Sr. Scientist, Analytical Development AD , Late Stage Development

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Join Takeda as a Sr. 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.

How you will contribute:

• 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.

• Coordinate with 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. Expertise in dissolution is preferred.

• 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.

• 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.

• 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.

Minimum Requirements/Qualifications:

• 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

• Experience with late-stage synthetic molecule analytics is required. Additional experience with liposomes, LNPs, peptides and oligonucleotides would be advantageous.

• 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.

• Have developed expertise in multiple areas of analytical technology and demonstrate an in-depth working knowledge of program strategy.

• 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

• Able to expresses oneself 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; 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

• 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

• Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events preferred

• Leadership Skills- Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives

• Experience representing Analytical Development in a cross functional CMC environment

• Sound knowledge of current Good Manufacturing Practices (cGMP)

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