Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Analytical Engineering Lead, Manufacturing Sciences and Technologies within the Cell Therapy team at our Cambridge office.
Here, everyone matters, and you will be a vital contributor to our inspiring bold mission. As an Analytical Engineering Lead you will be empowered to provide scientific expertise and work with internal stakeholders as well as external partners across multiple functions at Takeda.
The Cell Therapy Pharmaceutical Sciences team in Cambridge, MA, is establishing internal capabilities to manufacture several parallel cell therapy programs for in-human clinical studies. This position s primary role is to provide scientific and technical leadership in bringing these programs to patients, with particular focus on qualification and optimization of analytical methods that will deployed in manufacturing. In this role you will be expected to work within the GMP manufacturing engineering group, working with Development, Technical Operations and Quality to onboard new analytical methods and instrumentation, and engineer them towards robust deployment and implementation in GMP.
- Work cross-functionally with Development, Technical Operations and Quality groups to tech transfer and onboard analytical methods and instrumentation processes into GMP
- Lead analytical method qualification and identify method improvement requirements, with particular emphasis on aspects required for GMP compliance, and define the development/engineering strategy towards mitigating technical gaps, particularly as it regards to in-process controls that need to be executed within the manufacturing suite
- Define, edit and revise Master Batch Records
- Author and execute qualification and validation protocols, working in conjunction with the Technical Operation and especially - Quality groups
- Train operators and act as Manufacturing Analytical Engineering superuser
- Act as Analytical Engineering lead for Deviations, Root Cause Analysis, and CAPAs
- Author and execute Life Cycle Management analytical activities, and define/coordinate the related Change Control Activities
- Assist in the integration and implementation of digital data enterprises, including electronic Batch Record and data systems
- Contribute to and review regulatory documents
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years relevant experience
- Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 9+ years relevant experience
- PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant experience
- Excellent background in immunology, immune-oncology and/or vaccines and ability to apply biological manufacturing/characterization requirements
- Must have 5+ year of industry experience in Cell Therapy development and manufacturing, including 2+ years first-hand experience with GMP requirements, quality assurance and analytical method development.
- Must display advanced knowledge of Cell Therapy-related analytics, including IPCs, release and safety assays. Must be proficient at assays including but not limited to flow cytometry, ELISA, PCR, and in-vitro potency assays.
- Must be familiar with analytical method qualification/validation requirements, as well as with GMP Change Control requirements.
- Prior experience with both internal and external manufacturing (CMOs), with demonstrated Technology Transfer expertise and well as Life Cycle management (analytical method change and change control)
- Must be proficient at utilizing statistical analysis tools (JMP or similar) to drive experimental design and optimization via DoE and similar approaches
- Must have prior experience with technology transfer, batch record editing, as well as training.
- Experience in multidisciplinary clinical projects and teams with ability to integrate cross-functional information.
- Prior experience with translational aspects of IND, NDA or BLA desirable
Knowledge and Skills:
- Technical Skills SME for GMP manufacturing analytical engineering, including method refinement and training.
- Teamwork Skills Demonstrated ability to work well on global cross-functional teams. Experience in operating and executing programs in GMP environments.
- Communication Skills Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents.
- Portfolio Management / Stakeholder Management Demonstrated experience in designing and authoring test plans, qualification studies, as well as experience with leading small teams and training.
- Organization Exercises good time management and prioritization skills to balance multiple project and departmental objectives
- Technical - Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors. Background in GMP manufacturing is required.
- Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use.
- Resource Management - Project management skills; ability to manage one s time within individual, departmental, and corporate goals and timelines; management of internal external resources (vendors)
- Leadership Skills Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.
May require approximately up to 5% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
- Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.