- The individual will be expected to monitor and provide support for manufacturing cell culture/recovery operations.
- Responsibilities will include monitoring of the process and containment of process failures and deviations that occur during cell culture/recovery processes and coordination of implementation of associated corrective and preventative actions.
- The individual will also participate and function as MS lead on technology transfer and process improvement teams.
- Leadership and guidance of junior staff members in certain situations will also be expected.
- 30% Floor Support Troubleshoot process issues; monitor and evaluate process operation data for upstream and recovery operations including but not limited to cell culture roller bottle/bioreactor, filtration (NF, UF/DF) unit operations and capture chromatography operations.
- 30% Tech Transfer Support the transfer of phase I, II/III clinical processes into the existing GMP manufacturing facilities as defined by Tech Transfer project teams. Includes support of PPQs, PAI and Filing strategies.
- 30% Continuous Improvement Lead and drive process based continuous improvement initiatives targeting yield improvement, process performance consistency and process deviation reduction.
- 10% Quality System Support Support process related quality systems such as deviations, GMP investigation and corrective actions (CAPAs/Change Controls). Lead technical input to QS team to drive to root cause and develop/implement effective solutions.
Education and Experience Requirements:
- BS in Chemical/Biochemical Engineering or Biochemistry with 8 to 12 years or MS with 6 to 10 years of process development/manufacturing experience with the production of recombinant proteins using mammalian cell culture expression/bioreactor systems.
- Hands-on experience with large-scale cell culture/recovery manufacturing processes, preferably with commercial or licensed products.
- A working familiarity with single use process systems, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment.
- A detailed knowledge of the science and technology for the major unit operations associated with manufacturing operations to include mammalian cell culture, bioreactors, fluid transfer, filtration, chromatography, CIP/SIP, and UF/DF processes.
- Experience with troubleshooting / problem solving and risk assessment / mitigation.
- Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations.
- Experience with process / technology transfers. Prior supervisory / management experience is a plus.
Key Skills, Abilities, and Competencies:
- Candidate must have mammalian cell culture manufacturing and/or process development experience, preferably with recombinant proteins.
- Candidate must have working knowledge of cGMPs and compliance factors associated with large scale GMP manufacturing.
- Candidate should be experienced with writing CMC sections of regulatory filings and supporting inspections by health authorities.
- A familiarity with software based statistical analysis programs as well as training in quality improvement techniques, operational excellence tools and project management is a plus.
- As an active participant on multiple cross-functional teams, the candidate must also demonstrate excellent written and verbal communication skills with demonstrated ability to lead teams for the resolution of complex technical issues as required.
Complexity and Problem Solving:
- Candidate will make complex decisions regarding product impact on a regular basis.
- Candidate will also be required to assess the requirements of processes against the capabilities of existing equipment/facilities interacting with cross-functional team members for review and resolution.
- Candidate must be able to work in a dynamic environment, be able to set and balance priorities, and serve as a change agent.
- Develop solutions to complex problems which require the regular use of ingenuity and innovation. Ensures solutions are consistent with organization objectives.
- Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results. Network with key contacts outside own area of expertise.
- Contribute to the development of new concepts, techniques, and standards. Considered expert in field within the organization.
- Work with minimal supervision. Exercise considerable latitude in determining objectives and approaches to assignment.
- Serves as consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.