Analytical Compliance Manager

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Job Description

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 an Analytical Compliance Manager where you will serve on a CMC/Pharmaceutical Sciences project team and oversee and coordinate the GMP release and stability of the project. You will also perform technical/GDP review on data supporting the release and stability of drug substances and drug products made by or on behalf of Takeda using validated test methods and in compliance with cGMP regulations. As part of the TMC US team, you will report to Sr TMC Manager.

How you will contribute:

• Prepare documentation and provide support/trouble shooting during QC testing release and stability OOS/ATI/Investigations at vendor sites

• Vendor data management and lead OOS/ATI/Investigations

• Interpret and communicate results and oversee the technical aspects of a project

• Responsible for functional aspects of a project

• Prepare protocols, reports to support GMP product development

• Review, interpret and communicate data internally (e.g., to supervisor, project teams) and prepares technical reports

• Propose and implement resolutions to technical GMP problems/issues

• Participate as team member on GCT project teams and communicates activities from designated functional area to project team

• Help develop project strategy and communicate complex data/decisions within department and cross functionally as necessary

• Support local initiatives as directed by supervisor and participate in global CMC or functional initiatives as appropriate.

• Serve as a technical resource for junior staff and leverage expertise in GMPs as a functional resource/trainer

• Assist more senior managers in project management activities such as data review and electronic data management

• Ensure QC requirements are met over life cycle of assigned clinical project including GMP release, stability, retest period extensions, reference standard requalifications, specification updates, method transfers, and method validations/verifications

• Support vendor audits

Minimum Requirements/Qualifications:

• Associates degree in Chemistry, Biology or equivalent with +7 years relevant industry experience

• Bachelors degree in Chemistry, Biology or equivalent with 5+ years relevant industry experience

• Masters degree in Chemistry, Biology or equivalent with 3+ years relevant industry experience

• 3 years experience in Quality Control and/or Analytical Development

• Small molecule and/or Biologics GMP drug development experience

• Knowledge of GMP principles

• Experience with regulatory submissions (INDs, annual amendments, IMPD, etc.) is desirable

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• 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 and company match of charitable contributions

• Family Planning Support

• Flexible Ways of Working

• Tuition reimbursement

More 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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $91,700 to $131,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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EEO Statement

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time