As a key member of the Global Biologics Product Stewardship team, this individual will be responsible for providing technical leadership in the production, release and Life Cycle Management activities of primarily multi-site late phase and commercial products. This individual will lead or contribute as a key member of various cross-functional teams focused upon product development and commercial product support. This individual will interact extensively with other departments, including process and formulation development, analytical development, commercial manufacturing, QA, QC, engineering, supply chain, validation, tech transfer, and regulatory functions.
The main purpose of this job is:
- To support the Biologics Operating Unit in the production, release and Life Cycle Management activities of one or several multi-site late phase and commercial biologics.
- Lead or support complex and multi-functional LCM activities (projects, change controls, global initiatives) ensuring the execution of the road map for their implementation.
- Act as a senior subject matter expert (SME) to support the troubleshooting of complex manufacturing and process-related issues
- Drive Knowledge Management across the different facilities, in close collaboration with local TS representative, by defining, leading or supporting harmonization initiatives for the manufacturing processes
- Support the enhancement of product and process knowledge and define and address process gaps through application of QbD best practices
- 10% - Participation in commercial product PDTS sub-teams and act as back-up of CMC Leads in product governance meetings .
- 10 % - Issue regular performance of multi-site products reporting (Product Review Meetings; Dashboards), and support definition of assumptions for manufacturing budget in collaboration with local TS Heads.
- 5% - Co-develop and maintain with the CMC Lead, the Product CMC Roadmap, in alignment with the Product Strategy (P-ONE) .
- 25% - Coordinate lifecycle initiatives and supporting or leading projects in the following areas: Supply Continuity, Risk Management, Line Extensions & Discontinuation, Launch Execution & Global Expansion/Contraction, COGs Management, Regulatory Activities, Product / Process Knowledge, and Capability & Improvement. Responsible for communication of project status and risks to governance bodies, line management, functional areas, and sub-teams.
- 5% - Co-Develop lab study designs, in collaboration with Global Wet Lab Ops, to close development gaps (process characterization), compliance gaps, and develop process improvements.
- 10% - Support business case preparation for process changes as well as alignment for products produced at multiple sites. Drive rigorous assessment of issues and options. Ensure appropriate approval/endorsement of team recommendations and work streams. Drives consensus and timely decision making.
- 5% - Provide technical support for complex process or product impact investigations (e.g. RAPID Response).
- 5% - Ownership for multi-site Product/Process knowledge (commercial Process Description) and for product control strategy. Develop technical trainings and owns the process risk assessments for Biologics.
- 20% - Authorship / review of CMC Regulatory submissions/amendments, RTQs and APQR/annual product reviews.
- 5% - Evaluation of multi-site Process change controls with RA impact.
Education and Experience Requirements:
This individual will have a minimum of:
- A PhD in Biochemistry/Protein Chemistry, Chemical Engineering or related disciplines with a minimum of 10 years of relevant experience in a biotechnology/pharmaceutical environment; or MS with a minimum of 8 years of experience; or BS with a minimum of 10 years of experience is required;
- Proven record of technical leadership
- Proven record of cross-functional influence
- Proven ability to work in a fast-paced environment with demonstrated capacity to manage multiple tasks and demands
- Experience with application of risk-based approaches in decision making
- Experience in risk identification and management
- Experience in process development and characterization leading to definition of design space
- Experience in development and implementation of process control strategy using QbD principles
Key Skills, Abilities, and Competencies:
- Have excellent knowledge and experience with biologics process development and GMP manufacturing support, including cell culture, protein capture and recovery, chromatographic purification, filtration, UF/DF, and drug product formulation, etc.
- Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively.
- Be customer focused, results oriented, science driven and embrace Takeda's values.
- 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 inter-dependencies of research, technical development, GMP Manufacturing, Quality, Supply Chain, Preclinical, Clinical, Regulatory and Product Strategy functions.
- Demonstrated leadership and capability for strategic analysis and issue resolution. Organizational skills working in a matrix environment.
- Ability to make decisions and lead teams in an ambiguous environment
- Strong problem solving and risk based decision making skills and a strong ability to influence or manage without direct authority.
- Highly developed interpersonal skills is a substantial component of being successful in this demanding role.
Complexity and Problem Solving:
- Assess and provide feedback to cross-functional technical proposals and recommendations.
- Identify and analyze complex technical problems and then find and implement solutions.
- Apply fundamental scientific and biological principles to practical technical challenges.
- Manage multiple work streams and projects.
- Make sound and timely decisions based on project priorities. Discern paths forward within ambiguous environments.
- Provide expert input to departmental and senior management towards making strategic and functional decisions.
- Become a product and process subject matter expert within Tech Ops and Regulatory CMC.
- Ensure CMC strategy development delivers on the following:
- Ensure and maintenance of continuous supply of commercial product
- Ensure lifecycle initiatives for products are planned implemented
- Ensure CMC strategy to support regulatory filings for product launch and to enable market expansion
- Ensure plans and implementation to achieve post-marketing and regulatory commitments
- Ensure product and process knowledge is delivered per phase and implementation of QbD best practices
Internal and External Contacts:
- Internally, this individual will represent Tech Ops to governance and have close interaction to global internal business partners including process engineers, manufacturing, QA, QC, engineering, supply chain, validation, tech transfer, and regulatory functions.
- Externally, this individual will interact with CMOs and vendors who are involved in manufacturing.
Other Job Requirements:
- Minimal international travel is expected.
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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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