Microbiologist

PSC BiotechYork, PA
Onsite

About The Position

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. 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. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At BioTechnique, it’s about more than just a job—it’s about your career and your future.

Requirements

  • Bachelor's degree in Microbiology, Biology, Biotechnology, Biochemistry, or a related scientific discipline
  • 4-6 years experience of Quality Control Microbiology experience within a regulated pharmaceutical, biotechnology, or related industry.
  • Knowledge of microbiological testing methods, environmental monitoring programs, and contamination control principles.
  • Understanding of cGMP regulations, data integrity requirements, and laboratory documentation practices.
  • Strong analytical, problem-solving, organizational, and communication skills.
  • Ability to manage multiple priorities and work effectively in a team environment.
  • Must be authorized to work in the U.S.
  • No C2C at this time.

Nice To Haves

  • Experience with method validation, investigations, and trend analysis preferred.
  • Demonstrated leadership and mentoring capabilities for advanced-level positions.
  • Experience with LIMS, eQMS, or laboratory data systems is preferred.

Responsibilities

  • Perform microbiological testing, sampling, and laboratory analyses in accordance with approved SOPs.
  • Execute Environmental Monitoring (EM) activities, including viable and non-viable air, surface, and personnel monitoring.
  • Perform Disinfectant Efficacy Testing (DET).
  • Experience with bioburden, endotoxin, and related microbiological assays on client samples.
  • Set up, operate, and maintain laboratory equipment and instrumentation.
  • Perform and document method validations, qualifications, and trend analyses.
  • Review, analyze, and accurately document testing results while maintaining data integrity.
  • Report and participate in investigations related to OOS, OOT, and atypical results.
  • Support contamination control, GMP compliance, and laboratory continuous improvement initiatives.
  • Author, review, and execute protocols, reports, and technical documentation.
  • Train, mentor, and provide technical guidance to junior microbiologists and laboratory personnel.
  • Lead complex testing, validation, and laboratory projects.
  • Follow all safety procedures and wear required PPE.

Benefits

  • 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
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