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Director, Quality Control - GMP - Life Sciences

Employer
TriLink BioTechnologies, part of Maravai LifeSciences
Location
San Diego County, CA
Closing date
May 18, 2022

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TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a Director of Quality Control to join our growing team. TheDirector of Quality Control is responsible for leading groups of scientists in Quality Control functions. The candidate is responsible to streamline QC workflows while maintaining QC output and metrics. This includes creating dedicated core manufacturing and GMP manufacturing QC groups. The head of QC is also responsible for providing expert technical support both internally and externally, overseeing CRO contract testing/technical transfer and working with QA to assure cGMP compliance. In addition, the candidate is responsible to align QC with analytical development activities required to develop methods to characterize and analyze all products made by TriLink. This includes capping analogs, mRNA and oligonucleotides.
Responsibilities
  • Support all QC functions related to non-GxP (core) and GxP (pre-clinical & cGMP) activities
  • Provide expert technical support for clients and on-site GMP manufacturing facility, QC systems, technical transfer, troubleshooting, method development and phase-appropriate validation
  • Responsible for customer facing during discussions of analytical work packages with an emphasis on helping clients understand developmental requirements
  • Manage group resources, evaluate instrumentation and staffing levels, with an emphasis on improvements in interdepartmental workflows, client-focused services and associated KPI
  • Create, edit, review and approve SOPs
  • Review and approve deviations, OOS and OOT investigations
  • Manage stability study projects both internally and externally
  • Coordinate specialized contract testing for product and raw material characterization as well as review and approval of COA's received from contract laboratories
  • Perform audits of CROs when necessary
  • Assist in development of novel analytical methods for analysis of mRNA, oligonucleotides, NTPs and capping reagents
  • Perform trend analysis of testing data to establish product release specifications for in-process and finished product
  • Establish and drive scientific strategies to leverage knowledge and capabilities of quality control group, assist analytical development group, and effectively plan resource allocation to achieve team goals
  • Continually interact with and help TriLink's production and analytical teams in troubleshooting synthesis, purification and analytical problems
  • Provide timely and well-organized reports to project teams
Qualifications
  • Master of Science (MSc) or Doctoral degree (PhD) or equivalent in synthetic organic chemistry or analytical chemistry in the field of nucleic acids, oligonucleotides, nucleotides and nucleosides
  • 10+ years of experience in the biotech industry, with a strong track record of scientific innovation and success in delivering of novel products
  • In-depth knowledge of the entire R&D processes and QC functions, expertise in physical methods of investigation and in analytical methods and characterization of Nucleic acids and their components
  • A strong track record in Quality Control and analytical chemistry of Nucleic acids
  • A solid background in biochemistry and biology of nucleic acids and their components is a plus
  • A leader with effective organizational, interpersonal, communication and managerial skills who can motivate and inspire others
  • Demonstrated leadership of project teams in a cross-functional environment
  • Demonstrated technical proficiency, scientific creativity, independent thought, and ability to effectively collaborate with others
TriLink BioTechnologies is a rapidly growing biotech firm in San Diego, CA, that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.
TriLink BioTechnologies is an EEO employer.
Receipt of a copy of your COVID-19 Vaccination Record Card reflecting fully vaccinated status prior to date of hire is required
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