Key Role Responsibilities:
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
- Author, review and execute to method transfer protocols for new product introduction and compendial validation
- Ability to work directly from the USP or EP pharmacopeia to write protocols and execute methods.
- Expertise with analytical tests utilizing HPLC/UPLC, GC, UV, IR, FTIR, KF and other laboratory instruments.
- Assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations.
- Assess analytical methods and perform gap analysis on analytical method validations for NPI. Develop plan and timelines for method transfers, required improvements and justification with approval from team to ensure compliance.
- Conducts complex analytical (physical & chemical) testing of raw materials, in-process samples, finished products required for method transfer and validation.
- Reviews laboratory documentation in notebooks, attachments, chromatography software and specification sheets for accuracy, completeness and compliance with established SOPs, specifications and methods.
- Conducts the investigation of deviations, out of specification (OOS), and non-conformances. Writes reports as required.
- Verifies and processes analytical data for method transfer. Writes technical documents such as methods, specifications, SOPs, method validation protocols and reports, method transfer protocols and reports.
- Participates in general lab duties, including clean up, administration, logbook review and operations support.
- Other duties as assigned.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
- 4-6 years in a Pharmaceutical Analytical testing lab & supporting stability programs
- Bachelor's degree. in Chemistry, Biochemistry or related discipline
- Analytical Wet Chemistry Lab experience using the following methods/equipment: titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC assays
- High integrity and ensures adherence to procedural guidance and raises any identified issues to the QC Supervisor.
- Excellent attention to detail – able to thoroughly document and review work, while consistently identifying discrepancies or errors.
- Excellent communication skills both verbally and written - expresses own views clearly and constructively & confirms understanding.
- Acts with purpose, urgency, reliability and professionalism.
- Versatility to perform a wide variety of tasks, showing flexibility in work assignments and organization.
- High level of proficiency with Microsoft Office
- Leadership skills and experience
- Experience in an FDA, Canadian Health, and or EU regulated Pharmaceutical manufacturing
- Experience of USP methodologies
- Knowledge and experience with Continuous Improvement programs
- Troubleshooting of FTIR, UV/VIS, and dissolution apparatus
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation program sees nine R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s eleven manufacturing facilities across eight countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
More Info at www.bimedacareers.com