The individual will be expected to monitor and provide support for manufacturing cell culture/purification operations. Responsibilities will include monitoring of the process and containment of process failures and deviations that occur during cell culture/purification processes and coordination of implementation of associated corrective and preventative actions. The individual will also participate and function as PTS 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 or downstream operations including but not limited to cell culture roller bottle/bioreactor and capture step operations, filtration (NF, UF/DF) unit operations, chromatography column performance/integrity and drug substance formulation/bottling.
- 30% Tech Transfer Support the transfer of phase I, II/III clinical processes into the existing GMP manufacturing facilities as define by Tech Transfer group
- 30% Continuous Improvement Work with manufacturing staff to identify opportunities to improve the consistency and robustness of process operations. Provide leadership in the development of mfg. training initiatives.
- 10% Quality System Support Lead consistent and well documented response to process operations events to support investigations, deviation closure as well assistance to change control/CAPA as appropriate.
Education and Experience Requirements:
- BS in Chemical/Biochemical Engineering or Chemistry with 8 to 12 years or MS with 6 to 10 years of process development / manufacturing experience for purification of recombinant proteins.
- Hands-on experience with large-scale cell culture/purification 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 purification manufacturing and/or process development experience, preferably with recombinant proteins.
- Candidate must have working knowledge of cGMPs and statistical analysis methods.
- 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.
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.
The candidate will:
- Develop solutions to complex problems which require the regular use of ingenuity and innovation. Ensures solutions are consistent with organization objectives.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.
- Contributes to the development of new concepts, techniques, and standards. Considered expert in field within the organization.
- Work is performed without appreciable direction. Exercises considerable latitude in determining objectives and approaches to assignment.
- Effects of decisions are long-lasting and heavily influence the future course of the organization. Errors in judgment or failure to achieve results would result in the expenditure of large amounts of company resources.
- Serves as consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives.
- The candidate will work under general direction and participate in determining objectives of assignment; plan schedules and arrange own activities in accomplishing objectives to meet customer needs.
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.