Wissenschaftlicher Mitarbeiter in Mikrobiologie bei MVZ diagnosticum GmbH. Verantwortlich für Projektleitung und fachliche Anleitung im medizinischen Labor.
EC
Hybrid Principal Scientist, Contamination Control Strategy – ADN RAMP Team
Posted 4 months ago
About the role
- Principal Scientist developing contamination control strategies for new pharmaceutical sites at Lilly. Leading the CCS development and collaborating with cross-functional teams for new site startups.
Responsibilities
- Responsible for the development, implementation and establishing ongoing monitoring of the Contamination Control Strategy (CCS) for new site facilities
- Design, implement, support validation of and maintenance of routine and Batch Specific environmental monitoring (EM) programs
- Liaise with engineering on the New Facility design requirements to support CCS
- Provide microbiological control strategy support for Raw Materials
- Liaise with Quality Assurance to ensure microbiological controls are considered
- Provide Microbiological support to C&Q and cleaning validation
- Ensure implementation of the microbiological requirements for the integrated product control strategy
- Provide direction on handling of non-conforming results
- Stay current with Industry trends and updates to applicable guidelines
Requirements
- BSc Microbiology, Biochemistry or related science field with 8-10 years’ experience in pharmaceutical manufacturing
- MSc Microbiology, Biochemistry or science-related field with minimum 5 years appropriate industry experience
- Deep technical interest and understanding of Contamination Control Strategy
- Excellent verbal and written communications skills
- Strong analytical and problem-solving skills
- Collaborative skills with operations, process engineering, QCL and other process team members
- Technical knowledge of microbial and viral product control
- Ability to coach others
- Ability to influence without authority
- Ability to clarify and simplify complex issues
- Strong trust building with peers and leaders
- Willing to work off-shift hours as needed to support project milestones and training of new employees.
Benefits
- Health insurance
- 401(k) matching
- Pension
- Vacation benefits
- Medical benefits
- Dental benefits
- Vision benefits
- Prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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