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Company

Original Job Post

Takeda · 2 days ago

Senior Scientist - Analytical Development (AD) Synthetic Molecules

Boston, MA

Full-time

Onsite

Senior Level

$133K/yr - $209K/yr

11+ years exp

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Responsibilities

Develop project and technical strategy within area of expertise.

Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports within expertise for review.

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.

Review, interpret, and communicate data cross functionally within CMC and project teams.

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.

Prepare and review technical reports and regulatory filing documentation.

Qualification

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CMC pharmaceutical developmentCGMPRegulatory filingsProject managementAnalytical techniquesMethod developmentValidationRegulatory documentationProblem-solvingCommunicationTeamworkTime managementScientific ResearchLeadershipInterpersonal

Required

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 the 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)

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

Preferred

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