If you’re looking to be part of something special, making a difference to society through improved patient therapies and care, this could be the opportunity for you.
Lead Candidate are delighted to be working with the team at INCOG BioPharma Services as they build a world class CDMO for parenteral injectable drugs in Fishers, Indiana. They are in the process of constructing the GMP facility and organization from the ground-up, which provides the opportunity to leverage knowledge gained over multiple careers to “do it right” in all respects.
This is where you come in – if you’re a Microbiologist who has a passion for learning, collaborating, and contributing to the success of our clients – we want to hear from you! The Microbiologist will be dedicated to the success of the Quality Control team, resulting in the production of the highest quality products for 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. You will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with subordinates and colleagues, customers, suppliers, and partners.
Some aspects of the role will include:
- 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.
- Perform microbiological testing required to support a state-of-the-art aseptic drug product manufacturing facility.
- 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.
The ideal candidate will have experience of working in a microbiology function within a pharmaceutical environment. Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control is useful, and experience in sterility, endotoxin and bioburden testing is essential.
Interested? Send us your resume at email@example.com
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.