Jobs

Description

Manager's Update

• Draft validation protocols for reagent manufacturing processes (e.g., mixing, pooling, cleaning).
• Minimum 6+ years of experience required.
• Background in R&D or medical devices is preferred.
• Strong experience in validation protocols and drafting validation documents.
• Experience in data management, including collecting and presenting data.
• Basic project management skills.
• General experience in validation is required.
• A master’s degree is preferred.
• Draft and execute validation protocols.
• Develop characterization processes.
• Operational Qualification (OQ), Test Method Validation (TMV) Essential
• Performance Qualification (PQ), Process Validation (PV) secondary
• Execute discrete deliverables, from drafting protocols to obtaining cross-functional buy-in and resource allocation.
• Hands-on lab experience is preferred over purely manufacturing floor experience.
• Experience in upstream or downstream bioprocessing is acceptable.
• Familiarity with manufacturing processes.
• Experience in manufacturing process validation is preferred.
• Analytical process validation experience is also acceptable.
• Knowledge of change control, deviations, or CAPA is a nice-to-have (training can be provided).
• Experience with Power BI is a plus
• Bachelor’s Degree: 6+ years of scientific/technical experience in Operations or R&D.
• Master’s Degree: 4+ years of relevant experience.
• PhD: 2+ years of relevant experience.
• Candidates with relocation availability will be considered
• Involvement in developing manufacturing processes is expected.

3 primary responsibilities,

• Validation - key skill. Operations Qualifications
• Process Validation for reagent processes, mixing chemicals, evaluating solutions.
• Data Management - Also important - data mgmt, data science background helpful, synth diff data sets generate visualization, what can we conclude from these results
• Working on manufacturing events, will be collecting a lot of data - synthesize, generate dashboards and what does the data mean? Validation skillset is the most important.
• 3rd responsibility - ability to write study protocols, be able to execute study, results, interpret results.
• Experience in diagnostics, amino assays, how to handle fluids, aware of best practices re: risk of contamination, so good practices are important.
• Lab Experience necessary? Yes, someone with work experience and comfortable in a lab, hands on.
• Education qualifications necessary, Bachelors degree in scientific background required
• Masters or PhD preferred. Nothing would be considered overqualified.

Length of contract - 6 months duration. Is there a possibility to extend? Yes

Relocate at own expenses ok, can be considered? Yes would consider candidates willing to relocate at own expense.

Start with local Maine area first, then New England, then rest of the country.

Opportunity to go FT? No, not at this time and should not be used as a selling point while recruiting for role.

Key Skills to screen for per the manager: Validation experience, data science management

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)