Microbiology Manager
Hays

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience, as well as the geographical location of the position.

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

Our client is seeking a Microbiology Manager in Mahwah, NJ.

Role Description

The Microbiology Manager reports to the Associate Director, Microbiology, and primary responsibilities will be to manage and coordinate staff performing microbiological testing in support of the manufacturing of aseptically processed, terminally sterilized pharmaceutical products and oral solid dosage products. Provides technical leadership, daily oversight and subject expertise as needed to manage the QC microbiology laboratory functions.

• Help in Preparation of OpEx and Capex Budget for the microbiology laboratory. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.

• Take appropriate steps to reduce waste and losses in the analysis process and build improved efficiency.

• Provide day-to-day tactical and logistic support for coordinating execution of activities and/or projects according to timeliness.

• Supervise the testing of in-process, final product and stability samples.

• Review and approve data, procedures and testing in support of batch release

• Anticipate and respond to technical problems, coordinate investigations and help develop appropriate solutions, assuring compliance is maintained and timeliness is met.

• Write, evaluate and approve deviations/ investigations reports

• Supervise, coach and develop staff to ensure all activities are performed and documented according to policies, procedures and consistent with cGMP and regulatory requirements

• Conduct annual reviews for all direct reports and assist in setting performance objectives and developmental plans

• Prepare a laboratory for internal and external audits and participate in internal and external audit as required as SME

• Write, revise and update standard operating procedures as necessary to ensure compliance

• Ensure annual maintenance contact renewal (if any), for calibration of laboratory instruments

• Ensure requalification and calibration of instruments in micro lab as per the schedule

• Order and maintain inventory of the laboratory reagents, media and supplies as necessary to ensure smooth operations

• Procure and qualify new equipment in the laboratory

• Review of change controls, incidents, protocols and deviations of other departments related to microbiology

• Must be able to successfully complete the gown qualification program

• Responsible for microbiology laboratory personnel performance

• Responsible for coordination with Production / R&D/QA/QC for various activities related to the microbiology laboratory

• Interact with different departments in the case of OOT, OOAC, OOAL and OOS observations related to microbiology

• Train and implement cGMP practices related to microbiology in all the manufacturing and related departments

• Stay current with regulatory and compliance requirements for the microbiology laboratory and update SOPs as necessary to ensure compliance

• Suggest continuous improvement of laboratory procedures and practices.

Skills & Requirements

• Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or equivalent required. Master's degree in microbiology or equivalent, preferred

• Requires 5-7 years of experience in the field of Pharmaceutical (formulation facility), pharmaceutical functions of Microbiology and experience of working with an Injectable facility.

• Proven ability to quickly learn and understand complex topics

• Pharmaceutical & FDA/GLP industry experience is preferred over academic laboratory experience

• Microbiology laboratory skills and knowledge, such as aseptic techniques, is required

• Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines

• Superior written and verbal communication skills, with a keen eye for detail

• Proven ability to prioritize and handle multiple projects simultaneously.

• Strong organizational, analytical, troubleshooting and problem-solving skills.

• Ability to analyze details and perform structured decision-making on a daily basis.

• Proven ability to prioritize and handle multiple projects simultaneously.

• Strong organizational, analytical, troubleshooting and problem-solving skills.

• Ability to analyze details and perform structured decision-making on a daily basis.

• Self-starter with a good work ethic and the ability to work independently with minimal supervision and use good judgment, or as a contributing member of a team.

• Excellent verbal and written communication

• Experience handling regulatory audits.

Benefits/Other Compensation

Disability and Life Insurance; Employee Assistance Program; Healthcare Benefits; Incentive and Recognition Programs; Paid Vacation and Holidays; Retirement Benefits; Sick Pay and Medical Leave; Health and Fitness Program.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support from resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'. We also believe that actions speak louder than words. In that regard, we train our staff to ensure inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship for the company. Any qualified applicant or consultant with a disability who requires accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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#1158332 - Joan Francesc Garcia