The Quality Control Microbiology Manager 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
SkillsData Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations
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