INCOG BioPharma Services · 14 hours ago
Associate Microbiologist, 2nd shift
Fishers, IN
Full-time
Onsite
Entry, Mid Level
2+ years expINCOG BioPharma Services is a company focused on building long-term value for their customers in the parenteral injectable drugs sector. The Associate Microbiologist will operate with a Quality Mindset, conducting microbiological testing and supporting quality control processes while fostering cross-functional relationships within the organization.
BiopharmaBiotechnologyManufacturingPharmaceutical
Responsibilities
Play a key role in building and enhancing the QC Microbiology Laboratory team
Conduct testing for sterility, endotoxin, and bioburden on drug products (including APIs, bulk drug products, final intermediate products, and aseptic intermediates), excipients, and in-process materials
Support and refine a comprehensive Environmental and Utilities Monitoring program
Maintain rigorous scientific and quality standards in all work
Adhere to high standards of Good Documentation Practices (GDP) for Good Manufacturing Practice (GMP) testing
Execute microbiological testing to support advanced aseptic drug product manufacturing operations
Use paper-based and automated systems to manage QC policies, procedures, and technical reports across their full lifecycle, including authoring, reviewing, approving, and retiring documents
Review internal documentation with precision, taking personal ownership of departmental data and outputs
Participate effectively and accurately in Quality Events
Support the professional growth and development of QC Microbiology Technicians in the lab
Demonstrate a team-oriented approach, serving as both a project facilitator and active contributor on special initiatives as needed
Set deadlines, prioritize tasks for self, team members, and support groups; review and approve colleagues' work for accuracy and procedural compliance
Collaborate with internal departments and teams to address and resolve quality issues related to facilities and manufactured products
Embrace constructive feedback and critiques as opportunities for personal growth and departmental improvement
Qualification
Required
B.S. in a scientific field (e.g., Biology, Microbiology, Biochemistry) or 3-4 years of equivalent industry experience
2+ years of experience in microbiological testing
Familiarity with regulatory agencies and documentation (e.g., FDA, EP, JP)
Strong computer skills and experience with laboratory data systems
Preferred
Advanced degree in microbiology or related field
Experience with microbiological testing of pharmaceutical products
Background in an aseptic drug products laboratory
Knowledge of Kaizen, Six Sigma, and/or Lean principles
Experience in an isolator-based aseptic drug product manufacturing environment
Project management experience
Company
INCOG BioPharma Services
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$86.63M2024-05-29Series B· $42.86M
2022-05-10Undisclosed· $15M
2022-05-10Debt Financing
Leadership Team
Tedd Green
Co-founder & Chief Operating Officer
Recent News
Inside INdiana Business
2025-12-16
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