What are the responsibilities and job description for the Senior Scientist position at TalentBurst, an Inc 5000 company?
Title: Senior Operations Scientist
Location: Scarborough, Maine
Duration: 6 Months
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:
Bachelor s 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:
Master s 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.e. Smartsheet, Microsoft Project)
Salary : $40 - $50