Lilly Process Microbiologist - TS/MS in Branchburg, New Jersey
This position is responsible for leading process microbiological support for biotechnology manufacturing processes, overseeing a robust Product Protection Control Strategy against Adventitious Agents 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.
Lead deviation investigations. Troubleshoot suspected microbiological contamination incidents and be lead subject-matter-expert for microbiological processes and systems
Provide microbiology guidance on facility and process-related controls and changes
Provide on-the-floor microbiological support for manufacturing processes including generation and maintenance of manufacturing support documentation (e.g. SOPs, trend analyses, evaluation protocols)
Collaborate with Operations and Engineering to implement equipment, procedure and/or automation improvements to mitigate identified microbiological risk points
Product Protection Control Strategy Oversight
Oversee process contamination prevention and control according to Product Protection Control Strategy.
Develop in-process microbiological acceptance criteria, sampling requirements, summations, procedures and reports. Collaborate with QC Microbiology on specifications and microbiological control strategy
Serve as subject matter expert for evaluation and mitigation of microbiological trends
Technology Transfer & Cross-Functional Support
As needed, represent Process Microbiology on technology transfer teams to assure successful implementation of the transferred process on site. Partner with colleagues at both sending and receiving sites to transfer process knowledge, including viral clearance requirements as well as raw material and cell bank control strategies.
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
Collaborate with Validation Technical Services on microbiological requirements for cleaning/SIP validation and facility/equipment qualification
Build deep technical expertise in the area of responsibility
As required, serve as microbiological control strategy SME for regulatory inspections. Author/review CMC Sections for Regulatory Submissions
May attend and/or present at key conferences to further Lilly Branchburg’s biotech industry presence.
Advanced degree highly desirable.
Advanced knowledge of aseptic manufacturing operations.
Strong investigational skill, working knowledge of microbiology assay development and validation
Demonstrated strong data-driven decision-making and problem-solving capabilities
Demonstrated strong interpersonal skills (job requires significant customer/peer/management interaction) and leadership skills in cross-functional teamwork environment
Demonstrated strong communication skills, both oral and written. Technical writing including position papers, validation reports, and microbiological investigations
Demonstrated ability to participate in and facilitate decision-making
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Process Microbiologist - TS/MS
B.S. in Microbiology or related science with a minimum of 7 years experience in a cGMP biopharmaceutical manufacturing environment.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world
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