Role
Lead a group of manufacturing staff in the execution of lateโstage clinical and commercial biologics manufacturing operations, including cell culture, purification, and media/solutions preparation. This position requires significant onโtheโfloor presence and leadership, focused specifically on dayโtoโday operations using disposableโbased manufacturing technologies and ensuring cGMP compliance. Additional responsibilities include troubleshooting and/or providing technical expertise, finite scheduling, ensuring staff training compliance, executing against approved written procedures, participating in commissioning and validation activities, maintaining required cGMPโcompliant systems, and providing support for regulatory and site inspections.
Education and Qualification Requirements
- Bachelorโs degree in biological or engineering science
- 15+ years relevant experience
- Technical mastery of cell culture, purification, and solution preparation operations using disposableโbased manufacturing technologies
- Proven knowledge of cGMP requirements to ensure compliance
- Previous experience managing the activities of both individuals and large groups of staff
- Inโdepth knowledge of equipment, operations, and engineering principles
- Strong focus on quality and attention to detail
- Effective task/time management and organizational skills
- Motivated, selfโstarter with strong mechanical aptitude
- Excellent interpersonal, team, and communication skills โ both oral and written
Preferred Qualifications
- Strong understanding of process automation (e.g., DeltaV) and BAS systems
- Commissioning and validation experience, including risk assessments, user requirement specifications, execution of DQ, IQ, OQ, and PQ activities, and validation summary reports
- Applies knowledge and expertise to solve complex technical problems
- Significant contributor to multidisciplinary teams at the functional level
- Mentors and provides technical advice to individuals within the team
- Thorough working knowledge of US FDA CFRs and European EMA, including ICH regulations
Benefits
- Base pay range for this exempt, salaried position: $190,000 โ $225,000 at commencement of employment
- Discretionary annual bonus
- Comprehensive benefits including medical, dental, vision, shortโterm and longโterm disability, companyโpaid basic life insurance, 401(k) company match
- Flexible work, generous paid time off, paid holiday, wellness and transportation benefits
Equal Opportunity Employer
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
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