External Site Lead, Global External Manufacturing
About The Position
As an External Site Lead, within our Global External Manufacturing Team, you will be pivotal in overseeing our partnerships with Contract Development and Manufacturing Organizations (CDMOs). The site lead will oversee all activities to ensure seamless manufacturing operations. Your technical expertise in assembly and packaging pharmaceutical and biologics will be crucial as you lead the process control strategy and execution at external manufacturing sites. You'll drive matrix teams to provide operational oversight, manage change controls, analyze scientific datasets, and ensure compliance with regulations. Your role is essential for aligning manufacturing objectives, enhancing efficiency, and fostering continuous improvements that bring value to the business. Collaborating across all levels and functions, you will ensure the delivery of high-quality manufacturing operations, fitting into the broader organizational structure.
Requirements
- Bachelor’s degree in related field, preferably in Engineering discipline, and a minimum of 7 years of experience.
- Expertise in device assembly and/or label and packaging.
- Experience in Operations or Supplier Relationship Management.
- Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification.
- Expertise in external CDMO management, governance, contracting, and relationship management.
- Proficiency in project management and communication skills for leading cross-functional teams.
- Strong analytical and written skills, with the ability to drive impactful decisions.
Nice To Haves
- You are someone with a strong technical understanding of assembly, label and packaging with business acumen to drive the business.
- Your ability to make impactful decisions and act with urgency sets you apart.
- You thrive in cross-functional and multicultural environments, expertly managing conflict and providing clear direction.
- You possess good communication and project management skills, enabling you to lead effectively with internal and external teams.
- Your expertise in control strategies, regulatory compliance and CDMO management makes you a valuable asset to our team.
Responsibilities
- Manage and oversee CDMO relationships with a focus on manufacturing execution.
- Provide technical and operational oversight for assembly, label and pack.
- Manage global change controls and deviations effectively.
- Drive, manage, and deliver technology transfers.
- Analyze scientific datasets to ensure robust process control strategies.
- Author and review site-specific Continuous Process Verification (CPV) reports.
- Develop and implement corrective actions and drive business process optimization.
- Lead continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness.
- Manage supplier relationship activities from contract negotiation to execution.
- Conduct business performance reviews and manage partner governance.
- Act as a primary engagement leader and actively monitor performance.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
