Takeda Pharmaceuticals
Scientist – Analytical Development (AD) – Late Development
Takeda Pharmaceuticals, Boston, Massachusetts, us, 02298
Job Description
Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a 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. As part of the Analytical Development team, you will report to Associate Director, Analytical Development.How you will contribute:
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.Contribute to complex/multiple projects or functional areas through leading or influencing others.Influence and support initiatives related to driving scientific and technical improvement within a function and potentially 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.Significant 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.Identify topics for initiatives and may lead local/global initiatives as directed by senior management.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 8+ years relevant industry experienceMasters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 6+ years relevant industry experiencePhD in chemistry, biology, pharmacy, engineering or related pharmaceutical scienceExperience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP'sSound knowledge of current Good Manufacturing Practices (cGMP)Experience with the use of contract facilitiesExperience contributing to regulatory filingsHave developed expertise in multiple areas of analytical technology and demonstrate an in-depth working knowledge of program strategy. Experienced with working on late-stage assets and with various regulatory agenciesKnowledge of analytical techniques with advanced experience in multiple techniques such as LC, GC, MS, dissolution, particle size analysis, etc.; Able to work in a lab setting and independently interpret results of complex experiments and integrate data produced by other disciplinesExperience with a variety of method development, validation, and transfer; Ability to design and direct analytical strategy to meet CMC project objectivesAble to coordinate resources (internal/external) to support a projectExperience with analytical testing for liposome or LNP or other complex formulations preferredAble 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 endeavorsAbility 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 useDemonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events preferredMore about us: 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.Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
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Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a 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. As part of the Analytical Development team, you will report to Associate Director, Analytical Development.How you will contribute:
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.Contribute to complex/multiple projects or functional areas through leading or influencing others.Influence and support initiatives related to driving scientific and technical improvement within a function and potentially 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.Significant 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.Identify topics for initiatives and may lead local/global initiatives as directed by senior management.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 8+ years relevant industry experienceMasters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 6+ years relevant industry experiencePhD in chemistry, biology, pharmacy, engineering or related pharmaceutical scienceExperience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP'sSound knowledge of current Good Manufacturing Practices (cGMP)Experience with the use of contract facilitiesExperience contributing to regulatory filingsHave developed expertise in multiple areas of analytical technology and demonstrate an in-depth working knowledge of program strategy. Experienced with working on late-stage assets and with various regulatory agenciesKnowledge of analytical techniques with advanced experience in multiple techniques such as LC, GC, MS, dissolution, particle size analysis, etc.; Able to work in a lab setting and independently interpret results of complex experiments and integrate data produced by other disciplinesExperience with a variety of method development, validation, and transfer; Ability to design and direct analytical strategy to meet CMC project objectivesAble to coordinate resources (internal/external) to support a projectExperience with analytical testing for liposome or LNP or other complex formulations preferredAble 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 endeavorsAbility 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 useDemonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events preferredMore about us: 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.Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
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