Manufacturing Operations Leader MSAT
Manufacturing Operations Lead, MSAT - Rockville, MD
Are you ready to lead a high-impact technical team in a dynamic biopharmaceutical environment? We are seeking a Manufacturing Operations Lead to head our newly formed Technical Execution Team at our Rockville, MD commercial facility. This team plays a critical role in ensuring the successful manufacture of commercial assets across two large-scale facilities (20kL and 10kL).
In this role, you will drive continuous improvement of existing bioprocesses, support daily operations, and collaborate across functions to deliver on complex global CMC strategies. You will also mentor a team of engineers and technical managers, fostering a high-performance culture.
Key Responsibilities:
- Lead and coach a team supporting multiple commercial products across two facilities.
- Collaborate with manufacturing, engineering, and quality teams to resolve complex DS bioprocessing challenges.
- Oversee CAPAs, Change Controls, Product Impact Assessments, and deviation management.
- Drive continuous improvement initiatives, including yield optimization and aseptic operations.
- Support RCA and DMAIC exercises to enhance business processes.
- Lead feasibility assessments for the introduction of new assets.
- Ensure seamless handoffs between manufacturing, engineering, and MSAT functions.
- Provide technical oversight and strategic input for global CMC submissions.
Basic Qualifications:
- Bachelor's degree.
- Minimum 10 years of experience in biopharmaceutical process development, MSAT, or CMC roles.
- Strong knowledge of ICH Guidelines, GMP principles, and commercial-scale operations.
- Proven experience with CAPA, Change Controls, and deviation support.
- Background in operational excellence and business process improvement.
- Deep understanding of upstream and downstream DS bioprocessing.
Preferred Qualifications:
- Demonstrated leadership and team management skills.
- Strong executive presence and cross-functional influencing capabilities.
- Experience leading impact assessments and root cause analyses.
- Ability to challenge the status quo and deliver innovative solutions.
- Excellent verbal and presentation communication skills.
- Proven ability to prioritize and deploy resources effectively.
This is a unique opportunity to shape the future of commercial manufacturing operations while advancing your career in a collaborative and fast-paced environment.
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