As a key member of the Manufacturing Sciences group,� this individual will be responsible for providing technical and scientific leadership to support commercial and clinical production of biologics including process and product investigations and troubleshooting, continuous process improvement and life-cycle management, technology transfer, and process validation. This individual will lead the upstream manufacturing support lab and contribute as a key member of various cross-functional teams and interact extensively with other departments including Manufacturing, QA, QC, PD, Engineering and RA etc. The main responsibilities will include:
Provide technical leadership to continuous process improvements, aiming at improve robustness, capacity, and productivity Provide technical leadership to investigations supporting routine GMP production Provide support to CMC strategy development Implement new process control strategy including Process and Analytical Technologies (PAT) Lead and mentor junior staff as an in-line or matrix leader.Responsibilities:
Job Function and Description
40%-Leading upstream 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. Significant support for strategy development.
25%-Provide technical expertise and leadership in trouble-shooting and root cause analysis for process discrepancies and quality investigations of complex technical nature
10%-Supporting regulatory inspections and filings as an author and reviewer.
20%-Coaching of Junior Staff members; building a strong technical team
5%Implementation of effective and sustainable process control strategy including new Process and Analytical Technologies(PAT)Education and Experience Requirements
Essential: �This individual will have a minimum of:
- A PhD in Biochemistry/Protein Chemistry, Chemical Engineering or related disciplines with a minimum of 8 years of relevant experience in a biotechnology/pharmaceutical environment; or MS in Biochemistry or Chemical Engineering with a minimum of 10 years of experience is required.
- Proven record of technical leadership.
- Proven ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands.
Key Skills, Abilities, and Competencies
- Hands-on experience in upstream process characterization leading to definition of design space.
- Experience in upstream process development and implementation of process control strategy using QbD principles.
- Experience in implementation of disposables in manufacturing of biologics.
- Experience with application of risk based approach in decision making related to development, characterization and manufacturing of Biologics.
Complexity and Problem Solving
- Have excellent knowledge and experience with biologics process development 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 Takeda's values.
- Have experience in GMP working environments.
- This person will have technical leadership including the ability to influence, motivate, and drive technical rigor.
- Candidate should have experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of the interdependencies of research, technical development, cGMP Manufacturing, Quality, Supply Chain, Preclinical, Clinical, Regulatory and Product Strategy functions. �
- Demonstrate leadership and capability for strategic analysis and issue resolution, organizational and project management skills working in a matrix environment is also required.
- Should possess strong problem solving and risk based decision making skills and a strong ability to influence or manage without direct authority.�
- Highly developed interpersonal skills will be a substantial component of being successful in this demanding role.
The individual will be expected to:
Internal and External Contacts
- Lead process improvement, trouble-shooting and mfg tech supports.
- Identify and analyze complex technical problems and then find and implement solutions.
- Apply fundamental scientific and biological principles to practical technical challenges.
- Independently, plan, design and direct experimental studies to be carried out by his/her direct reports and team members while also encouraging team work and career development.
- Manage multiple work streams and projects. Make sound and timely decisions based on project priorities.
- Provide expert input to departmental and senior management towards making strategic & functional decisions.
- Become the product and process subject matter expert within Biologics Operating Unit and Regulatory CMC.
- Provide significant support to CMC strategy development covering the following aspects:
- Efficient and effective technical support for internal and/or external manufacturing to enable robust supply.
- Implementation of QbD/retrospective QbD.
- Input into and translation of CMC strategy into actionable goals for Manufacturing Sciences.
Other Job Requirements
- Internally, this individual will represent the group to support MFG as a customer with close interactions with the internal business partners including PD, QA, QC, Engineering and RA within Takeda.
- Externally, this individual will interact with vendors who may supply materials or equipment both used in small-scale development laboratory and at-scale MFG.
Notice to Employment / Recruitment Agents:
- Occasional travel may be required.
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 OpportunityShire, 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.EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdfEEO is the Law - Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdfPay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdfReasonable AccommodationsShire, 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.