Senior Operations Scientist

Title: Senior Operations Scientist

Location: Scarborough, Maine

Duration: 6 Months

100% Onsite

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 findingsDevelop and maintain data tracking sheets for experiment results, critical process parameter (CPP) operating ranges.
• Critical quality attribute (CQA) results across manufacturing eventsUtilize 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 improvementsWork 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)

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.