Senior Operations Scientist
Spectraforce
Scarborough, Maine
2 hours ago
Job Description
Job Title: Senior Operations Scientist
Location: Scarborough, Maine; 04074
Duration: 06 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)
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 43.55/daily.
Location: Scarborough, Maine; 04074
Duration: 06 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)
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 43.55/daily.