Scientist, Medical Chemistry

Company: Takeda Pharmaceutical
Location: Boston
Posted on: February 4, 2025

Job Description:

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Scientist, Analytical Development (AD), Late Stage Development--where you will independently lead efforts in development of analytical methods, implementation of evolving scientific technology and influences strategic planning within AD and across Pharmaceutical Sciences to deliver on program strategy and initiatives. You will also prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports within expertise for review. You will drive analytical strategy as needed by the business and support in-silico and automation initiatives. As part of the Analytical Development team, you will report to Director, Analytical Development.

Develop and leverage analytical 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.
Contribute to complex/multiple projects or functional areas through leading or influencing others.
Influence and support initiatives related to driving scientific and technical improvement both within the analytical function and cross-functionally.
Review, interpret, and communicate data cross functionally within CMC and project teams.
Conduct analysis of technical and conceptual risk and trends.
Technical responsibility for a project area/technical program within the department and potentially across CMC.
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.
Lead local/global initiatives
Ensure a productive and development-rich environment; Serve as a technical resource or mentor for junior staff and leverage expertise in laboratory technology as a functional resource/trainer.
Identify vendors and build relationships to gain access to technologies as needed to deliver pipeline goals.
Manage key vendor relationships across projects as appropriate and affect resolution of issues arising at vendors.
Initiate and influences project direction outside department.
Prepare and review technical reports and regulatory filing documentation.
Coordinate cross-functional teams and resolutions, with a focus on scientific /technical challenges.

Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years (Sr. Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP's
Extensive experience in dissolution method development and strategy, including regulatory interactions, is essential.
Experience with in-silico and automation technology approaches to support program execution.
Knowledge of analytical techniques with advanced experience in multiple techniques for synthetic molecules such as LC, GC, dissolution, KF, particle size analysis, etc.; Able to work in a lab setting and independently interpret results of complex experiments and integrate data produced by other disciplines
In-depth experience with analytical method strategy for dissolution including method development, validation and statistical and modeling approaches preferred.
Experience with method development, validation (phase appropriate and ICH), and transfer; Ability to design and direct analytical strategy to meet CMC project objectives
Able to coordinate resources (internal/external) to support a project
documents issues and/or concerns concisely with colleagues; timely and effectively communicates with senior management; has sound 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
Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events preferred
Experience representing Analytical Development in a cross functional CMC environment
Experience with the use of contract facilities
Experience contributing to regulatory filings
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. --

S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-

Keywords: Takeda Pharmaceutical, Cranston , Scientist, Medical Chemistry, Healthcare , Boston, Rhode Island