Senior Manager, Cell Culture Development : Pilot Scale - (research triangle park, north carolina) in Raleigh, North Carolina For Sale

External Posting TitleSenior Manager, Cell Culture Development : Pilot Scale
Job DescriptionAs a member of Biogen's Cell Culture Development team, the candidate will be responsible for the managing the cell culture aspects of the Technical Development Pilot Facility. The candidate will supervise a group of engineers and scientists responsible for the scale up runs of all the pipeline projects for biologics including pilot runs for toxicology material generation. The ability to manage their team to work efficiently, maintain operational excellence, to meet project timelines and to influence other stakeholders across the development organization is a key responsibility of this position. The candidate will also play a significant role in the assessment and development of new innovative technologies and enhance fundamental scale up understanding that will be crucial for successful scale up of our cell culture processes.
Essential responsibilities of this position include:
1) Lead cell culture pilot scale team with : 10 members at two locations and oversee all aspects of lab operation including but not limited to run performance, innovation, and safety.
2) Provide guidance to cell culture process scale:up activities including robustness evaluation and risk mitigation.
3) Assist investigation of process and product differences across sites and scales including real:time trouble:shooting during manufacturing campaigns
4) Propose and manage comprehensive engineering projects such as equipment and automation upgrade to improve efficiency or increase capacity
5) Coordinate with other departments especially CMC team for run scheduling and to align the expectation with goal. Support regulatory filings.
6) Serve as important liaison to external partners on process transfer, operation alignment, robustness evaluation, and facility fit
7) Create a clear vision and identify technology gaps for future improvement. Develop strategies including initiating academic collaborations to close the gap
8) Stay current with industry trends and technical development and focus on continuous process improvement. Actively involved in industrial discussion and collaboration.
9) Evaluate/develop new technologies and drive for implementation at manufacturing scale through cross:functional collaborations
10) Support budget planning and execution in pilot scale lab
11) Career development and guidance for the team
*LI:POT1
LocationResearch Triangle Park, NC, US
Job CategoryTechnical Development
Requisition Numberxxxx4BR
Qualifications: Hands on experience with pilot scale bioreactor (both stainless steel and SUB) operation preferred : Deep understanding of bioreactor engineering/characterization and equipment : Expertise in cell culture process scale:up/scale down as well as large scale trouble:shooting : Demonstrated ability to drive technology innovation and implementation : Demonstrated ability to manage multiple operational and/or scientific projects/activities : Strong engineering background with solid data analysis and mathematic modeling skills : Ability to communicate and connect with all levels of the organization including influence without authority and facilitation of collaboration among various stakeholders : Proven record of leadership including strategic thinking, decision making, motivating group members, and driving for results to meet or exceed expectations : Self:motivated with a strong work ethic. : Demonstrated people management by supporting career development and managing team dynamics
EducationChemical Engineering or related majors. B.S. with : 13 years industry experience or Master with : 11 years industry experience or Ph.D. with : 5 years industry experience.
About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Pa
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