Scientist/Engineer Process Microbiology in Somerville

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Job DescriptionJob Description

Position Brand Description:

This position is responsible for contamination control support for biotechnology manufacturing processes, overseeing a robust Product Protection Control Strategy against adventitious agents and foreign materials in a cGMP environment, and building the organization’s knowledge of aseptic manufacturing operations. This role partners with Operations, QC Microbiology, Engineering, other TS/MS Scientists, and Quality on risk-based assessments, testing strategies and troubleshooting.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

Floor Support

1. Monitors (trends) in-process microbiological data and presents analyses in Manufacturing Process Team meetings.
2. Provide on-the-floor contamination control support for manufacturing processes including and maintenance of manufacturing support documentation (e.g. SOPs, trend analyses, evaluation protocols)
3. Assist/Lead deviation investigations. Troubleshoot suspected microbiological contamination incidents.
4. Collaborate with Operations and Engineering to implement equipment, procedure and/or automation improvements to mitigate identified contamination risk points.
5. Provide contamination control guidance on facility and process-related controls and changes.
6. Product Protection Control Strategy Oversight
7. Oversee process contamination prevention and control according to Product Protection Control Strategy.
8. Develop in-process microbiological acceptance criteria, sampling requirements, summations, procedures, and reports. Collaborate with QC Microbiology on specifications and microbiological control strategy.
9. Serve as subject matter expert for evaluation and mitigation of microbiological trends.
10. Technology Transfer & Cross-Functional Support
11. Support microbiological requirements for in-process hold time studies as well as small-scale studies to support hold time, resin cleaning, and other process validation activities.
12. Collaborate with Validation Technical Services on microbiological requirements for cleaning/SIP validation and facility/equipment qualification.
13. Collaborate with Quality Control in the development and execution of the facility-based environmental monitoring and clean utilities microbiology programs for the site.
14. External Interface
15. Build deep technical expertise in the area of responsibility.

Basic Requirements:

1. Knowledge of aseptic manufacturing operations.
2. Strong investigational skill, working knowledge of microbiology assay development and validation.
3. Demonstrated strong data-driven decision-making and problem-solving capabilities.
4. Demonstrated strong interpersonal skills in cross-functional teamwork environment.
5. Demonstrated strong communication skills, both oral and written. Technical writing including position papers, validation reports, and microbiological investigations.
6. Demonstrated ability to participate in and facilitate decision-making.

Education Requirements:

1. B.S. in Microbiology or related science or engineering with a minimum of 0-5 years experience in a cGMP biopharmaceutical manufacturing environment.
2. Position is a banded position; education and years of experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment will be considered for initial placement within the band.

Other Information:

1. Travel required.
2. Lifting not required.
3. Not required to be on call.
4. Shift work may apply.

This role is exempt and the anticipated compensation for this role is $72,000 - $116,000

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of , , , , , , or expression, , protected veteran status, , or any other legally protected status.

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