Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager II, Quality Control on our Oncology and Biologics Commercial Quality team in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager II, Quality Control Commercial Quality Operations working on the Quality Compliance team within Release and Stability Management, you will be empowered to ensure Takeda s products meet all quality standards. A typical day will include:
- Manage oversight of test laboratories at contract manufacturing organizations and contract testing organizations for Oncology & Biologics Commercial products for injectable parenterals and oral solid dose products.
- Generate release COAs and stability reports and conduct and resolve analytical investigations and deviations
- Review and/or provide analytical information for regulatory filings and responses to Health Authorities
- Lead training and on-boarding activities for new QC employees.
- Ensure release and stability study points are performed on time, the testing is compliant, and that test documentation and results are captured in Takeda electronic systems.
- Conduct Out Of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and drive to closure. Collaborate with GMSO (Global Manufacturing Supply Operations) as needed.
- Initiate Deviations, Investigations, Corrective/Preventative Actions (CAPA).
- Initiate Change Controls to change vendor/TPIC specification documents, vendor test methods, stability protocols, and relevant site batch records.
- Generate product trending for all methods and attributes for each product at each assigned site, including ad hoc trending for deviations and investigations.
- Generate performance metrics and participate in audits and inspections by alliance partners and government agencies
- Provide QC representation for regulatory filing team meetings (e.g. Prior Approval Submissions, renewals/updates/supplements, specific LOC requests)
- Author Annual Product Review (APR/PQR) for QC batch release/stability sections.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelors or a Masters degree in Analytical Sciences or Life Sciences.
- Extensive experience in analytical method development, qualification and validation of assays of biologics products.
- Experience with Bioassays and impurity assays such as FACS Binding, Adhesion, HCP and Protein A is a plus.
- 10 + years experience in pharmaceutical or biopharma preferred with at least 2 years of supervisory experience.
- Job related experience in QC specific to release testing review and assessment of deviations/investigations
- Ability to collaborate effectively with various cross-functional groups within the company as well as with external vendors. Experience with companies outside the US
- Computer skills preferably include Word, Excel, Trackwise or electronic document repositories. Experience with SAS JMP a plus
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
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.