Pharmaceutical Analytical Chemist

2 weeks ago

Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals.

We work with our partners to transform patients' lives by advancing high quality drugs for the treatment and diagnosis of diseases.

We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe.

Start your career with AtomVie today and help us achieve our vision:
to transform lives by revolutionizing healthcare.

Senior Analytical Chemist is an expert in quality control testing of pharmaceutical drug products and experienced in the areas of analytical test method development (HPLC, GC, etc.), They provide technical leadership and project management support to the Analytical Development, Production and QA teams at AtomVie.

The incumbent establishes work schedules and monitors assignments to ensure the successful completion of tasks in a timely fashion while ensuring consistent high quality in a constant effort to provide best support to the organization with professionalism and integrity.

Plan, implement and successfully complete assigned Analytical Development and Quality Control projects and tasks in a timely fashion while ensuring consistent high quality.

Define comprehensive and complex validation procedures for all analytical methods based on scientific knowledge, experience and support from SMEs.

Perform routine and complex validation activities independently per approved protocols, and provide guidance and oversight to junior staff working on these activities
Write test reports, data summaries, and statistical evaluations/trending.
Initiate change controls to implement/revise/improve programs and methods and monitor completion of all work in a timely fashion.
Write (author), revise, and review technical documents, validation documents (protocols, reports), STMs, SOPs, specifications, change controls, etc.

according to regulatory guidelines (ICH, USP, etc.) Prepare presentations for client review to summarize results and project status updates and participate in client meetings.

Perform quality control (release & retrospective) testing of incoming materials, drug substances, and finished drug products according to standard testing methods (STMs), including Chemical (e.g.

ELISA, IRF, Protein content), and Microbiological (e.g. Bacterial Endotoxin) testing methods.

Coordinate quality control (release &retrospective) testing of drug substances and raw materials with contract laboratories or contract research organizations according to standard testing procedures, USP or EP.

Assist QA in the management of third-party analytical testing service providers and vendor qualification.
Conduct peer review of laboratory record and notebooks for AD/QC; create the release certificate of analysis.
Conduct investigations for testing failure and non-conformances and implement corrective actions.
Write technical documents (e.g. author/create specifications, test reports, data summaries, investigations, CAPAs); prepare CAPA implementation plans and take an active role in closing laboratory investigations.
Responsible for training other colleagues, colleagues from other departments, and new staff in all department related disciplines.

Perform routine quality operations including calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures and analytical reagents, when required.

Responsible for new equipment purchases and installation (quotes, URS, change control, SOPS, STMs, forms, IQ/OQ/PQ, etc.)

Responsible for the housekeeping of the facility including the disposal of hazardous waste (chemical and radioactive) through the appropriate waste-streams.

Monitor effectiveness of the housekeeping and waste procedures and implement improvements.
Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety (e.g. radioactive material transfer forms).

Adhere to GMP regulations by maintaining complete records pertaining to all aspects of training, analytical testing, routine operations, and equipment maintenance.

Maintain an up-to-date training record.
Experience in QC testing of materials and products using HPLC, GC, TLC, etc.
Skilled in data interpretation of UV, IR, MS, and NMR spectra.
and proficiency in chemical analysis.

Experience with sterile products, a background in working in a BSL2 laboratory, and knowledge of microbiological testing (Bioburden, Sterility, Bacterial Endotoxins) is considered an asset.

Excel, Google Sheets) with the ability to rapidly input data and retrieve records, statistics, trends, etc.
Strong writing skills, including the ability to compose technical documents, reports, and presentations for customer meetings.

Excellent communication skills in English, coupled with the ability to work both independently and collaboratively in a team environment.

Degree in Chemistry, Biological Chemistry or Biotechnology.
~ Flexibility in work schedule to support a 7-day work week and manufacturing/client demand at varying times (early morning/late evening).
~ Group Health & Dental Benefits (from day 1)
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process.

  • Analytical Chemist

    2 weeks ago

    Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

    AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.About the Role*The Analytical Chemist is responsible for working in accordance with...

  • Analytical Chemist

    2 weeks ago

    Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

    AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients' lives by advancing high quality drugs for the treatment and diagnosis of diseases.We are a community that challenges ourselves professionally, takes pride in what we can...

  • QA - Data Reviewer, Associate

    2 weeks ago

    Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

    AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients' lives by advancing high quality drugs for the treatment and diagnosis of diseases.We are a community that challenges ourselves professionally, takes pride in what we can...

  • Manager II, Omnichannel Analytics

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    Area of Interest: Market Analytics & Business IntelligenceAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience,...

  • Senior Manager, Customer Analytics

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...

  • Senior Manager, Customer Analytics

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...

  • Process Development Radiochemist I

    2 weeks ago

    Hamilton, Ontario, Canada Fusion Pharmaceuticals US Inc Full time

    Fusion Pharmaceuticals (NASDAQ:FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors.Fusion's clinical portfolio includes: FPI-2265 targeting...

  • Associate Director, Marketing Delivery

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan...

  • Process Development Radiochemist

    2 weeks ago

    Hamilton, Ontario, Canada Fusion Pharmaceuticals US Inc Full time

    Fusion Pharmaceuticals (NASDAQ:FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors.Fusion's clinical portfolio includes: FPI-2265 targeting...

  • Medical Advisor, Rheumatology

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    __jobinformationwidget.freetext.LocationText__ AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care...

  • Director of Logistics

    2 weeks ago

    Hamilton, Ontario, Canada Fusion Pharmaceuticals Full time

    Fusion Pharmaceuticals (NASDAQ:FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors.Fusion's clinical portfolio includes: FPI-2265 targeting...

  • Senior Manager, Medical Planning

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan...

  • Director, R&D Research Project Management

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    Director, R&D Research Project Management __jobinformationwidget.freetext.LocationText__Irvine, CA Function: Research & Development Area of Interest: Analytical Research & DevelopmentAt Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial...

  • Business development for Services

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    Head, Clinical Operations - Business Insights, Study Feasibility & Patient Recruitment Research & Development Pharmaceutical Development AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's...

  • Senior Service Management Analyst

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan...

  • Human Resources Recruiter/ Talent Acquisition

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan...

  • Director, Business Development, Global Commercial Oncology

    2 weeks ago

    Hamilton, Ontario, Canada Allergan Full time

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...

  • Director of Logistics

    1 month ago

    Hamilton, Ontario, Ontario, Canada Fusion Pharmaceuticals Full time

    Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting...

  • Director of Logistics

    4 weeks ago

    Hamilton, Ontario, Ontario, Canada Fusion Pharmaceuticals Full time

    Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting...

  • Production Technician

    2 weeks ago

    Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

    Work Term: Permanent Work Language: English Hours: 37.5 hours per week Education: Other trades certificate or diploma Experience: Experience an asset- or equivalent experienceTasks: Assist in set up and conduction of chemical experiments Operate and maintain laboratory equipment and apparatus and prepare solutions of gas and liquid, reagents and sample...