Manager, Microbiology

We provide global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
Summary:
This position is primarily responsible for activities relating to the daily function of the Microbiology laboratory and strategic planning for the lab and lab staff. The individual is the subject matter expert on contamination control and Microbiological testing of parenteral drug products. The individual is heavily involved in customer and regulatory audits, new client interactions, site metrics meetings, site-wide improvement projects, budgeting and data review and interpretation, including protocols, investigations, and lab documentation. This position is responsible for the entire laboratory team, and is required to perform staff management duties such as reviews, disciplinary action, and ensure training is performed. The individual operates with limited supervision and must be able to work both independently and on teams
Essential Duties and Responsibilities:
- Develops multiple processes in the laboratory, scaling up and overseeing the processes, according to cGMP guidelines and ISO 17025 requirements.
- Well versed in all USP microbiological testing, especially USP , , , , .
- Maintains laboratory policy and procedure manuals and assists in developing and writing procedures; validates the procedures and document preparation.
- Develops training and competency programs and procedures; trains new technical staff.
- Oversees laboratory supplies.
- Ensures the environmental testing of the clean-room.
- Leads the monthly Environmental Review Board (ERB) Meeting
- Writes and revises microbiology and other relevant SOP's, as required.
- Provides technical input on product testing issues and instrumentation/equipment.
- Ensures that laboratory is in cGMP compliance conducting inspections of all monitoring systems and equipment.
- Ensure that proper recording and review of data.
- Testing the integrity of raw materials or finished products.
- Conducts and documents OOS and deviation investigations.
- Serves as liaison to service, calibration and technical representative
Supervisory Responsibilities:
Manages two team leads/supervisors and up to 15 employees in the Microbiology Laboratory. Is responsible for the overall direction, coordination, and evaluation of these units. Also directly supervises three non-supervisory employees. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Education and/or Experience:
Degree in Microbiology, preferably advanced.
- Strong organizational skills and ability to prioritize and multi-task in a fast-paced environment. Minimum of 5 years industry experience in a GMP or GLP environment.
- Proficient in the validation/qualification of lab microbiological techniques.
- Previous experience managing a microbiology group.
- Previous experience with pharmaceutical cleanroom environments.
- Skilled in the use of computers and proficient in the use of spreadsheets.
- Knowledgeable in FDA cGMPs (21 CFR 211).
Language Skills:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills:
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Computer Skills:
To perform this job successfully, an individual should have knowledge of Manufacturing software; Spreadsheet software and Word Processing software.
Other Skills and Abilities:
- Facilitate the revision and release of all controlled documents
- Facilitate mandatory reviews of SOPs and month end reports
- Provide oversight for projects to update/maintain official document templates
- Direct and manage the Change Control System
Other Qualifications:
- Must pass background check
- Must pass drug screen
Physical Demands:
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.
Work Environment:
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.
All interested applicants must apply online. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Note
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
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