Associate Director Manufacturing NPI & Clinical Readiness
| Company | Bristol Myers Squibb |
|---|---|
| Location | Bothell, WA, USA |
| Salary | $172090 – $208500 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Expert or higher |
Requirements
- Bachelor’s or Graduate degree in Engineering, Life Sciences, or related fields.
- 10+ years of experience in pharmaceutical/biotech manufacturing, with a focus on new product introduction, tech transfer, and process validation.
- Proven experience leading cross-functional teams and managing complex projects in a regulated cGMP environment.
- Strong expertise in tech transfer, PPQ execution, and manufacturing readiness.
- Deep understanding of cGMPs, process validation, and regulatory requirements.
Responsibilities
- Develop and implement manufacturing readiness plans to ensure smooth integration of new products into commercial manufacturing.
- Partner with Manufacturing and Quality to identify gaps and execute readiness strategies.
- Lead risk assessments and mitigation planning to enhance process robustness.
- Own and drive manufacturing systems that support technology transfer strategies from clinical development through PPQ and commercial launch.
- Actively support site tech transfer teams during process comparability, process validation, and ensure seamless transition between sites.
- Collaborate with MSAT and development teams to improve tech transfer methodologies.
- Lead team of manufacturing through PPQ strategy and execution, ensuring alignment with regulatory expectations.
- Support the delivery of key PPQ milestones, including ensuring operational readiness, employee training, and data collection—with a safety first, quality always mindset.
- Support process validation lifecycle, ensuring processes meet regulatory and business requirements.
- Drive post-PPQ improvements and lifecycle management.
- Lead manufacturing NPI team and support cross-functional teams to ensure alignment on NPI execution.
- Serve as a site representative in network-level NPI manufacturing discussions.
- Communicate progress, risks, and mitigation plans to manufacturing senior leadership and stakeholders.
- Identify and drive process and operational improvements to enhance NPI efficiency.
- Implement best practices in tech transfer, PPQ execution, and manufacturing readiness.
- Leverage digital tools and data analytics for process optimization.
Preferred Qualifications
- Experience with cell therapy or biologics manufacturing preferred.