production related items in compliance with relevant SOPs. You will develop KPIs to measure department performance and implement best practices. You will develop and maintain a Production schedule ensuring timely delivery. You will create or assist in creating and reviewing GMP documentation related to the Production department including SOPs, Master Manufacturing Documents and Process and Equipment SOPs. You will participate in Departmental investigations, CAPAs and suggest new ways to improve systems and processes.

You will manage and mentor a Production team and take ownership of Production methods and processes while maintaining systems and equipment.

You must have a Degree in Chemistry, Chemical Engineering or a related Science plus at least 5 years in a GMP Production environment. Knowledge of related cGMPs, Health Canada Compliance and other applicable regulatory bodies is key for success in this role. Experience Managing and Motivating team members is an important aspect of this role

Knowledge of or designation with ACMPR is important to understand or have.

Please submit your resume Word format to jedgar@sympatico.ca , and call Cris Murray at 416 225-6386.


CLINICAL QC DOCUMENTATION SPECIALIST TO $60K PLUS 10% BONUS, GTA

Our client specializing in Clinical Operations is currently searching for a Clinical Operations QC Documentation and Management Specialist w/ Clinical Trial Master file that will be responsible for performing QC procedures on clinical trial documents and assisting with document assembly, utilizing Clinical Trial Master file.

Duties will be to perform data verification (QC) on statistical programming outputs against data source such as patient case report forms or other information provided.  Electronically assemble and publish Statistical TLGs (tables, listings and graphs).  Perform QC checks on electronically assembled and published documents, such as Clinical Study Reports and other Regulatory submission documents to verify accuracy and completeness of the following elements within the documents: Table of contents, bookmarks and hyperlinks, references, numbers reported in the in-text tables and body text, abbreviation list and others defined by medical writing teams.

Detail oriented, Quality driven, strong verbal and written communication skills required.  Experience with electronic document assembly and publishing is an asset.

Bring your positive ‘can do ‘perspective along and we will get you an interview!

Minimum of 2 years of experience preferably in a Clinical setting utilizing Clinical Trial Master file with a B.Sc. degree.

Start: ASAP

Salary: $60 K plus 10% bonus plus full benefits.

Please call Cris Murray 416 225-6386 for all the details.

Please send your resume in confidence to : jedgar@sympatico.ca


 STATISTICAL PROGRAMMERS, TO $ 140K, NEW JERSEY OR TELECOMMUTE              
Our Client, specializing in Clinical Operations is currently searching for SAS Programmers with 3- 5  years experience in statistical programming, validation, dataset quality control including output tables, listings and graphs. We are seeking candidates with experience in tabulating clinical drug trial study data as well as modelling and analyzing the data. You will also be responsible for the  validation of database logical checks, study specific monitoring reports, developing SAS programming codes generated by other programmers or statisticians independently, generating complete and accurate statistical output reports of the clinical trial data in well-defined formats.

Responsibilities:

  1. Designing specific study data tabulation models, analyzing data models for clinical trials or for integrating clinical trial data from multiple trials such as ISS and ISE datasets. These designs and specifications will be completed according to industry standards using the nomenclature of statistical design of the clinical drug trial sponsor.

  2. Generating complete analysis of data models following the trial sponsors dataset designs and/or specifications.

  3. Performing independent validation of datasets created by other programmers or statisticians.

  4. Developing and testing SAS codes for clinical trial database logical checks and reports.

  5. Documenting data and programming information in compliance with corporate SOPs and guidelines.

  6. Archiving clinical trial data (study data tabulation models and analysis data models) and programming information in accordance with archival SOPs and guidelines.

  7. Developing and providing expertise in other programming and system administration areas as required.

  8. Providing technical guidance and support to less experienced Statistical Programmers.

  9. Contributing to the continuous improvement of the statistical programming processes and procedures and to the establishment of therapeutic area programming standards/conventions/procedures as a lead programmer.

Qualifications and Experience: 

  1. Advanced degree in Computer Science, Mathematics, or Statistics.

  2. M. Sc. with at least 2 - 5 years’ experience (depending on level) in clinical drug trial statistical programming.

  3. Demonstrated leadership ability to effectively manage statistical programming activities and integrate them with the entire clinical trial operation.

  4. Good organizational and time management skills with the ability to manage concurrent projects and adjust to changing priorities.

  5. Detail-oriented, customer and quality-focused.

  6. Excellent interpersonal and teamwork skills.

  7. Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions.

  8. Ability to maintain a high degree of confidentiality with clinical trial data and information.

Salary: US- Sr.$115K-$125K US  Principal $130-$140K US, full benefits, plus 401K, Vacation - 3 weeks

 Location: New Jersey/Telecommute

Please send your resume in confidence to : jedgar@sympatico.ca


INTERMEDIATE, SENIOR  OR PRINCIPAL BIOSTATISTICIAN  WITH MSc. OR Ph.D. TO $125K, TORONTO

Three to four years experience in clinical drug trials (Phase I to Phase IV) or 5 years developing SAS datasets (R is an asset) is required along with the ability to meet with a variety of stakeholders to assess and understand their statistical needs. Above all, an ability to communicate complex details in a concise manner is required.

Your responsibilities include: protocol development, clinical study design, writing ICH reports, medical writing, manuscript preparation, development of statistical analysis plans, consulting in bio-statistics, study design, regulatory issues, interviewing and selecting new biostatisticians as well as SAS programmers and reviewing SOP’s

Educational and Experience:
Ph.D. or MSc. with significant experience in Statistics/Biostatistics
3-5 years experience in clinical drug development in a pharma/biotech, CRO or academic environment
Protocol and Clinical Study design
Clinical data management
SAS programming
Clinical research report writing
Exposure to many therapeutic areas including Cardiovascular, Oncology, Endocrinology and CNS
Experience in the analysis and reporting of Phase I-IV clinical trials
Advanced communication skills written and oral
Excellent interpersonal skills
Flexible and comfortable with tight and changing timelines
Knowledgeable with ICH, FDA, EMEA and TPD guidelines and regulatory issues

Salary - $80-125K plus 10% bonus, 3 week vacation, Toronto 

Please send your resume in confidence to : jedgar@sympatico.ca


 PRINCIPAL OR SENIOR BIOSTATISTICIAN WITH MSc. OR Ph.D. TO $170K, NEW JERSEY OR TELECOMMUTE

Five years experience in clinical drug trials (Phase I to Phase IV) or 5 years developing SAS datasets (R is an asset) is required along with the ability to meet with a variety of stakeholders to assess and understand their statistical needs. Above all, an ability to communicate complex details in a concise manner is required.

Your responsibilities include: protocol development, clinical study design, writing ICH reports, medical writing, manuscript preparation, development of statistical analysis plans, consulting in bio-statistics, study design, regulatory issues, interviewing and selecting new biostatisticians as well as SAS programmers and reviewing SOP’s

Educational and Experience:
Ph.D. or MSc. with significant experience in Statistics/Biostatistics
5 years experience in clinical drug development in a pharma/biotech, CRO or academic environment
Protocol and Clinical Study design
Clinical data management
SAS programming R programming, Matlab, LaTex
Clinical research report writing
Exposure to many therapeutic areas including Cardiovascular, Oncology, Endocrinology, CNS, Women's and Men's Health, ID etc...
Experience in the analysis and reporting of Phase I-IV clinical trials
Advanced communication skills written and oral
Excellent interpersonal skills
Flexible and comfortable with tight and changing timelines
Knowledgeable with ICH, FDA, EMEA and TPD guidelines and regulatory issues

Salary - $155-$170K, 3 week vacation, New Jersey or telecommute

Please send your resume in confidence to : jedgar@sympatico.ca


SENIOR STABILITY MANAGER, STATISTICAL ANALYSIS, PRODUCT TRENDING $165K to $170 PLUS BONUS, WEST COAST USA

We are currently seeking an expert in Product Stability trending using Statistical Analysis to improve and optimize future product batches by revealing production trends.

The main function of this Senior advisory and strategic guidance role is to perform critical and scientifically sound data analysis and interpretation, including statistical analysis for comparability studies, shelf life, degradation rates, trending, specification setting and impact.  This positions works within Product development and manufacturing in an effort to improve product characteristics and shelf life.

