This is an exciting opportunity responsible for serving as a SME for biosafety and microbiology testing within a major US BioPharma manufacturing facility producing clinical stage monoclonal antibodies, cell & gene therapies and ADCs. You will be charged with overseeing the following activities:
* Leading and providing scientific and compliance-minded expertise in the areas of viral and biosafety testing for QC, with support focus to include emerging technologies and technology development.
* Serving as a Subject Matter Expert (SME) in viral and biosafety testing, mycoplasma and sterility testing, as well as routine microbial testing including endotoxin, sterility, and bioburden testing.
* Providing technical and scientific expertise performing viral titer assays (TCID50, FFU), mycoplasma testing by tissue/cell culture, qPCR and endotoxin testing.
* Serving as a liaison between Biopharmaceutical Development, Quality Assurance and external testing laboratories.
* Leading QC Microbiology related Manufacturing Science and technical troubleshooting activities including deviation handling, investigations, risk mitigation and microbial identification.
* Authoring and approving quality systems records including investigations, CAPAs and SOPs as well as technical documents including trend reports, qualification and validation documents)
* Serving as SME and Data Integrity champion for laboratory activities.
* Serving as a Lean champion, embracing Lean tools and principles and implementing continuous improvement initiatives.
* Training and mentoring team members on biosafety and microbiology processes and lab equipment.
* Ensuring Microbiology and biosafety related compliance and interactions with regulatory agencies including FDA & EMEA during audits and inspections.
Desired Skills & Experience
* Masters degree or Ph.D. in Microbiology, Virology, Molecular Biology or related life sciences field.
* 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
* Hands-on expertise leading viral and biosafety testing, mycoplasma and sterility testing as well as routine microbial testing including endotoxin, sterility, and bioburden testing.
* Technical and scientific expertise performing viral titer assays (TCID50, FFU), mycoplasma testing by tissue/cell culture, qPCR and endotoxin testing.
* Expertise in virology, viral transfection, viral vectors or resolving viral contamination.
* Expertise leading microbiology and biosafety related investigations with successful experience resolving related deviations.
The position is within a top BioPharma company that is rapidly growing its development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity work in a major award winning Maryland based state-of-the-art large scale commercial biologics manufacturing facility. This site is a worldwide industry leader in mammalian cell culture manufacturing and has a promising pipeline of incoming monoclonal antibody/ recombinant protein therapeutic products.
This is an on-site full-time position and offers a competitive base salary, target bonus, LTI's (stock) and comprehensive benefits package. A full relocation package is also offered for this position.