Manager, Microbiology Lab

Page Mechanical Group, Inc.; Pennsylvania; On-site; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company as a Microbiology Lab Manager, where you will lead a dedicated team in ensuring the highest standards of quality and compliance. This pivotal role involves overseeing daily lab operations, collaborating with stakeholders, and supporting new product launches through meticulous testing and validation. With a focus on regulatory adherence and continuous improvement, you will play a crucial part in maintaining microbial control standards and enhancing laboratory productivity. If you are passionate about microbiology and ready to make a significant impact in a dynamic environment, this opportunity is perfect for you.

Benefits

Competitive Salary Package

401(k) Retirement Plan

Vested Company Match Contribution

Paid Time Off

Health Savings Account

Life Insurance with Optional Supplemental Plan

Short-Term Paid Disability

Health Advocacy Programs

Qualifications

• 5+ years of management experience in Quality Control microbiology.
• Strong knowledge of cGMP, ICH, FDA and compendial guidance.

Responsibilities

• Manage daily operations of the Microbiology Lab and lead a team of microbiologists.
• Ensure compliance with regulatory requirements and perform routine audits.
• Develop training programs and improve laboratory productivity.

Skills

Microbiology

cGMP

Quality Control

Analytical Skills

Regulatory Compliance

Leadership

Problem Solving

Environmental Monitoring

Technical Communication

Laboratory Safety

Education

Bachelor’s degree in Microbiology

Management experience in pharmaceutical industry

Tools

LIMS

TrackWise

Microsoft Outlook

Microsoft Excel

Job description

Manager, Microbiology Lab, Full-Time

Accupac is hiring for a full-time Microbiology Lab Manager to join our Mainland, PA team.

Job Summary:

The Manager, Microbiology Lab is responsible for managing all activities associated with the daily operations of the Microbiology Lab by leading a group of microbiologists. This role is responsible for effectively collaborating with multiple stakeholders to ensure Industrial Plant Hygiene, establishing, and publishing periodic reports on environmental monitoring and trending. This role will also support new product launches by reviewing product specifications, test methodology and providing guidance in test method verification and validation.

The Manager, Microbiology will have strong leadership and substantial experience in supporting the sites to be compliant with regulatory requirements in microbial control standards and procedures. This position will also play a critical role as SME in assisting audits.

Benefits

We believe our most valued resource is the people we work with. Most of our positions offer the following employee benefits:

• Competitive Salary Package
• 401(k) Retirement Plan
• Vested Company Match Contribution
• Paid Time Off
• Health Savings Account
• Life Insurance with Optional Supplemental Plan
• Short-Term Paid Disability
• Health Advocacy Programs

Essential Duties and Responsibilities include but are not limited to the following:

• Assure testing priorities to support Manufacturing and Customer Service
• Establish and implement appropriate training programs for the sites to provide micro awareness and coaching.
• Perform regular GEMBA style assessments of the sites and perform routine audits of the manufacturing areas.
• Ensure data integrity and ensure GDP and GLP in the microbiology laboratory.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity, ability to recognize time sensitivity.
• Demonstrates strong knowledge of cGMP, ICH, FDA and compendial (USP, EP, JP) guidance.
• Strong knowledge of microbiological test methodology, environmental monitoring and industry standard investigation process of any OOS that are related to microbial contamination.
• Reviews and provides oversight for microbial testing performed at contract labs.
• Extremely detail-oriented with strong analytical, verbal, and written communication skills.
• High level of ownership and accountability with strong ability of problem solving.
• Ensure test failures are investigated and documented as per regulatory guidance.
• Ensure implementation of effective CAPA based on root cause analysis.
• Prepare justification for new lab equipment. Prepare purchase orders and coordinate authorization and procurement. Arrange installation and qualification.
• Resolve test method issues which may involve interaction with customer and provide expert opinion.
• Evaluate time and cost aspects of laboratory work associated with new product launch or new testing requirements.
• Provide microbiological technical support to validation projects.
• Ensure calibrations of lab equipment, documentation in logbooks and other GMP compliance activities are performed in the laboratory.
• Develop and implement ways to improve laboratory productivity, cost control and output.
• Review and approve SOP’s, specifications, and other documentation required to administer the laboratory.
• Perform other duties as assigned.

Minimum Requirements of the Job:

• Experience in pharmaceutical product testing / Microbiology.
• Knowledge and experience with Total Quality Management and other quality management philosophies.
• Thorough understanding of Compendial test methodology applicable to microbiology.
• Fluency in written and spoken English.
• Familiarity with LIMS and TrackWise.
• Ability to use computer applications like Microsoft Outlook, Excel etc.
• Ability to manage many diverse tasks and issues simultaneously, through prioritization, delegation, and “hands-on” personal effort in a fast-paced, high-volume environment.
• Understanding of laboratory safety requirements and the MSDS system.
• Ability to read, comprehend, and interpret technical data.
• Ability to represent Accupac to customers and regulatory agencies.

Physical Requirements:

• Sitting for 40 - 50% of the work day.
• Walking/standing up to six hours each work day.
• Hear/Execute clear speech, in person and over the telephone.
• Lift/Carry items up to 40 pounds.
• Hear phones ring, alarms sound through ambient noise and everyday conversation.
• Possess color vision.

Supervisory Responsibilities:

Yes; Microbiologist

Travel:

None

Education and/or Experience:

Bachelor’s degree in a relevant discipline (Microbiology preferred). Minimum of five years management experience in the pharmaceutical industry within a Quality Control microbiology role.

About Accupac

Accupac is a global contract development and manufacturing partner for beauty, personal care and healthcare brands. We develop and manufacture some of the world’s greatest products for global CPGs, emerging Indie brands, and everything in between. We make products that make a difference because we care about bettering the lives of people and the health of our planet.