In this role you will coordinate timely and 'first time right' delivery of Stability results required by CMC Regulatory groups and for support of Manufacturing and laboratory Investigations.  The incumbent must be able to think critically and creatively and be able to work independently to develop Trending data while developing sound strategies to improve GMP, mitigate and resolve problems that trending has shown.

You should have a Master's or PhD in Statistics or Analytical Chemistry with training and experience using Statistical Analysis tools in Pharmaceutical product trending.  Statistical evaluation of Stability Data experience is required. Experience with Regression Analysis and ANOVA, General linear models and ICH guidelines are essential in this role.

As a sole strategic contributor, this post has no direct reports.  You must have excellent communication skills in order to work with cross functional teams in Regulatory Affairs- CMC, Quality and Production.

Location:  West Coast USA

Salary: $165K - $170K plus 20% Bonus

Relocation: Complete and thorough including temporary housing

Benefits: Complete Health including Fitness, Educational, Research Bursaries for solo R+D initiatives,  

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


ASSOCIATE DIRECTOR STATISTICAL BIOSTATS OPERATIONS, SAS, TO $150K PLUS BONUS, TORONTO

This is a fantastic opportunity to work with an established biostatistics team, assuming  management responsibility for high profile projects. This position is accountable for developing, applying and/or providing expertise in statistical and data management methods and techniques to effectively enable decision making in support of strategies and priorities.

The Associate Director, Statistical Operations will have extensive experience working as a hands on Biostatistician developing clinical trial protocols, writing Statistical Analysis Plans, performing statistical analysis, and generating Statistical and Clinical Study Reports, overseeing the development and implementation of data management and programming work plans and interacting with internal and external clinical trial management personnel.

Additionally, the incumbent will resolve complex problems and provide statistical oversight to other biostatisticians; lead efforts in the development, maintenance and adherence of Corporate policies, SOPs, and therapeutic area specific guidelines; will act as a Lead/Liaison Biostatistician, interacting with clinical trial sponsors and oversee projects in various therapeutic areas.

Qualifications and Experience:

A Ph.D. degree in statistical science or Masters degree,  plus 10 to 15 years of relevant experience is required for this position. For this role you must have strong communication skills as you will be working with cross-functional groups. You must have strong technical competence in SAS programming and Statistical sample size calculation software, statistical validation skills and a thorough understanding of statistical principles and clinical trial methodology. We are looking for someone who has working knowledge of regulatory guidelines relating to statistical analysis, study reports and statistical components of regulatory submissions.

Location:  Toronto, Salary: $120-150K plus Bonus and 4 weeks Vacation

Call Cris Murray at 416 225-6386 for all the details. Resumes in Word format to jedgar@sympatico.ca


SENIOR CLINICAL RESEARCH ASSOCIATE TO $120K, PLUS 10%, FULL BENEFITS, NEW JERSEY, GREATER NEW YORK AREA

Our client, specializing in Clinical operations is searching for a Senior Clinical Research Associate to head up a state of the art Clinical Operations department where you will be responsible for monitoring, reporting, tracking study progress, and assessing compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures. 

The role includes leadership of the Clinical Operations study team as well as assessment and direction of other Clinical Operations staff assigned to studies.  We are looking for an interactive team player who knows how to work with study sponsors, investigational sites and vendors to enable timely and high quality initiations and completions of Clinical Trials.  Our client needs your ability to identify, evaluate and qualify investigators and investigational sites for participation in clinical trials.

Your ability to compile documentation for qualification of clinical sites and ensure they are compliant with ICH-GCP and relevant local regulatory bodies will enable your success in this newly created role.

Bring your keen sense of contract negotiations to collectively participate in and prepare presentations for clinical trials initiation meetings and or training sessions.  Perform on-site monitoring of clinical studies and document monitoring activities through submission of monitoring reports to Clinical Operations management for review.  Responsible for site management.

Requirements: Bachelors degree in Life Sciences or Health related field.  Minimum of 5 years of experience in monitoring clinical trials in the field required.  Excellent written and oral presentation skills, thorough knowledge of GCP's and ability to travel to local study sites.

Salary: $100-120K.

Bonus: full health benefits package.

Please call Cris Murray 416 225-6386 at J. Edgar and Associates Inc. to find out more information about this exciting new opportunity.

Please email your CV in a word format: jedgar@sympatico.ca


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