Senior Manager Analytical Development

Location
92121, San Diego
Posted
Sep 28, 2021
Hotbed
NextGen Bio
Required Education
Doctorate/PHD/MD
Position Type
Full time

Position Summary:

The role of the Senior Manager, Analytical Development is to help establish and lead the Analytical Development (AD) function. The AD function is responsible for qualifying, validating, and transferring analytical methods per USP and ICH guidelines, in addition to technical support activities such as QC investigations and special studies.

The incumbent will set up an analytical lab, hire personnel, and establish SOPs.  The ideal candidate will have strong technical, leadership, and communication skills.

Key Responsibilities:

  • Develop and manage Artiva’s Analytical Development program.
  • Establish AD timelines, budgets, and SOPs.
  • Lead the effort to setup analytical testing laboratories, including equipment selection and installation.
  • Hire and train Analytical Development staff; participate in hiring of QC staff as required.
  • Oversee phase-appropriate qualification and validation of QC analytical test methods per USP and ICH guidelines.
  • Write or approve analytical method development reports, analytical qualification and validation protocols and reports.
  • Oversee the continuous improvement of QC methods as needed. Perform supplemental qualification or validation as appropriate.
  • Oversee analytical method transfers for QC release assays as required.
  • Propose acceptance criteria and control limits, with appropriate justification.
  • Provide technical support, training, and guidance on analytical testing issues and investigations as required.
  • Provide support for special studies, proof of concept studies, process qualifications, etc.
  • Develop and apply a working knowledge of safety and efficacy testing related to NK and CAR-NK products.
  • Understand the operation of ELISA, Flow Cytometers, automated cell counters, qPCR thermocyclers and other analytical instruments and equipment, as needed.
  • Perform routine testing as required.
  • Maintain records and databases in accordance with procedures.
  • Develop and manage department performance metrics.
  • Supervise Analytical Development personnel as required.

Education and Experience:

  • PhD/Masters in a scientific field relevant to cell therapy
  • 10+ years of US regulatory compliance experience in biologics or pharma
  • 3+ years of cell therapy experience
  • 3+ years of supervisory experience
  • Advanced/Expert understanding of analytical statistics
  • Basic understanding of current Good Manufacturing Practices as they relate to the testing of cell therapy products for human clinical trials
  • Expert knowledge of method transfers, qualifications, and validations; current industry practices; and strong experience with guidance interpretation and application
  • Computer skills required to operate Microsoft Word, Project, Visio, and Excel programs
  • Excellent verbal and writing skills

Artiva is an Equal Opportunity Employer