Associate Director, Manufacturing Technical Operations

About This Role:

This critical position provides operational oversight of the Manufacturing Technical Operations (MTO) function for the Small Scale Manufacturing (SSM) and Flexible Volume Manufacturing (FVM) factories at Biogen's RTP Bio Site. This role ensures tech transfers are properly supported by the technical unit operation owners managing manufacturing documentation changes (e.g. batch production record, procedure, and change control) and providing deep technical knowledge on restart readiness for existing clinical and commercial products as well as new product introduction for both internal and external programs. The incumbent is expected to drive standardization across factories, ensuring end-to-end thinking and visibility in systems, processes, and tools (including global alignment). The incumbent will work strategically with cross functional groups like Quality, Manufacturing Sciences, Manufacturing, Engineering, and Technical Learning on short, mid, and long-term plans to ensure systems, people and processes are working in a coordinated fashion towards achieving site goals.

What You'll Do:

• Effectively lead and coach direct reports to meet career goals and business objectives. Addresses human resource development opportunities and challenges. Actively participate in hiring the best talent and work to develop an exceptional workforce.
• Develop, plan, and lead all activities within scope of Manufacturing Technical Operations by leading and coaching the MTO team toward supporting tech transfers, driving continuous improvement and changes, ensuring manufacturing instructions are clear, safe, and compliant. You will work on a cross-site and global level to ensure alignment and standardization where appropriate.
• Develop and lead critical manufacturing support improvement initiatives. This will include MFG data management, batch performance metrics, and lot disposition efficiencies.
• Engage in strategic and/or global activities and apply strategies to your department. Participate in a variety of strategy-related teams such as CMC, cross-site teams, global practices teams, information technology, regulatory submission teams, and compliance improvement teams.

• Bachelor's Degree in Life Sciences, Engineering or related field
• A minimum of 10 years' experience in a biopharmaceutical / pharmaceutical manufacturing environment.
• Practical knowledge and application of cGMP, cGLP and EMA compliance regulations and inspections
• Demonstrated experience as a leader in a pharmaceutical manufacturing environment: growing and developing staff from a technical and leadership perspective.
• Knowledgeable about other aspects of pharmaceutical operations including QA, QC, and Engineering
• Excellent interpersonal skills including the ability to influence behaviors plus negotiate and resolve challenges with poise, tact, and diplomacy
• Excellent oral and written communication skills to all employment levels and to Senior Leadership
• Demonstrated ability to grow and develop staff from a technical and leadership perspective

• 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