QC Manager, Microbiology
Company: Astellas Pharma US, Inc.
Posted on: May 14, 2022
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
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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
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medical needs and conducting our business with ethics and integrity
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For more information on Astellas, please visit our website at .
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. Purpose: 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
- Monitor and trend EM data and update management on
environmental trends. Implement corrective action plans when
- 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
- Implement GMP systems in QC and ensure compliance with
documented policies. Quantitative Dimensions: 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 Organizational Context: Reports to the next level line
manager Qualifications: Required:
- PhD, MS or BS in Microbiology or equivalent; PhD
- PhD 3-5 years, MS 7+ or BS with 10+ years of relevant
experience in QC or equivalent experience in commercial
- 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
- Previous superviosory experience in Quality Control
- 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
- Occasional weekend work/support may be required to support GMP
- 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
- 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
Keywords: Astellas Pharma US, Inc., Worcester , QC Manager, Microbiology, Executive , Westborough, Massachusetts
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