Description:
The Associate Director of Quality Control (QC) Microbiology is responsible for leading and overseeing all microbiological quality control activities supporting the manufacture, testing, release, and stability of biologics products, including monoclonal antibodies, recombinant proteins, and biosimilars within a GMP-regulated CDMO environment. This role provides strategic and operational leadership for environmental monitoring, utility monitoring, microbial testing, rapid microbiological methods, and contamination control programs supporting clinical and commercial manufacturing operations.
The incumbent will ensure compliance with FDA, EMA, MHRA, ICH, USP, and global regulatory expectations while driving continuous improvement, operational excellence, and inspection readiness. This role requires strong technical expertise in microbiology, aseptic manufacturing support, and biologics quality systems. This exciting opening offers the candidate the opportunity to be a part of a professional, customer-focused, pharmaceutical company with a competitive salary and full benefits package.
Zylidac Bio LLC is a leading Contract Development and Manufacturing Organization specializing in the development and manufacturing of biologics, particularly antibodies. We are committed to delivering high-quality products and services that meet the evolving needs of our clients in the biopharmaceutical industry.
Leadership & Management
-
Lead the QC Microbiology organization, including hiring, mentoring, performance management, and professional development of microbiology staff.
-
Develop departmental objectives, KPIs, budgets, and resource planning aligned with company goals.
-
Foster a culture of quality, compliance, accountability, and continuous improvement.
-
Provide technical and strategic leadership during facility expansions, technology transfers, and commercialization activities.
-
Serve as SME for microbiological quality systems during customer audits and regulatory inspections.
QC Microbiology Operations
-
Oversee routine and non-routine microbiological testing including:
-
Environmental Monitoring (EM)
-
Water and utility monitoring
-
Bioburden testing
-
Endotoxin testing
-
Sterility testing
-
Growth promotion testing
-
Microbial identification
-
Aseptic process support
-
Ensure timely review and approval of microbiological data, trends, deviations, CAPAs, OOS/OOT investigations, and laboratory documentation.
-
Maintain contamination control strategies aligned with Annex 1 and current industry expectations.
-
Support batch disposition activities through data review and quality assessments.
-
Ensure laboratory activities comply with GMP, data integrity, and ALCOA+ principles.
Regulatory & Compliance
-
Maintain inspection-ready microbiology laboratory operations in compliance with:
-
FDA
-
EMA
-
ICH
-
USP
-
EU GMP Annex 1
-
21 CFR Part 11
-
Author and review SOPs, protocols, validation reports, risk assessments, and regulatory responses.
-
Lead microbiology support for regulatory submissions, customer inquiries, and audits.
-
Drive improvements in data integrity, quality systems, and laboratory compliance programs.
Technical & Scientific Support
-
Provide expertise in cleanroom qualification, aseptic manufacturing support, and contamination investigations.
-
Evaluate and implement rapid microbiological methods and new technologies where applicable.
-
Support method validation, method transfer, and lifecycle management for microbiological assays.
-
Collaborate closely with Manufacturing, QA, MSAT, Validation, and Engineering to resolve quality and operational issues.
-
Lead root cause investigations involving microbial excursions and contamination events.
Continuous Improvement
-
Identify and implement operational efficiencies, automation opportunities, and best practices.
-
Analyze environmental and utility monitoring trends to proactively identify risks.
-
Support digitalization initiatives, LIMS optimization, and electronic systems implementation.
-
Establish metrics and dashboards for microbiology performance and compliance monitoring.
Requirements:
QUALIFICATIONS – SKILLS & REQUIREMENTS:
Technical Skills
-
Strong knowledge of:
-
Environmental monitoring programs
-
Aseptic processing
-
Sterility assurance
-
Cleanroom operations
-
Utility systems
-
Contamination control strategies
-
USP microbiological methods
-
GMP documentation practices
-
Familiarity with rapid microbiological technologies and automated systems preferred.
-
Experience with LIMS, TrackWise, Empower, MODA, or similar systems desirable.
-
Strong technical writing, investigation, and risk assessment skills.
Core Competencies
-
Strategic leadership
-
Technical problem-solving
-
Regulatory compliance mindset
-
Cross-functional collaboration
-
Decision-making under pressure
-
Strong communication and presentation skills
-
Continuous improvement orientation
-
Customer-focused mindset
Education
-
Bachelor’s degree in Microbiology, Biology, Biochemistry, or related scientific discipline required.
-
Master’s degree or PhD preferred.
Experience
-
10+ years of progressive QC Microbiology or pharmaceutical microbiology experience in biologics, biotechnology, or sterile pharmaceutical manufacturing environments.
-
Minimum 5 years of leadership or people management experience.
-
Strong experience supporting monoclonal antibodies, recombinant proteins, or biosimilar manufacturing preferred.
-
Experience within a CDMO environment strongly preferred.
-
Direct experience supporting regulatory inspections and customer audits required.
Preferred Industry Experience
-
Biologics CDMO operations
-
Monoclonal antibodies (mAbs)
-
Biosimilars
-
Mammalian cell culture manufacturing
-
Sterile injectable products
-
Commercial and late-stage clinical manufacturing
