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 Commercial Quality Operations in our Cambridge
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
- 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
- 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
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement
- Tuition reimbursement Company match of charitable
- 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.
Takeda is an EEO
employer of minorities, women, disabled, protected veterans, and considers
qualified applicants with criminal histories in accordance with applicable
laws. For more information, visit
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