Principal External Manufacturing Specialist (Drug Product)
$78,700–$150,600 year
On-siteRensselaer, New York, United States
Job Summary
Oversee all aspects of external manufacturing contract operations, including scheduling batches, supplying materials, directing shipments, and tracking cycle times. Coordinate activities at multiple sites while liaising with Quality Control, Supply Chain, and contract manufacturers to ensure timely documentation and cGMP compliance. Lead sub-teams in continuous process improvements, support investigations into manufacturing and shipping operations, and perform reviews of pre-production and executed batch records. Analyze data for trends, author procedures, and support internal and external audits. Travel 25% domestically and internationally as required.
Required Qualifications
- BS/BA in a scientific discipline
- 5+ years of experience in cGMP manufacturing operations (clinical and/or commercial external manufacturing)
- 8+ years of experience in cGMP manufacturing operations (clinical and/or commercial external manufacturing)
- Experience collaborating with CMOs/CROs
- Knowledge of external manufacturing from formulation through the final package
- Knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
- Proficiency in Excel, PowerPoint, Visio, Word, Oracle
- Experience working within shared work environments
- Strong interpersonal, written and oral communication skills
- High emotional IQ
- Ability to impart understanding of provided instructions, develop instructions and sets and works towards goals with minimal supervision
- A degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments
- Resiliency and flexibility in the face of challenges and adversarial situations
- Understanding and listening to team members and stakeholders needs while supporting productive team environments toward a common objective
- Travel 25% (target) or more (domestic and international), as required
- Monday-Friday, 8am-4:30pm
- Location: East Greenbush, New York, United States
Desired Qualifications
- Experience with shared work environments
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