Senior Scientist

4 weeks ago

Boston, Massachusetts, United States Takeda Full time
About the Role

At Takeda, we are a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a Senior Scientist - Analytical Development, you will provide and drive theoretical/conceptual input to the design, development, and execution of research assignments for a specific project or projects within the functional area to drive efficient progress to early regulatory agency filings.

Your Key Responsibilities
  • Develops project and technical strategy within area of expertise.
  • Develop and leverage strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions across CMC functions and other development functions.
  • Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports within expertise for review.
  • Coordinate transfer of projects as necessary within Takeda or externally.
  • Identify and plan broader technical objectives (project and scientific related) with input from manager as needed.
  • Identify and recommend vendors as appropriate.
  • Coordinate cross-functional teams and resolutions, with a focus on scientific /technical challenges.
  • Contribute to complex/multiple projects or functional areas through leading or influencing others.
  • Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.
  • Review, interpret, and communicate data cross functionally within CMC and project teams.
  • Coordinate others in creating technical reports including reviewing and editing.
  • Conduct analysis of technical and conceptual risk and trends
  • Identify process trends and define process strategy or use of novel technologies.
  • Recognized as a technical expert and resource within function.
  • Significant technical responsibility for a project area/technical program within the department and potentially across CMC (e.g. CMC team AD representative or team lead).
  • Represent functional area on CMC project teams by communicating activities from designated functional area to project team.
  • Integrate scientific/technical efforts around cross-functional issues.
  • Identify topics for initiatives and lead local/global initiatives as directed by senior staff.
  • Ensure a productive and development-rich environment; Serves as a technical resource or mentor for junior staff and uses expertise in laboratory technology as a functional resource/trainer.
  • Define more complex/novel approaches and methodologies to solving complex technical challenges.
  • Identify vendors and build relationships to gain access to technologies as needed to deliver pipeline goals.
  • Manages key vendor relationships across multiple projects as appropriate, and affects resolution of issues arising at vendors.
  • Initiate and influence project direction outside department.
  • Prepare and review technical reports and regulatory filing documentation
Requirements
  • Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years (Sr. Scientist) or 8+ years (Scientist) relevant industry experience
  • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 9+ years (Sr. Scientist) or 6+ years (Scientist) relevant industry experience
  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years (Sr. Scientist) relevant industry experience
  • Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP's
  • Sound knowledge of current Good Manufacturing Practices (cGMP)
  • Previous experience with the use of contract facilities
  • Experience working in a multi-disciplinary team environment
  • Previous experience contributing to regulatory filings
  • 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
  • Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors.
  • Ability to capture knowledge within the organization; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use.
  • Project management skills; ability to manage one's time within individual, departmental, and corporate goals and timelines; management of internal external resources (vendors)
  • Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events preferred (Snr Scientist)
  • Leadership Skills (Sr. Scientist) - Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives
  • Strong knowledge of analytical techniques with advanced experience in multiple techniques such as LC, GC, CE, MS, dissolution, etc.
  • Able to work in lab setting
  • Experience representing Analytical Development in a cross functional CMC environment
  • Proven experience with a variety of method development, validation, and transfer;
  • Ability to design and direct analytical strategy to meet CMC project objectives.
  • Experience in preparing regulatory documentation.
About Takeda

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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