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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 QC Manager, Microbiology opportunity. This position is based in Westborough, Mass. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
The Manager of Quality Control plays a key role in managing QC Microbiology laboratory operations, personnel, microbiology product testing, analytical validation and environmental monitoring program in support of AIRM's program goals and regulatory submissions. Looking for strong experience with environmental monitoring and microbiology assays (endotoxin, bioburden etc) and microbial identification in a QC environment.
Essential Job Responsibilities:
* Oversees overall day-to-day work operations in the QC Microbiology lab; in-house and external product testing across product lines, associated support lab functions, and ensures documentation completed in accordance with cGMPs.
* Oversee the environmental monitoring (EM) program at AIRM and lead alert/action limit excursion investigations.
* Manage a team of QC Microbiology personnel and external contract workers to support GMP manufacturing and QC testing operations.
* Monitor and trend EM data and update management on environmental trends. Implement corrective action plans when necessary.
* Oversee Gowning and Cleaning Programs throughout AIRM.
* Oversee implementation of new programs and qualifications such as Container closure integrity and headspace analyzer testing.
* Oversee and/or Lead implementation of LIMS system and other Rapid Micorbiological Methods (RMMs) in QC.
* Implement endotoxin, bioburden and other microbiology testing at AIRM with required validations.
* 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.
* Participate or lead RCA and other GMP investigations
* Oversees QC equipment validation, maintenance and calibration, and QC laboratory scheduling and maintenance.
* Author and approve SOP's, protocols, reports, data summaries and quality systems internally as well as at CROs and CMOs.
* Perform environmental sampling and testing when needed.
* 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.
* Collaborate with regulatory to support IND/NDA/MAA filings/amendments on CMC sections.
* Support regulatory PAI and GMP audits and 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. Works on complex and diverse problems giving guidance and suggestions. Actions may have implications on operations, budget and/or credibility
Reports to the next level line manager
* PhD, MS or BS in Microbiology or equivalent; PhD preferred.
* PhD 3-5 years, MS 7+ or BS with 10+ years of relevant experience in QC or equivalent experience in commercial pharmaceutical industry.
* Demonstrated successful management of Environmental monitoring, Personnel monitoring in manufacturing suites, Gowning and Aseptic Qualifications and QC Microbiology labs.
* Strong experience in developing Microbiological assays, (Sterility, Mycoplasma, Endotoxin, Morphology, Gram Stain and Microbial Identification) and managing testing by compendial methods.
* Previous superviosory experience in Quality Control preferred.
* QC Microbiology experience performing and validating endotoxin assay and other compendial microbiology methods in the biotech and/or pharmaceutical industry.
* Excellent knowledge of GMP, ICH, USP and global compendial regulations and guidance.
* 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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled