Senior QC Microbiologist

The Quality Control Senior Microbiologist will work closely with the full Quality Control team, Quality Assurance and Manufacturing to develop and execute the microbiological testing of a wide variety of materials critical to and inclusive of the parenteral drug product manufacturing process. Such testing includes, but is not limited to: Bioburden, Endotoxin, Sterility, Hold-Time Studies, Hypothesis Testing, and Environmental/Utilities Monitoring.

The Senior Microbiologist will be committed to operating with a Quality Mindset in every aspect of their role, including attention to detail, on time delivery, and efficiency. They will generate, participate in, SME for, and review process critical Quality Events (Laboratory Investigations, CAPAs, Deviations, Continuous Improvements etc.).

The Quality Control Senior Microbiologist will demonstrate an ability to define problems, propose solutions, collect data, establish facts, and draw valid conclusions. It is critical to have excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Senior Microbiologist will exemplify excellent interpersonal skills and be capable of developing productive cross-functional relationships within the company. They will thrive in a dynamic, fast paced team environment but can also work autonomously with strong self-management and organizational skills. Additionally, the Microbiologist will possess a demonstrated ability to influence positive outcome within the QC Microbiology team and take ownership of processes/systems.

Essential Job Functions:

• Participate as a key player in establishing and improving the QC Microbiology Laboratory team.

• Perform and improve testing including, at a minimum, sterility, endotoxin, and bioburden. Testing will be performed on Drug Products (API, BDP, FIP, and AI), excipients, and in-process materials.

• Develop, improve, and participate in a robust Environmental and Utilities Monitoring program.

• Hold self and others accountable for rigorous scientific and quality work standards.

• Perform microbiological testing required to support a state-of-the-art aseptic drug product manufacturing facility.

• Utilize various paper and automated systems to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.

• Generate, review, own, and complete Quality Events efficiently and to a high degree of accuracy. Interpersonal Focus

• Train fellow QC personnel on instruments, processes, and assays when cross-training or new employee training is needed.  Assist in the professional support and development of QC Microbiology Technicians within the QC lab.

• Be team oriented and willing to act as both a facilitator of special projects and a contributor to special projects when needed.

• Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by co-workers for accuracy and alignment with procedures.

• Collaborate with internal departments and teams to resolve quality issues regarding facility, products manufactured and released.

• View constructive criticism and critiques to work and documentation as opportunities to improve themselves and the quality of the department; can also give feedback in a constructive manner.

Special Job Requirements:

• B.S. in Science (Biology, Microbiology, Biochemistry etc)

• 3+ experience with microbiological testing.

• High proficiency level in performing bioburden, endotoxin and sterility testing. Ability to evaluate, troubleshoot, and investigate testing results as they apply to the pharmaceutical process.

• Possesses an excellent working knowledge of regulatory guidance (FDA, EP, JP etc).

• Exceptional computer skills and data management both digital and manual.

Additional Preferences:

• Advanced microbiology specific degree.

• 4+ years of experience in GMP biopharma industry in an aseptic drug product QC laboratory role.

• Experience with Kaizen, Six Sigma, and/or Lean principles.

• Experience in an isolator-based aseptic drug product manufacturing facility.

• Project Management experience

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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