Senior Microbiologist (Temp)

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

The Experience

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

Your Role

We are hiring a W2-Temp Senior Microbiologist in York, PA. The ideal candidate will have a strong background in microbiological testing, with specific expertise in disinfectant efficacy testing, environmental monitoring, and cGMP compliance.

Design, execute, and interpret disinfectant efficacy studies.

Perform routine microbiological testing including endotoxin, bioburden, microbial identification, microbial limits testing, sterility testing, media growth promotion, environmental monitoring, and critical utilities collection and testing.

Conduct and oversee environmental monitoring including viable air and surface sampling, non-viable particle monitoring, etc.

Perform trending and data analysis with appropriate statistical evaluation of environmental monitoring.

Perform and lead investigations for environmental monitoring excursions and incidents during aseptic filling routine monitoring.

Perform and lead required risk assessments and investigations of microbiological deviations and out-of-specification (OOS) results.

Write, review, and approve standard operating procedures and coordinate/execute method development and method validation.

Document all activities in accordance with Good Documentation Practices.

Support the QC Microbiology group in internal audits, external client audits, and global regulatory audits as needed.

Coordinate and assist in the validation, calibration, and maintenance of laboratory instrumentation and equipment.

Maintain laboratory supplies, equipment calibration, and cleanliness.

Adhere to all safety and compliance protocols.

Additional responsibilities as assigned.

Requirements

Bachelor’s or Master’s degree in Microbiology, Biology, or related field.

7-10 years of experience in QC Microbiology function within the pharmaceutical manufacturing industry.

Experienced in designing, executing, and interpreting disinfectant efficacy studies.

Experience with microbial identification methods .

Prior experience in aseptic manufacturing environment with strong knowledge of aseptic technique, processes, and compliance.

Advanced understanding of industry regulations and compliance.

Experience with disinfectant efficacy studies and facility validation is highly preferred.

Experiene working in biosafety cabinets.

Excellent communication skills, both verbal and written.

Strong attention to detail and organizational skills.

Excellent analytical and problem-solving skills.

Ability to work both independently and collaboratively in a team setting.

Benefits

This a W2-Temp position with potential extension. W2-Temp positions include medical benefits and sick time benefits.

Equal Opportunity Employment Statement

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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