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Senior Operations Scientist
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Planet Pharma Group
Scarborough, ME (In Person)
$86,320 Salary, Full-Time
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Job Description
MAIN PURPOSE OF THE ROLE
Individual contributor with comprehensive knowledge in reagents manufacturing processes. Ability to plan and execute highly complex or specialized projects. Carries out complex/critical fundamental or applied research in the biological or physical sciences or in mathematics, requiring appreciable originality and ingenuity.MAIN RESPONSIBILITIES
- Draft validation protocols, execute validations, and draft validation reports for reagents manufacturing processes (i.e. mixing, pooling, cleaning) - operational qualification (OQ), test method validation (TMV), performance qualification (PQ), and process validation (PV) are all within scope
- Design of Experiments (DOE) involving different reagent combinations, concentrations, and operating conditions - coordinating execution, documenting results, and presenting findings
- Develop and maintain data tracking sheets for experiment results, critical process parameter (CPP) operating ranges, critical quality attribute (CQA) results across manufacturing events
- Utilize quality management system (QMS) for documentation of study results, complying to site design control and validation procedures
- Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, risk assessments, and procedures and other technical documents to insure compliant, efficient and safe processes.
- Use design for manufacturability (DFM) principles to make recommendations for design improvements
- Work cross-functionally with R D and QA to develop study plans and execute process & design improvements Required Qualifications
- Bachelors degree (BS) in Biology, Chemistry, Engineering or similar scientific/technical discipline
- 6+ years of experience in a scientific/technical role in Operations or R D
- Proficient with statistical analysis software (Minitab or JMP preferred) Preferred Qualifications
- Masters degree in Biology, Chemistry, Engineering or similar scientific/technical discipline
- Exposure to diagnostics and immunoassay technologies
- Experience with data science/data visualization highly preferred
- Familiarity with basic project management tools and principles (i.