Manager - Bioanalytical Operations Support応募後で応募 求人ID R0068849 掲載日 06/09/2022 Location:Cambridge, Massachusetts
MANAGER - BIOANALYTICAL SUPPORT OPERATIONS
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Manager - Bioanalytical Support Operations in our Cambridge office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- Coordinate Regulated (GLP) and Non- GLP nonclinical discovery or development studies at in-house or at Contract Research Organizations (CROs)
- Review study-related documents (scope of Works, protocols) for completeness, accuracy and consistency
- Perform and document CRO site visits to monitor study performance
- Coordinate activities and collaborating with multiple functional groups (i.e. Pharmaceutical Sciences, DMPK, and QA, etc.) across Global- Takeda
- Support PTS laboratories
- Provide scientific and technical support in the areas of outsourced scientific study management. The candidate is expected to contribute in the following areas: Support assay transfers, qualifications, and method validations for various assay platforms (i.e. Mass spec, LBA, ADA, qPCR, cell-based assay, etc.).
- Coordinate test material shipments, CRO communications including set up of applicable meetings
- Schedule, track, and monitor study progress for discovery or development programs
- Schedule milestones of study activities as well as corresponding reports or data from internal and external laboratories
- Track reporting deliverables, graph real-time data or upload data to appropriate database and maintaining information on Compound Profiling request
- Maintain study correspondence for assigned studies
- Ensure finalization of study reports to support regulatory submissions
- Responsible for outsourcing of in vitro screening studies, communicating results to project teams and uploading data into corporate database
- Assist with management of vendors
- Work closely with Operations Lead at other Takeda sites to streamline work process across sites
- Support outsourced research activities for Development team
EDUCATION, BEHAVORIAL COMPETENCIES AND SKILLS
- BS desirable, in a scientific discipline and/or 5+ years of industry experience, working at a pharmaceutical company and/or CRO
- Working knowledge of FDA Good Laboratory Practice (GLP) Regulations as set forth in 21 CFR Part 58, Bioanalytical Method Validation Guidance for Industry May 20158, OECD and ICH guidelines
- Experience with the design and conduct of regulated nonclinical studies
- Experience in reviewing study data and reports
- Ability to effectively communicate both internally and externally in performing role as liaison between Takeda and CRO
- Proficiency with Microsoft Word, Microsoft Excel, and other common electronic systems
- AALAS certification desirable
- Ability to travel domestically and internationally, 5%-20%
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
No Phone Calls or Recruiters
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.