Accountable for the technical continuum of analytical methods and strategies from early stage to end of commercial shelf life.
- As an expert in analytical development of biologics, serving as the point of contact on the leadership for analytical control strategy and analytical support for early development stage to commercial biotherapeutics
- Contributes as part of a team of scientists to guide the development of analytical methods/projects from early clinical development through commercialization and life cycle management.
- Providing technical partnership for testing laboratories and process development teams.
- Managing analytical development plan and providing technical justification of product specification.
- Authoring/reviewing regulatory filing CMC analytical sections and responses to health authority questions.
- Owns the analytical control strategy aligned with the Takeda sourcing strategy for a product family - 25 %
- Owns the analytical development plan for a product family - 20 %
- Single point of contact outside of Analytical Development (other PDTS departments, CMC team, Regulatory, MFG, QC and Quality Management PQLs etc.) - 15 %
- Contributes and signs-off on all analytical chapters in IND/IMPD/BLA/MAA (development analytical methods, justification of specifications, impurities, characterization etc) - 10 %
- Represents Takeda Process development biologics and analytical development group at authority meetings and telecom for analytical questions - 10 %
- Ensure a continues information flow between the AD analytical method development, characterization, innovation & PAT, high-thru-put test center - 10 %
- Contribute to develop of an operating model and continuous improvement of platforms based analytical development plans for the complete product life cycle for product families as the company grows - 10 %
Education and Experience Requirements:
- Analytical development expert with extensive experiences on method development, characterization and CMC analytical strategy in biologics development, regulatory agency interaction experiences.
- PhD preferred.
- MS and BS will also be considered depending on relevant experience.
Key Skills, Abilities, and Competencies:
- The following items are essential:
- Direct experience with the analytical support of biologics process development and formulation development, in process testing and characterization
- Knowledge of complex and state-of-the-art methodology for biologics characterization and development of biologic products, including but not limited to, HPLC/UPLC, Mass Spectrometry, immunological methods, cell-based assay, particulates characterization etc.
- Knowledge of ICH and other regulatory guidelines
- Knowledge and experience with product development and clinical supplies processes
- Experience in authoring analytical-related CMC sections of IND/IMPD and BLA/MAA regulatory submissions
- Experience working with Contract Research Laboratories
- Experience in support product life cycle and application of process analytical technology improvements
- The following items are preferred:
- Knowledge and experience with statistical applications for data evaluation
- Knowledge in European, Japanese, Chinese and US CMC regulatory requirements for Biologics
- Strong project management skills with ability to deliver results with effective communication with cross-functional stakeholders
- Strong verbal, presentation, and written communication skills. Can concisely articulate and deliver effective presentations on complex technical issues to non-technical audience
- Ability to create collaborative and trusting relationships internally and with external partners.
Complexity and Problem Solving:
- Demonstrates strategic leadership in the management of analytical development programs, including the in- and out-sourced activities.
- Designs a rational analytical control strategy in keeping with QbD principles
- Documents and reviews data as per established company guidelines and SOPs.
- Authors documents such as protocols, memos, data summaries, reports and procedures and contributes to publications and relevant CMC sections of regulatory filings.
- Presents issues and results at department and project team meetings. Presents at external meetings or publishes in peer-reviewed journals
Internal and External Contacts:
- Communicates effectively and frequently with supervisor, line function and peers.
- Successfully and succinctly conveys complex information in both written and oral forms.
- Networks internally and externally in own area of expertise.
- Act as team or project representative on external collaborations and with contract laboratories.
Other Job Requirements:
- May require travel to health authority meetings
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.