Senior Manager, QC Microbiology

Corden Pharma - A Full-Service CDMO

. Provide direct leadership and management for the Quality Control Microbiology Department .

Posted 10/31/2026full-timeBoulder • Colorado • United StatesSenior💰 $145,000 - $165,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality Control Microbiology, including laboratory management, compliance with FDA and ISO standards, and development of contamination control strategies. Proven ability to lead teams, drive continuous improvement, and maintain high-performance laboratory systems.

Highest-signal resume keywords

Quality Control Microbiology Laboratory ExperienceGMP Understanding and ComplianceMicrobiological Techniques and Analytical MethodsProject Management SkillsLeadership and Mentoring Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Microbiological IDs and InterpretationContamination Control StrategiesRoutine Monitoring and Release TestingAnalytical Problem-SolvingData Quality MonitoringEnvironmental Monitoring ProgramsLaboratory Equipment MaintenanceStatistical TechniquesRisk Assessment ParticipationSOP Development

Soft Skills

Strong Written and Verbal CommunicationInfluencing and Negotiation SkillsTeam CollaborationAttention to DetailCoaching and Mentoring

Tools & Technologies

LIMSSAPSharePointLaboratory EquipmentClean Utilities

Industry Keywords

Pharmaceutical MicrobiologyCGMPFDA GuidelinesISO StandardsAnnex 1 Compliance

About the role

Key responsibilities & impact

Provide direct leadership and management for the Quality Control Microbiology Department
Develop employees; plan, assign, and direct work; meet goals and performance standards; and drive continuous improvement
Create and maintain an industry-best QC Microbiology laboratory
Ensure Quality Control services meet compliance and performance expectations
Maintain systems supporting efficient flow of materials and services
Represent the highest level of GMP understanding and accomplishment
Recommend and implement improvements in systems and resource deployment
Monitor international and customer compliance expectations and implement systems to meet them
Interface with Analytical Research and Corden counterparts
Manage shared resources with the manager of Analytical Research
Maintain Quality Control systems including laboratories, LIMS, SAP, inventory control, and SharePoint
Develop or enhance programs for environmental monitoring, GMP cleaning of graded rooms, gowning, water systems, and contamination control
Mentor and develop a team of Microbiologists
Monitor data quality and accuracy
Maintain laboratory equipment performance, standards, procedures, instrument certification, service, repair, and replacement
Monitor workload and adjust operations or staffing for productivity
Counsel, discipline, plan, monitor, and appraise laboratory staff
Drive continuous improvement and benchmark system improvements and resource deployment
Serve as QC Microbiology point of contact for internal and external customers and regulatory agencies
Procure services and materials at optimum cost
Maintain and improve QC compliance systems, including SOPs, calibrations, training, product approval/release, and related processes
Use metrics and work plans to track and improve performance
Ensure safe work practices and proper management of hazardous and non-hazardous waste
Monitor international regulations and implement systems for changing requirements
Facilitate team processes and provide development opportunities
Attend client meetings and serve as the primary expert on microbiological requirements
Manage QC Microbiology staff and directly supervise 10 to 15 employees
Assist with deviation investigations and CAPAs
Assist with gowning qualifications
Train others on microbiological concepts

Requirements

What you’ll need

Bachelor's Degree (BA) from 4-year college or university; more than 10 years of Pharmaceutical Microbiological Quality Control experience; or equivalent combination of education and experience
QC Microbiology Laboratory experience required, including Commissioning of Classified Spaces, Clean Utilities, Routine Monitoring, Release and Stability testing, Microbiological IDs and interpretation
Deep understanding of microbiological techniques, analytical methods, and associated equipment
Experience contributing to or creating contamination control strategies based on Annex 1 requirements
Understanding of FDA guidelines, ISO standards, Annex 1, and other regulatory requirements related to microbiology
Demonstrated expertise in organizing, maintaining, and improving lab systems
Strong written and verbal communication skills
Strong influencing and negotiation skills, and computer skills
Ability to analyze manufacturing requirements and translate requirements to strategies
Understanding of the basic science and engineering associated with pharmaceutical manufacturing
Project management skills, including planning, staffing, organizing, directing, and controlling
Analytical problem-solving skills
Leadership, negotiation, coaching, and mentoring skills
Ability to build relationships, influence, and motivate others
Ability to achieve results through positive direction of others
Experience dealing with technical personnel at corporate and customer levels
Ability to independently or collaboratively create microbiological programs
Ability to lead or participate in risk assessments
Understanding of FDA, ICH Q7, ISO, Annex 1, cGMP, and other regulatory requirements
Ability to work closely with team members toward a common goal
Attention to detail
Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, and governmental regulations
Ability to write reports, business correspondence, and procedure manuals
Ability to present information and respond to questions from managers, clients, customers, and the public
Ability to apply advanced mathematical concepts and statistical techniques
Ability to solve practical problems and interpret written, oral, diagram, or schedule-based instructions
Ability to occasionally lift and/or move up to 50 pounds

Benefits

Comp & perks

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance