Microbiologist (2nd Shift)
Description
We are seeking a Quality Control Microbiologist who has a passion for learning, collaborating, and contributing to the success of our clients. The Microbiologist will be dedicated to the success of the Quality Control team, resulting in the production of the highest quality products for our clients.
The Quality Control Microbiologist will work closely with Quality Control leadership and will develop the program for performing microbiological in-process, release, and stability testing of parenteral injectable products and the requisite supporting testing (e.g. environmental monitoring, cleaning validation, incoming QC). The 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.
The Quality Control Microbiologist will demonstrate an ability to define problems, 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 Microbiologist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with subordinates and colleagues, customers, suppliers, and partners. 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 without direct reporting authority.
This is a 2nd Shift Position.
Essential Job Functions:
- Participate as a key player in establishing the GMP QC Microbiology Laboratory.
- Partner with leadership in the development of a world-class QC platform which will include a robust environmental monitoring program, and laboratory processes that adhere to procedures and regulatory requirements for the evaluation of microbiological aspects of drug products, excipients, and process materials. This includes, at a minimum, tests for sterility, endotoxin, and bioburden.
- Leadership role in partnering with program owners to develop PM and calibration plans to coordinate upkeep, conformity and IQ/PQ/OQ of instruments and laboratory environment.
- Collaborate with the Quality Team on building laboratory safety program to ensure a safe and quality-minded environment for all personnel working in the laboratory.
- Perform microbiological testing required to support a state-of-the-art aseptic drug product manufacturing facility.
- Holds self and others accountable for rigorous scientific and quality work standards.
- Advocate for clients by collaborating cross-functionally to schedule microbiological sampling, testing, instruments, and personnel to meet customer needs and timelines.
- Maintain a constant state of safety and inspection-readiness in the QC laboratories. Use knowledge of quality principles, cGLPs, cGMPs, and regulatory standards to act as a key point-of-contact for regulatory agencies during inspections and audits.
- Support laboratory investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events.
- 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.
- Use applied statistics to analyze and track test results to identify sources of variability and error in laboratory and manufacturing processes. Use data trends to apply a systematic approach to resolve technical issues, prevent errors, identify improvement opportunities, and implement continuous improvement plans.
- Maintain regulatory intelligence on the regulatory landscape, policies, and pharmaceutical industry trends through continuous education, networking, literature, trade organizations, etc.
- Develop and perform: Endotoxin, Bioburden, and Sterility (Rapid and Traditional) testing using cutting edge technology on development, clinical, and commercial products.
Special Job Requirements:
- 2+ years of microbiology, biology, or other related experience.
- Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control.
- Experience with using laboratory instrumentation that analyze for sterility, endotoxin, and bioburden.
- Exceptional computer skills evidenced by hands-on work with automated data management. and/or data analysis systems (LIMS, JMP, minitab, etc.).
- B.S. in Biochemistry, Biology, or Microbiology.
Additional Preferences:
- Advanced Degree.
- Minimum of 2+ years of biopharma industry.
- Experience years have been in an aseptic drug products laboratory role.
- Design or use experience with LIMS (Laboratory Information Management Systems).
- 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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