Sr. Manager, Analytical Development Job in New Jersey (NJ), Career, Jobs in Taiho Oncology
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Life Science Career Fair

Sr. Manager, Analytical Development job in Princeton

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Taiho Oncology jobs
New Jersey (NJ), Princeton
Job Code:  2954
Employer:  Taiho Oncology

Location
Country:  United States
State:  New Jersey (NJ)
City:  Princeton
04/23/2024

Description
Sr. Manager, Analytical Development

Princeton, NJ, USA Req #362

Monday, April 22, 2024

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our "People first" approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.

Hybrid

Employee Value Proposition:

Join our team at Taiho Oncology where innovation thrives, and excellence is celebrated. As a Senior Manager in Analytical Development, you'll play a pivotal role in driving scientific breakthroughs and shaping the future of our industry. At Taiho, we prioritize collaboration, creativity, and continuous learning, providing you with the resources and support you need to excel in your role. With competitive compensation, a supportive work culture, and opportunities for career growth and advancement, Taiho is more than just a workplace - it's a community of passionate professionals dedicated to making a difference. Join us and unlock your full potential as a leader in analytical development.

Position Summary:

The Sr. Manager, Analytical Development is responsible for all aspects of Analytical Development related to drug substance and drug product, serving as analytical lead for assigned projects with the CMC team. Liaises with CMOs to ensure methods are developed and qualified to meet regulatory requirements, interacts with QA/Regulatory/CMC to set specifications, and ensures batches are tested and released to meet project timelines and clinical needs.

Performance Objectives:
  • Serves as analytical lead for drug substance/drug product for a drug development project, accountable for analytical deliverables according to project needs and stage of development.
  • Ensures phase-appropriate methods are developed and validated ahead of batch manufacture and testing through development of drug substance and drug product.
  • Ensures all required analytical testing of drug substances and drug products in clinical development is completed according to agreed timelines.
  • Collaborates with relevant cross functional teams to set product specification and assign shelf life.
  • Performs technical review of batch release and stability data for drug substances, and drug products.
  • Reviews analytical documents data for raw materials and intermediates
  • Collaborates in the preparation and review of analytical methods descriptions, method validation/transfer protocols, and reports.
  • Provides expert input and coordinate the development, qualification/validation, and/or transfer of technically sound analytical methods at global CMOs to meet project timelines.
  • Authors IND/IMPD and NDA analytical sections for drug substance and drug product
  • May perform or plan experiments in an in-house laboratory for development and improvement of analytical methods, such as HPLC, LC-MS, KF, etc.
  • Actively participates with the CMC team in resolution of technical issues, e.g., during process development/validation, manufacturing, and release of clinical trial material.
  • Contributes to initiatives to improve work process quality and efficiency.

Education/Certification Requirements:
  • Bachelor's degree in chemistry, analytical chemistry, or pharmaceutical relevant field

Knowledge, Skills, and Abilities:
  • 10 years relevant experience in the pharmaceutical / analytical R&D environment; Master's degree plus 7 years; or PhD with 5 plus years' experience.
  • Hands-on experience with phase-appropriate analytical method development, validation, and transfer.
  • Thorough knowledge of chemistry and expertise with analytical methodologies for the testing of small molecules
  • Hands-on experience with analytical methods for the testing of small molecules such as HPLC/UPLC, LC-MS, dissolution, Karl Fischer titration, and GC.
  • Superior communication skills for interactions with technical personnel at TOI, TPC and contract facilities, cross-cultural team skills.
  • Work and/or supervise in a laboratory, depending on position level and project needs.
  • Experience with preparation of drug substance and drug product sections of regulatory filing documents.
  • In-depth understanding of ICH, compendial, FDA, cGMP, and CMC guidelines and requirements and industry best practices.
  • Familiarity with drug development process, both drug substance and drug product.
  • Potential to manage junior analytical staff

The pay range for this position at commencement of employment is expected to be between $153,000 - $181,000 annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as PTO, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

#LI-Hybrid

Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com . Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

The incumbent in this position may be required to perform other duties, as assigned.
ref: (2954)
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