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King of Prussia, Pennsylvania, United States · On-site
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King of Prussia, Pennsylvania, United States · On-site
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King of Prussia, Pennsylvania, United States · Remote OK
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King of Prussia, Pennsylvania, United States • On-site
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The Quality Control Microbiology Manager oversees laboratory operations, including bioburden and endotoxin testing, to ensure compliance with cGMP standards. They are responsible for managing staff training, validating new assays, and preparing regulatory documentation for product filings.
Candidates must possess a bachelor's degree and at least 7 years of experience in microbiology within a GxP or FDA-regulated biopharma environment. Additionally, a minimum of 5 years of supervisory or leadership experience is required.
The Quality Control Microbiology Associate Director is responsible for planning and prioritizing resource allocation in Upper Merion Biopharma quality control microbiology laboratory to meet testing requirements for product release, raw material, utility, in-process, etc. Oversee the operation of QC Microbiology area which includes bioburden, endotoxin, and other microbiology testing areas. Responsible for managing training of quality control analysts, transferring assays from the development group, qualifying, and validating new assays and implementing assays to be used for quality control purposes to support manufacturing and marketing of the product. Other functions: conduct laboratory investigations related to product testing, compile reports in support of product filings with the regulatory agencies. Review and release of test results and ensure full cGMP compliance in the laboratory operations. Prepare documents (IND, BLA and MAA) to support regulatory filing.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Responsible for managing training of quality control microbiologist and specialists, transferring assays from development group, qualify and validate new assays and implement assays to be used for quality control purposes to support manufacturing and commercial products.
Work directly with other QC groups to ensure timelines are met for release, technical transfers, stability and in-process testing.
Conduct laboratory investigations related to product testing.
Compile reports in support of product filings with the regulatory agency.
Review and release of test results.
Ensure group compliance with laws, regulations, guidelines, procedures, and practices governing microbiological QC testing, including departmental and corporate standard operating procedures and safety procedures.
Ensure technical and professional growth of QC analysts, encouraging excellence and continuous improvement in their performance.
Collaborate and work effectively within the Quality Control groups as well as other departments.
Represent the quality control department and departmental functions on company projects/committees.
Review, update regulatory documents (IND, EOP2, IMPD), as required.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelors degree
7+ years of experience in microbiology
5+ years of experience of supervisory or leadership skills
7+ years of GxP or FDA regulated environment
7+ years of experience of biopharma
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Master’s degree
Strong interpersonal and leadership skills.
Solid team player able to function within team based organization.
Strong verbal and written communication skills.
Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.
Able to prioritize and decide appropriate course of actions.
Effective at implementing decisions.
Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of microbiological quality functions.
#LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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