Pharmaceutical Data Reviewer Analytical Development

4 months ago

Mississauga, Canada Biolab Pharma Ltd Full time

**JOB OPPORTUNITY**
**Title: DATA REVIEWER ANALYTICAL DEVELOPMENT R&D**
**Reports to: R&D QA & Technical Documentation Manager**

The Analytical Development data reviewer assists and supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. Responsible and accountable for independently reviewing all data associated with developing, transferring, verifying or validating analytical test methods; for reviewing all data associated with chemical and physical laboratory tests on raw materials and R&D samples: in-process, finished product, stability, Preformulation, etc., required during product development and/or to release GMP supplies intended for formal stability studies and/or clinical studies.

**Key job responsibilities and duties**:

- Perform activities in the analytical development area to support the development of new products and analytical methodologies per departmental SOP’s and ICH guidelines.
- Review analytical data to ensure that it is completed correctly, in line with data integrity guidelines, free from errors, omissions, or defects to comply with cGMP.
- Review raw data from the testing of raw materials, in-process samples and finished products in a timely & efficient manner to ensure quality and efficacy of the product.
- Review analytical data associated with the development, transfer, or validation of robust, sound analytical methods.
- Review test methods, validation protocols and reports as applicable.
- Perform peer review of notebook and data generated by other personnel in the analytical development laboratory.
- Review data related to the qualification, maintenance and calibration of R&D analytical development equipment
- Support the preparation of submission documentation
- Identify and make recommendations for improvements to ensure continuous improvement.
- Ensure all analytical and other lab activities are carried out in compliance with the required standards conforming to company’s policies, cGxP, SOPs, regulatory regulations and guidelines, and safety and environmental guidelines.
- Support internal projects and external Contract Manufacturing Organization projects in alignment with Biolab’s objectives and initiatives.
- Take part in /lead Laboratory Investigations and change controls.
- Assist in the preparation for internal/regulatory inspections
- Education and experience requirements:

- Canadian equivalent to Master of Science or Bachelor of Science degree, preferably in Pharmacy, Chemistry, or Pharmaceutical Chemistry or related scientific discipline required.
- More than two years of relevant hands on pharmaceutical experience in product development. Demonstrates knowledge and experience of analytical chemistry by successfully operating analytical instrumentation such as HPLC, UV/Vis, GC, dissolution apparatus. Understanding of the principles used in DOE, risk based assessment tools, quality by design, method validation, equipment troubleshooting and technical transfer. Experience with Chromeleon software is preferred.
- Ability to work independently or as a part of a team.
- Highly motivated and have the skills to handle multiple projects and prioritize the work.
- Excellent communication skills (oral and written) and interpersonal skills are required

Pay: Up to $65,000.00 per year

**Benefits**:

- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Tuition reimbursement
- Vision care

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Pharmaceutical Analytical Development: 3 years (required)

**Location**:

- Mississauga, ON L4W 0B3 (preferred)

Work Location: In person

  • R&d Data Reviewer

    4 months ago

    Mississauga, Canada Biolab Pharma Ltd Full time

    **Key job responsibilities and duties**: - Perform activities in the analytical development area to support the development of new products and analyticalmethodologies per departmental SOP’s and ICH guidelines. - Review analytical data to ensure that it is completed correctly, in line with data integrity guidelines, free from errors, omissions, or defects...

  • Pharmaceutical R&d Analytical Development Scientist

    3 months ago

    Mississauga, Canada Biolab Pharma Full time

    **Title: SCIENTIST ANALYTICAL DEVELOPMENT** **Reports to: Manager Analytical Development** The analytical development scientist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by using knowledge and innovation of science, technology and chemistry to...

  • Pharmaceutical R&d Associate Scientist Analytical

    1 month ago

    Mississauga, Canada Biolab Pharma Full time

    **JOB OPPORTUNITY** **Title: Associate Scientist Analytical Development** **Reports to: Manager Analytical Development** The analytical development associate scientist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by using knowledge and innovation of...

  • Pharmaceutical R&d Associate Scientist Analytical

    3 months ago

    Mississauga, Canada Biolab Pharma Full time

    **JOB OPPORTUNITY** **Title: Associate Scientist Analytical Development** **Reports to: Manager Analytical Development** The analytical development associate scientist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by using knowledge and innovation of...

  • Analytical Development Scientist

    3 months ago

    Mississauga, Canada Biolab Pharma Full time

    **Title: SCIENTIST ANALYTICAL DEVELOPMENT** **Reports to: Associate Manager Analytical Development** The analytical development scientist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by using knowledge and innovation of science, technology and...

  • Research Scientist, Pharmaceutical Development

    3 weeks ago

    Mississauga, Ontario, Canada Cari Full time

    Job SummaryCari is seeking a highly skilled Research Scientist to join our Pharmaceutical Development team. As a key member of our team, you will be responsible for developing and validating analytical testing procedures for drug substances and drug products.Key ResponsibilitiesMethod Development and Validation: Develop and validate analytical testing...

  • Research Scientist, Pharmaceutical Development

    3 weeks ago

    Mississauga, Ontario, Canada Cari Full time

    Job SummaryCari is seeking a highly skilled Research Scientist to join our Pharmaceutical Development team. As a key member of our team, you will be responsible for developing and validating analytical testing procedures for drug substances and drug products.Key ResponsibilitiesMethod Development and Validation: Develop and validate analytical testing...

  • Analytical Report Reviewer II

    1 month ago

    Mississauga, Ontario, Canada Thermo Fisher Scientific Full time

    Position Overview: The role involves the independent evaluation of various technical documents and raw data produced in laboratory operations. Key Responsibilities: • Conduct thorough reviews of all standard technical documents, including batch testing, stability assessments, and method validation, ensuring high-quality output delivered within established...

  • Associate Scientist Analytical Development

    3 months ago

    Mississauga, Canada Biolab Pharma Full time

    **JOB OPPORTUNITY** **Title: Associate Scientist Analytical Development** **Reports to: Associate Manager Analytical Development** The analytical development associate scientist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by using knowledge and...

  • Analytical Operations Documentation Reviewer I

    4 months ago

    Mississauga, Canada Thermo Fisher Scientific Full time

    **Summary**: Responsible for independently reviewing various technical reports and raw data generated in Lab Operations. **Essential Functions**: - Review with minimum supervision all regular technical documents (e.g., batch testing, stability testing, raw materials, swabs and method validation) and raw data generated in the Laboratories with high quality...

  • Analytical Operations Documentation Reviewer I

    4 months ago

    Mississauga, Canada Thermo Fisher Scientific Full time

    **Summary**: Responsible for independently reviewing various technical reports and raw data generated in Lab Operations. **Essential Functions**: - Review with minimum supervision all regular technical documents (e.g., batch testing, stability testing, raw materials, swabs and method validation) and raw data generated in the Laboratories with high quality...

  • Junior Microbiologist

    3 months ago

    Mississauga, Canada Canadian Analytical Laboratories Full time

    A career with **Canadian Analytical Laboratories** provides an opportunity to work with a diverse group of people, from various backgrounds and professions, in an organization that is growing and evolving to make lives better and safer through analytical testing and research. **Job Summary**: To conduct, with minimum supervision, microbiological analysis of...

  • Pharmaceutical Building and Utilities Specialist

    3 months ago

    Mississauga, Canada Biolab Pharma Ltd Full time

    The Pharmaceutical Building and Utilities Specialist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. The R&D Utilities Specialist Technologist will ensure Research and Development facility and utilities (HVAC, Compressed air, purified water, etc.,) are installed, qualified, validated,...

  • Qc Chemist

    5 days ago

    Mississauga, Canada Bora Pharmaceutical Services Full time

    **Location**: - Mississauga, ON**Date Posted**: - 9/25/2024**Job Number**: - JO-2409-1825- Bora Pharmaceuticals is a global leader in the development and manufacturing of branded, generic, and over the counter (OTC) healthcare and pharmaceutical products. Our mission is to ensure the mutual success of our partners by maintaining high standards of quality,...

  • Preconstruction Manager

    3 months ago

    Mississauga, Canada EllisDon Corporation Full time

    **_Connect with us _**_LinkedIn_**_, _**_Instagram_**_, _**_Facebook_**_, _**_Twitter_** **_ Thinking about a change? _** We recognize that the construction industry is changing at a rapid pace and we continually strive to be at the forefront. Our core **values** empower people to deliver great careers to one another and develop creative solutions for...

  • Pharmaceutical Value Analyst, Clinical Services

    3 weeks ago

    Mississauga, Ontario, Canada The Cigna Group Full time

    About the RoleWe are seeking a highly skilled Pharmacoeconomic Strategist to join our Clinical Services team at The Cigna Group. As a key member of our team, you will play a pivotal role in providing pharmacoeconomic expertise to optimize pharmacy benefit management products from both clinical and economic perspectives.Key ResponsibilitiesDesign and...

  • Pharmaceutical Value Analyst, Clinical Services

    3 weeks ago

    Mississauga, Ontario, Canada The Cigna Group Full time

    About the RoleWe are seeking a highly skilled Pharmacoeconomic Strategist to join our Clinical Services team at The Cigna Group. As a key member of our team, you will play a pivotal role in providing pharmacoeconomic expertise to optimize pharmacy benefit management products from both clinical and economic perspectives.Key ResponsibilitiesDesign and...

  • Laboratory Coordinator

    5 days ago

    Mississauga, Canada Canadian Analytical Laboratories Full time

    A career with **Canadian Analytical Laboratories** provides an opportunity to work with a diverse group of people, from various backgrounds and professions, in an organization that is growing and evolving to make lives better and safer through analytical testing and research. The **Laboratory Coordinator/Customer Service **associate is accountable to the...

  • Analytics Translator

    4 months ago

    Mississauga, Canada Bayer Crop Science Full time

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...

  • Analytics Translator

    3 months ago

    Mississauga, Canada Bayer Full time

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...