Astellas Pharma Manager, Quality Control Analytical in Westborough, Massachusetts
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
Astellas is announcing a Manager, Quality Control Analytical opportunity.
The Manager of Quality Control plays a key role in managing QC product testing operations and Method Validation functions in support of AIRM's program goals and regulatory submissions. . Looking for experience with Cell Culture, RT-qPCR, Flow Cytometry and Cell based assays of cell therapy products.
Essential Job Responsibilities:
Responsible for overall day-to-day work operations in the QC Analytical lab; in-house and external product testing across product lines, associated support lab functions, and ensures documentation completed in accordance with cGMPs.
Manage and perform in-process, release and stability testing of AIRM cell therapy clinical products and cell banks internally and at contract testing labs.
Partners with analytical development to achieve method readiness to initiate validation, write validation protocol, gather and interprete data generated by analytical development/QC labs and writes/reviews validation reports.
Participates in execution of method validations and transfers within and outside of AIRM.
Interacting with contract laboratories to support sample testing, data analysis and investigations as required.
Oversees QC equipment validation, maintenance and calibration, and QC laboratory scheduling and maintenance.
Establish personal and QC analytical group goals to meet deliverables based on issued objectives.
Author and approve SOP's, protocols, reports, data summaries and quality systems internally as well as at CROs and CMOs.
Monitor and trend QC data; complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stability testing.
Manage and train junior members of the QC Analytical team on analytical methods, cell culture techniques, GDP and GMP best practices.
Expertise in analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other new technologies used for the testing of cell therapy products.
Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures with appropriate root cause anlysis. Provide updates to Tech Ops management as needed.
Collaborate with regulatory to support IND/NDA/MAA filings/amendments on CMC sections.
Support regulatory PAI and GMP inspections in a global environment.
Implement GMP systems in QC and ensure compliance with documented policies.
This position interacts with all levels of management on a routine basis and will oversee the QC Analytical operations. Works on complex and diverse problems giving guidance and suggestions. Actions may have implications on operations, budget and/or credibility.
Reports to the next line manager
PhD, MS or BS in Molecular Biology, Chemistry, Pharmaceutical Sciences, Life Sciences or equivalent; PhD preferred.
PhD 3+ years, MS +7 years or BS +10 years of relevant experience in QC or equivalent experience in commercial pharmaceutical or cell therapy.
Excellent knowledge of GMP, ICH, USP and global compendial regulations and guidance.
QC experience in the biotech and/or pharmaceutical industry
Individuals experienced in cell culture, RT-qPCR, Immunofluorescence, Flow Cytometry and cell based assays preferred.
Possesses a positive, can-do attitude and creatively solves problems.
Occasional weekend work/support may be required to support GMP operations
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Research and Development
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans