Job Description
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 n experienced Microbiologist III. This role will lead microbiological testing and environmental monitoring activities to ensure compliance with cGMP and regulatory standards. The ideal candidate will have a strong background in microbiological testing, aseptic technique, and with specific expertise in disinfectant efficacy testing preferred.
- 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.
- Design, execute, and interpret disinfectant efficacy studies.
- 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 is strongly preferred.
- Expereinced in performing critical testing including bioburden, endotoxin, etc.
- Experienced with plating and culturing technique.
- Advacned knowledge of 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.
- Experienced with facility validation is highly preferred.
- Experienced 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 Offering a full suite of benefits, BioTechnique is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
Financial Perks and Discounts
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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Job Tags
Full time, Temporary work, Internship, Local area,