Lead Candidate has the privilege of partnering with organisations who are growing something special, making a difference to society through improved patient therapies and care. One such partner, INCOG Biopharma Services, headquartered in the US, is on the verge of ambitious growth and is looking to expand their team.
INCOG’s culture and priorities are different by design: focused on building long-term value for customers, committed to a service-culture mindset, technical excellence, and a collaborative and team-centred approach to doing business.
As INCOG builds a world-class CDMO for parenteral injectable drugs, they have recently completed construction of their GMP facility, but the journey has only just begun, which provides the opportunity to leverage knowledge gained over multiple careers to “do it right” in all respects.
In support of their growth ambitions, INCOG BioPharma Services have multiple positions for a QC Microbiologist available. There is a day shift, and a 2nd shift to support increased production efforts and work Monday to Friday, 3pm to 11pm.
So, 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.
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.
- 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.
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.
You 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.
You will also:
Thrive in a team environment but can work autonomously with strong self-management and organizational skills.
Commit to a culture of quality with skills including attention to detail, on time delivery, and efficiency.
This is an opportunity to be involved in building a new world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, clients, and patients. With an organization that values excellence, innovation, accountability, partnership, transparency, and results. They strive to deliver their work by putting the team at the forefront of everything they do and every decision they make.
Lead Candidate are delighted to be partnering with the team at INCOG BioPharma Services and would love to tell you more about the future of this innovative organisation. If you want to learn more, the please get in touch at email@example.com