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...Production Manager...Clinical Data Manager...Clinical QC Documentation..Statistical Programmers...Intermediate or Sr. Biostatistician...Associate Director Analytical Chemistry...Sr. Manager Regulatory Affairs...stay tuned


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 DATA MANAGER TO $90K, PLUS BONUS, Toronto, Great Firm!

The Clinical Data Manager will lead assigned data management projects by applying project management skills and data management techniques to ensure timely and quality deliverables to our clients. The incumbent 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 and performing database quality control procedures.

A bachelors' degree in health science, registered nurse, or higher equivalent education in relevant disciplines, with a minimum of 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.

Salary - $70-90K, Bonus - 10%, Location - GTA

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


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


  MANAGER REGULATORY AFFAIRS CMC TO $140K PLUS 15% BONUS, US WEST COAST

We are currently seeking a 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 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 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 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 7-10 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 RA 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, supervisory or Team Leadership experience is required. 

Salary - $130-140K plus 15% 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 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


MEDICAL AFFAIRS DIRECTOR, GLOBAL PHARMA TO $200K, US EAST COAST                                                                                                                                           

We are currently seeking a capable Medical Scientist (MD or PhD) to lead a Medical Affairs unit of a very successful global pharma.  A background in Neurology or Dermatology is requested for this newly created key management position.  The role will provide clinical and strategic leadership for medical affairs activities including publication strategy, education programs, scientific support for existing products and help the successful launch of newly approved products. This role requires an individual with strong communication skills as well as the ability to build strong relationships with key stakeholders such as commercial and regulatory groups and key opinion leaders. This position will report to the Senior Director/Head Medical Affairs.

As Medical Affairs leader you will: Provide scientific expertise and collaboration within the neurology and dermatology medical R&D and commercial team, Track all manuscript/abstract/poster development and submission as per the medical affairs plan, Contribute to the formation, refinement and execution of medical strategies and tactics for post-hoc analysis for Phase II/III studies under clinical development and for Phase IV study activities, Ensure strategic partnerships with key opinion leaders in neuroscience and dermatology, Contribute and provide expert review of medical content for Medical Science Liaisons, Medical Information and Continuing Medical Education activities, Ensure medical and product information is provided in compliance with SOPs and regulatory requirements.

As a key member of Management you will be asked to: Contribute to the development of scientific advisory board plans that aim to enhance product knowledge and to determine unmet needs. If the incumbent is an MD, they may serve as medical monitor for neurology and/or dermatology clinical studies as well as possible involvement in medical review and approval of promotional materials in compliance with Codes of Practice and FDA regulations.  You may also be asked to participate in clinical due diligence for potential in licensing products for neurology/dermatology franchises and support business development/commercial teams as appropriate.  The travel requirement is 20 – 30%.

Education and Qualifications: MD, PhD; PhD only will be considered for candidates with strong clinical experience, Minimum of 5 years post MD or PhD experience in an academic and/or industry setting, Ideally experienced in medical affairs and publication strategy, Solid understanding of clinical study design methodology and biostatistics, strong passion to drive clinical innovation to improve outcomes for patients, Exceptional communication skills and flexibility to take on new opportunities as they arrive in a growing medical affairs group. You must be capable of maintaining strong relationships with cross-functional stake holders.

Salary - $150-200K plus 15% Bonus, Vacation - 3 weeks to start.

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


   FORMULATION SCIENTIST, SODs, ANDAs TO $100K PLUS BONUS, EAST COAST USA

We are currently seeking a Formulations Scientists to carry out design and development of solid oral dosage forms from ANDA filing through product launch.  The role centers around developing and executing formulation strategies related to product development, e.g. project planning and timelines, experimental design, data evaluation, formulation of relevant and scientifically based conclusions, coordinating studies with other technical groups (Analytical Sciences, Legal, and Regulatory & Pharma Tech). This position maintains a high level of expertise within the field and develops new technologies and concepts to be applied in the development of oral controlled release drug products. The incumbent identifies, analyzes and suggests corrective actions to optimize R&D processes, technology and regulatory compliance issues.

As Formulations Scientist you will be involved in: Design of experiments (DoE) and pre-formulation, formulation development work on Oral Controlled release and immediate release dosage forms, generating and reviewing analytical data to support product development work, In this role, the FS will write protocols and batch records to carry out process development and evaluation work, scale up and pivotal batch manufacturing for Abbreviated New Drug Applications (ANDA’s) submission to regulatory agency including appropriate analytical testing and stability studies on pivotal batches. As FS, you will prepare pharmaceutical product development reports (PDR), Quality overall Summary (QOS) and other necessary documents to support regulatory filing of ANDA’s, planning bioequivalence studies on drug product and evaluating the bioequivalence data to recommend changes in formulation- if needed, carrying out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Experience ensuring compliance with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), all Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) regulations and guidelines are all assets. 

You must have a Bachelor’s Degree, M.Sc., or Ph.D. in Pharmaceutical Sciences or a related field with a minimum of 5-10 years experience in formulation development in either Solid, Semi Solid, Dry powder and/or Liquid Formulation development.  SOD experience is preferred and Generics experience is an asset.

Salary: $90-110K plus 15%, Location: East Coast USA, Start: January - February 2017

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


MANAGER, BIOSTATISTICS, PHARMACEUTICAL , $140 TO $160K PLUS BONUS, PACIFIC USA 

We are currently seeking a Biostatistics Manager for a great firm on the US West Coast.  You must be expert in SAS and/or R and be able to work collaboratively on Phase I to Phase IV Biomedical data with a variety of stakeholders; Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to assess and understand their statistical needs. Above all, an ability to communicate complex details in a concise manner is required.

As Manager, the incumbent will; direct internal and external teams across multi-functional project or functional areas, lead initiatives to gather, organize and analyze data from different sources such as virology, Case Report Forms, and patient tracking.  In this role, you will contribute to the completion of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources.

Educational and Experience:
Ph.D. or MSc. with significant experience in Statistics/Biostatistics for Biomedical data.
3-5 years experience in clinical trial biomedical data development in a pharma/biotech 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  $140-165K, Bonus is 15%, Vacation 3 weeks, Location  California  US West Coast

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


ASSOCIATE DIRECTOR BUSINESS DEVELOPMENT PHARMACEUTICAL COMPONENTS , USA

We are currently seeking an experienced Industrial Pharmaceutical sales expert to deliver huge cost savings to local and international pharmaceutical manufacturing environments.  The incumbent will develop relationships with potential customers in order to drive home the cost savings message. As a purveyor of the most economical pharma component products with the highest Quality standards, this position will bring you large volume high yield contracts.  Your incentive plan will be met, achieved and exceeded.

This position requires strategic Company to Company market intelligence research, isolation of decision makers, presentation and delivery of the high quality, cost savings message.  Your experience in developing and growing B2B industrial pharma component, chemical and active pharmaceutical ingredients  sales is key for this role. This position requires Cost and Costing experience, market research and intelligence capabilities and competitors intelligence and offerings.

Understanding new product developments and how your pharma components can be used in production is key to this role.  This role involves relationship building with existing product lines AND future product developments , so knowing who is doing what at the R+D stage is key.  Other position elements could include; Commercial pricing development, pitching new products to customers, ensuring proper delivery of samples and increasing internal product portfolio using market intelligence.

You  must have a University degree with at least 5 years of proven success in selling Pharmaceutical chemicals, ingredients, components, medical device components or similar.  Proven success in B2B sales is Key.

Location - Continental USA or New Jersey based

Call Jason Edgar at 416 225-2628 for all the details.

