Associate Director, Manufacturing Technical Operations
3 weeks ago
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 out RTP Bio Site. This position will ensure tech transfers are properly supported with 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. In addition, the incumbent is responsible for oversight of Sr. Training and Development Coordinators who support RTP BIO PO&T new hire on-boarding, on the job training, Centralized Learning System ticket approvals, and Corrective and Preventative Actions related to training compliance.
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.
- Support and collaborate with Site Training Leads in workload distribution and management for Sr. Training and Development Coordinators.
- 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 applies strategies to their department. Participates on a variety of strategy related teams such as CMC, cross-site teams, global practices teams, information technology, regulatory submission teams, and compliance improvement teams.
Required:
- 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 a leadership perspective.
- Knowledgeable about other aspects of pharmaceutical operations including QA, QC, Technical Learning, 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 a leadership perspective
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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