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 categories. 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.
• Transfer assays from the development group, qualify and validate new assays, and implement assays for quality control purposes to support manufacturing and marketing.
• Conduct laboratory investigations related to product testing and compile reports in support of product filings with regulatory agencies.
• Review and release test results while ensuring full cGMP compliance in laboratory operations.
• Prepare documents (IND, BLA, and MAA) to support regulatory filings.
• Work directly with other QC groups to ensure timelines are met for release, technical transfers, stability, and in-process testing.
• Ensure group compliance with laws, regulations, guidelines, procedures, and practices governing microbiological QC testing, including departmental and corporate SOPs and safety procedures.
• Ensure technical and professional growth of QC analysts, encouraging excellence and continuous improvement.
• Collaborate and work effectively within the Quality Control groups and other departments.
• Represent the quality control department and departmental functions on company projects and committees.
• Review and update regulatory documents (IND, EOP2, IMPD) as required.

Basic Qualifications

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

Preferred Qualifications

• Master’s degree
• Strong interpersonal and leadership skills
• Solid team player able to function within a team-based organization
• Strong verbal and written communication skills
• Ability to interact with peers, subordinates, and senior personnel in a multidisciplinary environment, including engineering, facility operations, validation, production, and QA
• Ability to prioritize and decide on appropriate courses of action
• Effective 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