Call Jason Edgar for all the details at 416 225-2628, resumes in Word format 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


   DIRECTOR ANALYTICAL DEVELOPMENT AR+D TO $200K, PLUS 20% BONUS, NEW JERSEY

We are currently seeking a leader in Analytical Research and Development for small and large molecule inhalation, transdermal, topical and soft gelatin formulations.  The incumbent will lead analytical research activities and a team of highly skilled senior scientists on a mission to develop ANDA's for the US Market. Product and process development as well as chemistry, manufacturing and controls are key deliverables in this leadership role.  The Director, AR+D will lead a local team and have access to a larger offshore team of scientists and technical specialists to solve problems and assist in method development. This position reports to the Vice President of Research and Development.

As Director and Scientific AR+D leader, in a contributing and supportive role you will; review analytical reports/analytical characterization, method development, release of formulated drug products, drug substance intermediates, starting materials and functional excipients to support generic formulation development at early stages, and subsequently, registration and manufacturing. Developing relationships with partner sites to determine scientific excellence, quality, cost, compliance and timeline will be key to finding success in this role.

This role will work closely with other key stakeholders in Formulation development, Intellectual property, Regulatory affairs and DQA to gain necessary approval as part of the clearance process for timely project progression. Solid understanding of GMP and GLP and current regulatory compliance requirements is essential.  You will oversee both R+D stability programs and Analytical Quality control at partner development sites as necessary. This role holds a place on the Global Manufacturing Senior Management team to assure alignment across the organization, to provide efficient and effective use of stability testing capabilities and to optimize interaction between R+D and commercial operations.

Salary:  $180-200K, Bonus: 20%, Benefits: Full, Relocation if Required: Yes

Qualifications: We are looking for a PhD with 8-10 years of experience in Analytical Chemistry. MS and BS level professional should have 10-15 years of experience.  Previous experience in a wide range of dosage forms is key with some of your experience coming from successful; Inhalation, transdermal, Nasal, topical and soft gelatin product formulations. Your expertise in method development - verification - validation, method transfer, stability programs and testing, inhalation product testing(delivered dose, cascade impactor testing) and regulatory requirements for regulated markets will be called upon regularly.  You should have experience with QbD principles in Analytical R+D.

Call Jason Edgar for all the details at 416 225-2628, Resumes in word format to:   careers@jedgarcareers.com     


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


REGULATORY AFFAIRS MANAGER, PROJECT MANAGER TO $110K, NEW JERSEY, NYC

We are currently seeking a Regulatory Affairs Project Manager for a leading Pharmaceutical firm located in Toronto.  This is a permanent full time position that will handle all Regulatory factors in order for products to gain entry into the US Market.

As a Regulatory Affairs Project  Manager you are responsible for; Preparing and/or reviewing submissions for solid oral dosage forms and liquid dosage forms to the FDA (i.e. NDS/NDA, ANDAs, S/ANDS, CTA, NC, Annual Report, and Cross-Licenses) and/or eCTD's, preparing and/or reviewing responses to deficiency letters (Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes), coordinating the servicing of Notices of Allegations for patents, Reviewing Product Monographs, Package Inserts and Label text, coordinate laboratory analysis as necessary, Reviewing Change Controls and determine filing requirements, Providing regulatory support to internal/external customers, Maintaining current awareness of regulatory guidelines

( ICH, EMEA, FDA, etc.).  This position works as a solo Project Manager reporting to a Global Director, based in the US.

You must have; a University Degree, B.Sc. or higher in Chemistry or Health Sciences,  3-5 years ANDA submissions experience and 5- 10 years of relevant experience in Regulatory Affairs, CMC, Analytical Development or Documentation within the Pharmaceutical industry. Experience is an asset, strong working knowledge of regulatory guidelines, excellent organizational and communication skills (oral and written), the Ability to prioritize many projects and work with deadlines,  Computer Literacy – Microsoft Package including Word, Excel, and Outlook; WordPerfect; Adobe Acrobat; Access Database.

We are looking for a good problem solver with the ability to prepare written responses to deficiency letters from regulatory agencies as this aspect of the work requires the most attention to detail, as well as obtaining approval of changes to approved drug products. 

Salary:  $90-110K, Bonus:  10%, Locations: NJ/NYC, Timeline Immediately.

Call Jason Edgar for all the details at 416 225-2628, Resumes to:   careers@jedgarcareers.com 


REGULATORY AFFAIRS PROJECT LEADER CMC $95K-$105K WITH 12.5 % BONUS,PERM /FT,  MONTREAL, QUEBEC

Our client is currently searching for a Senior Regulatory Affairs Project Leader with expertise in CMC filings and approvals of Canadian Marketed products.   This high profile role reports into the Head of Regulatory Affairs. 

You will be joining an existing team of 15 like minded Regulatory Affairs Professionals charged with contributing to the preparation of pre-submission packages, Responsible for obtaining Chemistry, Manufacturing and Controls (CMC) section of Submissions for New Drug (NDS), Supplemental New Drug (S/NDS), Notifiable Changes (NC) and Clinical Trial Applications (CTA). 

You must be able to provide submission team leadership for all CMC aspects of submissions and other regulatory documents.  Bring your superior communication and documentation specialty skills to the table to help interact with global CMC submission teams for filings and to confirm requirements for submissions for marketed and developed products as well as coordination of filing and approval of Canadian CMC dossiers. 

Your ability to provide CMC advice on patents and participate to Global CMC teams and Task Forces on CMC related topics will get you an in-house interview.    Your previous experience revising and commenting from a CMC perspective on draft HC-ICH, TPD and BGTD policies and guidance will get you a potential job offer.

Past experience Liaising with Canadian Regulatory Authorities is a must.  Overall we are looking for a flexible Regulatory Professional who can work in a fast paced environment with changing priorities and still have the ability to accept the change and help contribute to the overall quality and quantity of all the submissions.  This role requires a Global perspective and the ability to interact with Global Regulatory Affairs with respect and professionalism.  Biologics experience is a serious asset. The ideal candidate must have 5-10 years of CMC experience in an Regulatory Affairs environment preferably in a large Pharmaceutical setting with eCTD’s.

Educational requirements: Bachelors degree or higher in Pharmacy, Chemistry, Regulatory Affairs or related Health Specialty.  French language skills are an asset.

Salary: $95-$105K base, plus 12.5% bonus and 3 weeks vacation plus full benefits.

Start date: December 2016 or January 2017.

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


MANAGER QUALITY CONTROL LABORATORY OPERATIONS TO $90K,  Great firm in the GTA

We are currently seeking a capable QC/Lab Manager  to oversee and manage a QC Testing laboratory for RX and Natural Health products.  The incumbent must be expertly skilled in standard and novel testing methods and techniques such as HPLC, GC, Mass Spectrometry, ICP-MS, UV and Infrared spectrometry.

Experience in Analytical research, method development and validation, transfer and release of pharmaceuticals and NHPs is key.  You should also have experience in the Operations of a testing laboratory from planning projects to training bench analysts to troubleshooting.  Scheduling, budgeting, coaching  and performance review experience are all assets that will help you succeed in this role.

Position functionality includes: Leadership and planning of the QC and R+D laboratory to ensure cGMP regulations, Health Canada and OCS standards, company SOPs, safety standards and all other regulatory requirements. Integrity and Quality maintenance by ensuring all chemical, analytical and microbiological testing is conducted in a timely and compliant manner to ensure testing outcomes data purity.  Developing SOPs, Method Validation Protocols while preparing Certificates of Analysis documentation. Reviewing methods from Analytical Development for implementation into QC while supporting Analysts working with HPLC, GC, GC-MS, ICP-MS and other lab instruments. 

