Job Title: Microbiology Manager
Job Description

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 involves effective collaboration with multiple stakeholders to ensure Industrial Plant Hygiene, establishing and publishing periodic reports on environmental monitoring and trending. Additionally, the Manager will support new product launches by reviewing product specifications, test methodologies, and providing guidance in test method verification and validation. The Manager, Microbiology will have strong leadership and substantial experience in ensuring compliance with regulatory requirements in microbial control standards and procedures, and will also play a critical role as a Subject Matter Expert (SME) in assisting audits.

ResponsibilitiesAssure testing priorities to support Manufacturing and Customer ServiceEstablish and implement appropriate training programs for the sites to provide micro awareness and coachingPerform regular GEMBA style assessments of the sites and conduct routine audits of the manufacturing areasEnsure data integrity and compliance with Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) in the microbiology laboratoryEffectively manage multiple priorities involving aggressive timelines at a high level of productivity and recognize time sensitivityDemonstrate strong knowledge of cGMP, ICH, FDA, and compendial (USP, EP, JP) guidancePossess strong knowledge of microbiological test methodology, environmental monitoring, and industry-standard investigation processes related to microbial contaminationReview and provide oversight for microbial testing performed at contract labsProvide microbiological technical support to validation projectsEnsure calibrations of lab equipment, documentation in logbooks, and other GMP compliance activities are performed in the laboratoryEssential SkillsMicrobiologyBiologyMicrobial identificationGEMBAFDA regulationscGMPEnvironmental monitoringUSP guidelinesMicrobial testingAudit processesCAPAInvestigation protocolsValidation protocolsAdditional Skills & QualificationsBS (minimum) degree in relevant discipline (Microbiology preferred)2+ years of management experience in the pharmaceutical industry within a QC microbiology lab5+ years of overall microbiology experienceExperience in pharmaceutical product testing/microbiologyKnowledge and experience with Total Quality Management and other quality management philosophiesWork Environment

The role will involve working in a laboratory setting, adhering to strict regulatory compliance and quality management standards. The environment will require attention to detail, accuracy in documentation, and a commitment to maintaining high standards of data integrity and laboratory practices. The position may involve performing site assessments and audits, requiring a thorough understanding of manufacturing processes and environmental monitoring.

Pay and Benefits

The pay range for this position is $100000.00 - $120000.00

401(k) Plan:
To allow employees to gain a measure of economic security for retirement beyond that provided by you and the Federal Social Security program, Accupac matches 50% of the first 6% contributed to the 401(k). Full vesting is 6 years.
Medical Insurance:
Our goal is to provide a group health plan that gives the employee protection to help meet the cost of hospital and medical expenses for both you and your family (spousal exclusion applies). Benefits are provided through Aetna. All full-time employees are eligible on the first of the month after 60 days of employment. Accupac contributes generously to the premium costs. Below are the employee ontributions over 26 pay periods.
Aetna Medical Plan Options & Pricing:
Aetna High Deductable Plan:
Single ($57.85) / Employee & Child(ren) ($129.04) / Employee & Spouse ($160.54) / Family ($217.03)
Aetna HMO Plan:
Single ($92.54) / Employee & Child(ren) ($194.17 / Employee & Spouse ($234.23) / Family ($320.98)
Aetna POS Plan:
Single ($117.61) / Employee & Child(ren) ($233.79) / Employee & Spouse ($279.33) / Family ($382.09)

Dental Plan:

Workplace Type

This is a fully onsite position in Mainland,PA.

Application Deadline

This position will be accepting applications until Jan 9, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.