The Sr. Manager Operations will support clinical operations at our Princeton, NJ Biologics site.
How will you make an impact?
The Senior Manager Operations leads all manufacturing operations including manufacturing support services and all site GMP manufacturing.
What will you do?
· Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
· Ensures safe, quality, and timely manufacture of biopharmaceutical product for pre-clinical, clinical and commercial use
· Ensures that all production operations are controlled and executed within GMP regulatory guidelines.
· Provides for the identification and development of talent both within the team and across the site.
· Plans operations such that each project delivery is optimal, meeting the financial needs of the company while balancing the needs of customers and end users.
· Ensures the availability of appropriate SOPs and documentation are provided to enable timely GMP batch record release
· Ensure the financial performances of operations by monitoring and driving decisions that have positive impact on the financial results as reflected by: COGS, income statement, EBIDTA, associated allocations from others, standard costs, and production efficiencies.
· Develop and implement programs to drive operational excellence towards right first time and on-time delivery.
· Maintains good community relations with adjacent neighbors whether business, industrial, service providers, academic or households.
How will you get here?
· MS in biological science or engineering discipline
· Equivalent combinations of education, training, and relevant work experience may be considered.
· 10 years’ experience of managing biomanufacturing operations in a highly regulated environment.
· 10 years’ experience of operating multi-product biomanufacturing facilities to produce clinical and commercial APIs
· 10 years’ experience of leading teams
· Experience of biopharmaceutical drug development (>50 products), biopharmaceutical product launches (>3 launches) and commercial manufacture of Biologics API (>3 products)
Knowledge, Skills, Abilities
· Ability to drive safety, quality, functional, technical and operational excellence.
· Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
· Ability to drive Customer Experience and a Commitment to Excellence.
· Effective written, interpersonal, and presentation skills.
· Ability to work on multiple projects simultaneously
· Expert knowledge of mammalian cell culture products
· Expert knowledge in biopharmaceutical development
· Leadership of people in multi-disciplinary technical and scientific teams
· Expert knowledge of regulatory guidelines: EU, US, Australian, ICH, etc.
· Leader in Operational Excellence
· Ability to travel up to 20%
· Excellent MS Office skills