As QC Lab Manager it is important that you have strong hands-on skills in executing methods for the chemical analysis of drug products and raw materials to establish assay, purity and identity of materials. You must also be able to generate functional and technically sound validation reports. The Lab Manager will also ensure department Training records are current and compliant. You will oversee Analysts as well as all lab testing equipment; managing their calibration, service and repair requirements.

You must have a B.Sc. in Chemistry or Biochemistry plus at least ten(10) years of experience as a lab analyst including 2-3 years in a Team lead, Supervisory or Management role.  You will be expert in Regulatory and ICH standards associated with analytical method validation, qualification and stability with strong knowledge of USP, Canadian and European Guidelines...with a larger focus on Canadian regulatory compliance. You must have excellent communications skills, Microsoft office and EDC Systems as well as lab software - Empower.

Location - GTA

Salary - $75-90K

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


SENIOR LABORATORY ANALYST, RX QUALITY CONTROL TO $70K, GREAT FIRM IN THE GTA 

We are currently seeking an experienced QC Lab expert Analyst to deliver efficient and timely analytical testing of routine as well as R+D samples - including Raw Materials, In-Process and Finished products - using instrumentation for most testing and wet chemistry roughly 15% of the time.  Method optimization and method validation expertise would really help in this role as well as expert knowledge of HPLC and GC Operations, their associated software and sample preparation techniques too.

In order to succeed in this role, you will need to have very good Troubleshooting for instrumentation and analytical problem solving skills. Your strong GMP, GLP, SOPs, Health and Safety regulations understanding will help you in this post.  Your ability to plan, prioritize and complete multiple projects in tandem is key. Experience with Laboratory non conformance investigations as well as reporting data in accordance with GMP regulations and SOP compliance is required.

You must have excellent communications skills to ensure data integrity and training of junior analysts as they join the team in the near future. 

A  minimum of 5 years experience as a QC Lab testing analyst is essential along with a Bachelors or Masters degree in Chemistry or Biochemistry.  It is key that you have understanding and efficient use of compendial methods and general chapters from USP and EP as well as thorough understanding of HPFBI and FDA GMP as it relates to QC Laboratory testing to release RX products.

Location - GTA

Salary - $60-70K

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


QUALITY ASSURANCE SPECIALIST, RX PRODUCTS, GMP,  CANADIAN, US, EU REGULATIONS,  GTA TO $55K

We are currently seeking a Quality Assurance specialist to manage and deliver compliant GMP and Quality systems including Change Controls, CAPAs, OOT/OOS and Training record systems.

As QA Specialist, you will:  Review and approve CoAs and other quality documentation, review validation activities, assess regulations, develop quality polices, perform timely data review to ensure high quality accuracy and completeness of analytical testing documentation, oversee QC documentation to enforce GDP, improve accuracy, GMP compliance and clarity in analytical documentation, verify calculations and documented information such as reagent expiry, instrument calibration, logbook entries, control charts for accuracy, review internal logbooks for incoming samples, standards, reagents, equipment, ensure analysis performed as per client's specifications, implement Quality policies and Procedures for on-site test activities, develop, implement and update QA Manual, QA Supplement Manual and SOPs, archive and retrieve QC data, Audit and inspect Laboratory operations and activities, audit and review data for accuracy and completeness for regulatory compliance, detailed Audits of draft reports for compliance with SOPs and GLP regulations.

As QA Specialist you will lead initiatives for Audit readiness, performing annual internal audits and working with Lab personnel to ensure total Quality compliance with Health Canada.

You must have at least 3 years of experience in GMP QA for Canadian markets.  EU and US Quality compliance experience is an asset. GMP, GLP, Compendia and Analytical techniques would be very useful  to know in this role.

As this position focuses on details, accuracy and delivery of Quality compliant documentation, you must have superior writing and editing communications skills.  Your ability to prioritize work tasks and focus on deliverables is key.

 Location - GTA

Salary - $55K

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


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