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 Institute of Regenerative Medicine (AIRM)
is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing an Associate Director, QC Microbiology
opportunity at their Astellas Institute of Regenerative Medicine (AIRM)
site in Westborough, MA.Purpose
The Associate Director QC Microbiology plays a key role in managing QC Microbiology laboratory operations, personnel, microbiology product testing, method validation, utilities, and environmental monitoring program in support of AIRM's program goals and regulatory submissions across multiple facilities. Looking for strong experience with implementing LIMS systems, environmental monitoring program, utility monitoring system and hands-on experience with implementing endotoxin, TOC, Conductivity, Bioburden, Sterility testing, CCI testing and microbial identification in a QC GMP environment.Essential Job Responsibilities
- Oversees overall day-to-day work operations in the QC Microbiology laboratories across multiple locations; in-house and external product testing across all AIRM clinical programs, associated support lab functions, and ensures documentation completed in accordance with cGMPs.
- Establish and oversee the environmental monitoring (EM) programs and Utility Monitoring at AIRM facilities. Support manufacturing with APS and APQ reads as per their schedule.
- Establish and Own the facility contamination control program including gowning, facility EM trending and cleaning across AIRM GMP cleanrooms. Lead investigations for any facility contamination and microbial adverse trends.
- Monitor and trend EM and utility data and update management regularly on environmental trends. Implement corrective action plans when necessary. Lead alert/action limit excursion investigations.
- Interacting with contract laboratories and CMO's to support sample testing, data analysis and investigations as required. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stability testing.
- Responsible for ensuring data integrity of all generated quality control data from QC Microbiology laboratory function.
- Oversees QC equipment validation, maintenance, calibration, and QC laboratories scheduling and maintenance.
- Responsible for execution of microbiology analytical method validations and tech transfers within and outside of AIRM.
- Responsible for representing QC to contract labs (Bioreliance, Charles River etc.), AIRM affiliates (Universal Cells, Xypos etc.), CMO's (Minaris etc.) and support any manufacturing tech transfer activities for AIRM programs to meet Tech Ops goals.
- Manage and maintain external team of trained contractors to support AIRM surge of QCM resources and projects.
- Author and approve SOP's, protocols, reports, data summaries and quality systems internally as well as at contract labs and CMOs.
- Implement commercial readiness initiatives and develop audit risk register items to ensure successful regulatory inspections.
- Collaborate with regulatory to support IND/NDA/MAA filings/amendments on CMC sections.
- Support internal audits, regulatory PAI and GMP inspections in a global environment.
- Implement electronic GMP systems in QC and ensure CFR compliance and regulatory guidance's.
- Evaluate new technologies and business processes to identify and execute continuous improvement initiatives at AIRM to ensure commercial GMP readiness.
- Establish personal and QC Microbiology group goals to meet deliverables aligned to objectives.
This position interacts with all levels of management on a routine basis and will oversee the expanded QC Microbiology function. Works on complex and diverse problems giving guidance and suggestions. Actions may have implications on operations, budget and/or credibility.Organizational Context
- Reports to the Director of Quality Control
- PhD, MS or BS in Microbiology or equivalent; PhD preferred.
- PhD +8 years, MS +10 years or BS +15 years of relevant experience in QC or equivalent experience in commercial pharmaceutical industry.
- Demonstrated successful management of Environmental monitoring, Utility Monitoring, Personnel monitoring in manufacturing suites, Gowning and Aseptic Qualifications, QC Microbiology lab set up and GMP audits.
- Strong experience in developing Microbiological assays, (Sterility, Mycoplasma, Endotoxin, Morphology, USP testing (Bioburden, TOC, Conductivity), Gram Stain and Microbial Identification) and managing testing by compendial methods.
- Individuals experienced with implementing environmental monitoring programs and utility systems preferred.
- Individuals experienced with implementing and using LIMS systems.
- Ability/Flexibility to work weekends is required
- Excellent knowledge of GMP, ICH, USP, EU, JP and global compendial regulations and guidance.
- 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 Quality Assurance/Quality Control
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans