QC Microbiology Manager

Employer
Lead Candidate
Location
Fishers, Indiana
Salary
Up to around $110,000 plus benefits
Start date
22 Nov 2021
Closing date
22 Dec 2021

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
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Job Details

QC Microbiology Manager

Who?

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, headquartered in the US, are now looking to appoint a QC Microbiology manager.

Their 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 they build a world-class CDMO for parenteral injectable drugs, 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. 

What?

This is where you come in -  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. 

The QC Microbiology Manager will play a key role in developing 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). Working closely with the Director of Quality Control, the role will include the following responsibilities:

  • Recruit, build, and lead a team to establish a new GMP QC Microbiology Laboratory
  • Train, support, and maintain an engaged workforce competent in microbiological testing required to support a state-of-the-art aseptic drug product manufacturing facility.
  • Lead through coaching, mentoring, and maintaining at-the-bench presence in the laboratory to ensure rigorous scientific and quality work standards.
  • Lead development of a world-class QC platform by leveraging expertise to establish a robust environmental monitoring program and develop laboratory processes that adhere to procedures and regulatory requirements for the evaluation of microbiological aspects of drug products, excipients, and process materials. This minimally includes tests for sterility, endotoxin, and bioburden.

About you...

 As an experienced pharma professional and subject matter expert on all things Microbiology, you would be expected to possess: 

  • B.S. in Biochemistry, Biology, or Microbiology
  • Minimum of 5+ years of biopharma industry experience, of which at least 2 years have been in a role tied to microbiology testing for aseptic drug products
  • Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control.  First-hand experience participating in and/or hosting audits/inspections related to Quality Control
  • Demonstrated experience with microbiology suitability development work and USP/EP microbiology requirements.

In summary...

This is a genuinely rare 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. At an organization that truly values excellence, innovation, accountability, partnership, transparency, and results. They strive to be different, putting our team at the forefront of everything we do and every decision they make. 

If you want to be part of something truly special from an early stage, please contact one of our Talent Champions today!

 



 

Company

Lead Candidate was co-founded by the coming together of three minds.  Two entrepreneurs that have spent their entire careers growing companies in the pharm and bio supply chain.  And a lifelong recruitment expert who knows what it takes to deliver something truly special to professionals in our sector.

Whether you are looking to hire or looking to be hired, Lead Candidate exists for you and only you.  We support companies and professionals in the pharmaceutical and biotech outsourcing space the world over.  We create and curate talent communities with the sole intention of making sure our industry has access to the very best talent.  In doing so we help people achieve their career ambitions and make sure companies achieve their ambitions.

Find Us
Website:
Location
Sunco House
5 Carliol Square
Newcastle upon Tyne
NE1 6UF
United Kingdom

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