Quality Control Microbiology Associate Director

About the role

The Quality Control Microbiology Manager is responsible for planning and prioritizing resource allocation in the Upper Merion Biopharma quality control microbiology laboratory to meet testing requirements for product release, raw material, utility, in-process, and other testing needs. The role oversees the operation of the QC Microbiology area, which includes bioburden, endotoxin, and other microbiology testing areas.

Responsibilities

• Manage training of quality control analysts and specialists.
• Transfer assays from the development group, qualify and validate new assays, and implement assays 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 regulatory agencies.
• Review and release test results while ensuring full cGMP compliance in laboratory operations.
• Prepare and update regulatory documents (e.g., IND, EOP2, IMPD, BLA, MAA) to support regulatory filings.
• Ensure compliance with laws, regulations, guidelines, procedures, and practices governing microbiological QC testing, including departmental and corporate SOPs and safety procedures.
• Foster technical and professional growth of QC analysts, encouraging excellence and continuous improvement.
• Collaborate effectively within the Quality Control groups and other departments.
• Represent the quality control department on company projects and committees.

Basic Qualifications

• Bachelor’s degree.
• 7+ years of experience in microbiology.
• 5+ years of supervisory or leadership experience.
• 7+ years of experience in a GxP or FDA-regulated environment.
• 7+ years of experience in the biopharma industry.

Preferred Qualifications

• Master’s degree.
• Strong interpersonal and leadership skills.
• Ability to function effectively as a team player in a team-based organization.
• Strong verbal and written communication skills.
• Ability to interact with peers, subordinates, and senior personnel across multidisciplinary environments, including engineering, facility operations, validation, production, and QA.
• Ability to prioritize and make appropriate decisions.
• Effectiveness at implementing decisions.
• Fully versed in GMPs, NIH, ICH Guidelines, FDA, and other regulatory agency requirements for validation and operations of microbiological quality functions.

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Problem Solving
• Quality Assurance (QA)
• Quality Control (QC)
• Risk Awareness
• Testing Operations