As a key member of the Manufacturing Sciences Commercial Manufacturing Support Laboratory group, this individual will be responsible for providing technical and scientific leadership to support upstream processes for commercial production and late stage clinical production of Biologics, including process and product investigations/troubleshooting, continuous process improvement and life-cycle management, technology transfer and process validation. This individual will lead or contribute as a key member of various cross- functional teams and will interacts extensively with other departments within Takeda, including Manufacturing, PTS, QA, QC, PD, Engineering and RA etc. The responsibilities will include:
- Leading and executing of continuous process improvements, aimed at improving robustness, capacity, and productivity.
- Implementation of effective and sustainable process control strategy including new Process and Analytical Technologies (PAT).
- Mentoring junior staff as required.
- 40% of time: Lead and execute continuous process improvements, aimed at improving robustness, capacity, and productivity. Provide technical expertise and leadership in identifying opportunities/areas, planning, designing and conducting experiments, analyzing data and documenting results towards continuous upstream process improvement, including reducing recurring deviations, and increasing level of safety and/or compliance.
- 15% of time: Provide technical expertise and leadership in trouble-shooting and root cause analysis for process discrepancies and quality investigations of complex technical nature.
- 15% of time: Support regulatory inspections and filings as an author and reviewer.
- 15% of time: Provide high quality of written study proposals, research and development reports, and investigation reports.
- 15% of time: Implement effective and sustainable process control strategy including new Process and Analytical Technologies(PAT).
Education and Experience Requirements:
This individual will have a minimum of:
- A PhD in Chemical Engineering or related disciplines with a minimum of 4 years of relevant experience in a biotechnology/pharmaceutical environment; or MS in Chemical Engineering or related disciplines with a minimum of 6 years of experience; or BS in Chemical Engineering or related disciplines with a minimum of 8 years of experience is required. At least 2 of those years should be with supervisory experience. Experience working in a laboratory is a must.
- Proven record of technical capabilities.
- Proven ability to work in a fast paced environment with demonstrated capacity tojuggle multiple tasks and demands.
- Hands-on experience in process characterization leading to definition of design space.
- Experience in development and implementation of process control strategy using QbD principles.
- Experience in implementation of disposables in manufacturing of biologics.
Key Skills, Abilities, and Competencies:
- Have excellent knowledge and experience with mammalian cell culture process development, scale-up and scale-down, tech transfer and GMP manufacturing support.
- Have experience in design-of-experiment (DoE) and the ability to analyze and interpret data collected.
- Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively.
- Be customer focused, results oriented, science driven and embrace values.
- Have the attitude to proactively learn new technologies and manage changes in upstream process development and improvement.
- Demonstrated ability to make risk based decisions.
- Have experience in GMP working environments.
- Have the ability to influence, motivate, and drive technical rigor when participating on cross-functional teams.
Complexity and Problem Solving:
The individual will be expected to:
- Develop plans and execute cell cultureprocess improvement, trouble-shooting and manufacturing technical support.
- Identify and assist in analyzing complex technical problems, then findingand implementing solutions.
- Apply fundamental scientific and biological principles to practical technical challenges.
- Under limited supervision, plan, design and direct experimental studies to be carried out by him/herself or others within his/her area.
- Work closely with his/her supervisor and coworkers in managing multiple work streams and projects. Make sound and timely decisions based on project priorities.
- Provide input to departmental management towards making strategic & functional decisions.
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.