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Sr. Manager, QC Microbiology

Employer
Hired by Matrix, Inc
Location
Exton, Pennsylvania, US
Salary
Competitive
Closing date
Jan 30, 2022

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Statistics, Biology
Salary Type
Salary
Employment Type
Full time
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Job Description: Manage the Microbiology laboratory operations on a daily basis in the Biologics Pilot Plant.
Oversee microbiological related testing of in-process samples, final product testing, critical utilities sampling and testing, validation and requalification support, incoming component testing, and microbiological identification in the biologics pilot plant, in support of commercial and clinical product manufacturing.
Sampling and testing must meet or exceed ICH, FDA, PMDA, EMA, and other governmental regulations or guidelines.
Oversee all raw material and final product (BDS and antibody drug intermediate (ADI)) testing conducted at contract laboratories.
Responsible to act as the functional subject matter expert during regulatory inspections.
Leads, develops and mentors staff at a variety of levels.
Provides leadership, management, and delivery of compliant laboratory data in support of clinical and commercial material manufactured in the Biologics Pilot Plant, in accordance with appropriate regulatory, corporate and scientific guidelines.

Essential Functions: Manage Daily operations of the QC Microbiology laboratory, to ensure adherence of sampling and testing operations to cGMP (including data integrity), ICH, FDA, EMA and PMDA regulations and Guidelines, industry standards, and OSHA requirements. Oversee internal microbiological testing for product, raw materials, critical utilities, and environment. Monitor sample collection, testing, and data review. Provide routine trend analysis and reports to upper management.

Validation and requalification support.
Oversee all external testing for raw materials and BDS / ADI performed at contract laboratories. Monitor sample collection, testing, and data review.
Manage, recruit, train, and develop staff supporting operations. Ensure staff are trained in specific job knowledge, equipment operation, and relevant regulations. Provide supervision and hands-on support of laboratory staff in the operation of equipment and assays to support operations. Coordinate maintenance, calibration, and validation with appropriate internal departments.
Conduct and manage laboratory investigations and participates as QC representative during investigations into deviations/exceptions as required. Provide timely reporting, investigation, and resolution of deviations, change control, and corrective and preventive actions.
Interact cross-functionally with Upstream and Downstream Operations, Support Operations, Facilities, QA, QC Biochemistry, Validation, and other internal and external functions to support successful product development and commercial / commercialization activities.
Plan and implement process improvement and cost reduction activities at the departmental and inter-functional level. Develop and oversee facility-wide programs to help ensure product quality.
Development and management of SOPs, forms, and methods required to support the compliant operation and testing conducted in the Microbiology laboratory.
Ability to lead and maintain the development of Microbiology laboratory testing data and trending.
Scheduling of Microbiology laboratory personnel within the department to meet the Manufacturing schedule and needs.

Requirements: BS/BA in Microbiology, or other relevant scientific discipline required.
A minimum of 8 years' working experience in a cGMP Quality Control department within an FDA-regulated industry required.
Minimum 3 years' direct supervisory experience required.
Experience with aseptic processing or bioprocessing is required.
Advanced data integrity knowledge and practices. Intermediate understanding of statistics, control charts, action and alert limits.
Thorough knowledge of cGMP/ICH/FDA regulations.
Intermediate knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PPQ, etc.
Experience with inspections/audits by the FDA or other similar regulatory agencies.
Ability to prioritize and successfully manage complex and competing projects.
Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision- making skills.
Must be team-oriented and has the demonstrated ability to work cross-departmentally throughout the manufacturing site.
Demonstrated resource management and planning skills. Must be flexible, adaptable, and able to work under pressure while meeting designated timelines.
Excellent oral and written skills.
Experience with LIMS preferred.
Physical requirements: Limited handling of laboratory equipment, chemicals, and biological material.

Please submit your resume for consideration. Once submitted, feel free to contact Shweta at
(201) 535 - 3603 for additional information.

Approx. Duration: 4 months

About Hired by Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full-service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option with a company match after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified

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Hired by Matrix Career Center: https://www.hiredbymatrix.com/find-work/open-positions/
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