Senior Development Scientist, Biologics Drug Product Development
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Senior Development Scientist, Biologics Drug Product DevelopmentApply Now
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 a Senior Scientist, Drug Product Development in our Lexington office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.
The Senior Scientist will be involved in the pharmaceutical development of Takeda’s biologics products (including mAbs, recombinant proteins, peptides, and ADCs). Responsibilities include development of robust formulation for drug substance and drug product throughout their product lifecycle as well as development/tech transfer of scalable and robust drug product manufacturing process from early phase to process validation. The individual will provide leadership and technical guidance for formulation and drug product development efforts, author technical protocols, design and implement experimentation, generate technical reports, and author related CMC sections to support regulatory submissions.
The Senior Scientist will closely collaborate with cross-functional Process Development and CMC team members including technical services, drug substance process development, analytical development, quality control, quality assurance, and supplier relationship and manufacturing leads. The individual will also interface with external contract organizations as required. The individual should proactively identify potential issues, develop effective solutions to technical challenges, and influence stakeholders across the development organization in order to keep projects on schedule.
The role and responsibilities are to:
- Provide technical leadership in execution of biologics product formulation development
- Provide technical leadership for clinical drug product process development / engineering and clinical drug product manufacturing support
- Author/review development documents and support regulatory submissions and responses
- Represent drug product development within cross functional project teams, organizational initiatives, and technology development groups
- Identify, evaluate, adopt and develop formulation and drug product technologies to continuously improve business processes and product development capabilities
- Design and execute phase-appropriate DP formulation development, process development, process characterization, and process validation studies.
- Support drug product manufacturing deviation investigations, CAPAs, and change control management.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Required Education and Experience:
- Bachelor’s degree in chemistry/biochemistry, biology, pharmacy, engineering or related pharmaceutical science and 11+ years relevant industry experience.
- Master’s degree in chemistry/biochemistry, biology, pharmacy, engineering or related pharmaceutical science; 9+ years relevant industry experience.
- Ph.D. in chemistry/biochemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience.
- Sound knowledge of current Good Manufacturing Practices (cGMP).
- Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients (API) and drug products under cGMP.
- Previous experience with the use of contract facilities.
- Experience in working in a multi-disciplinary team environment.
- Previous experience contributing to regulatory filings.
KNOWLEDGE AND SKILLS:
- Protein formulation development experience preferred.
- Experience with analytical methods used for protein analysis such as HPLC, CE, spectroscopy, and sub-visible particle analysis.
- Knowledgeable about Design of Experiments and statistical principles for experimental design and data analysis.
- Exposure to the development of combination products and drug antibody conjugates preferred.
- Experience leading technology transfer to aseptic drug product manufacturers.
- Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions.
- Teamwork - Ability to work well in highly cross functional team environment and across global line functions.
- 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 issues to supervisor; technical writing skills to support authorship of internal technical documents.
- Organizational Skills – Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously.
- Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use.
- Resource Management - Ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors).
- External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events.
- Technical - Subject matter expertise and knowledge of applicable lab equipment and operations.
- 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 10 - 20% 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
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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.
Job ID SR0049242
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