Manager Analytical Development

Company: National Staffing Consultants (Discover Top Talent
Location: Trenton
Posted on: June 23, 2022

Job Description:

Manager Analytical Sciences- Princeton, NJ Area -NEW! Exciting opportunity to join a world class organization! The Manager Analytical Sciences, Princeton will manage the Cell Therapy Analytical Development (AD) team and will oversee highly specialized technical research to support the development, optimization, qualification and execution of cell-based, nucleic acid-based, protein-based and chemistry-based assays that support quality control of cell therapy products under development and manufacturing. This position entails experience and understanding of analytical design and development to establish new analytical methods and standard procedures for cell therapy product characterization.Overview:

• Oversee day-to-day AD activities and provide technical guidance to the team to develop, qualify and tech transfer assays to assess identity, purity, safety and potency of cell therapies including but not limited to FLOW cytometry, PCR/ddPCR, ELISAs, and cytotoxicity assays
• Support the technology transfer of analytical methods to QC and assist QC with analytical method qualification and validation
• Work closely with the Director of Process Sciences and participate in building a strong AD team, including defining its vision, strategy, execution, hiring, training, staff assignment, coaching, mentoring and performance management
• Manage all project scopes, resource requirements, project timelines and deliverables and plan/coordinate project work accordingly with departmental, functional and external stakeholders.
• Collaborate with Program Management to ensure clear expectations and successful deliverables.
• Serve as primary contact with clients and provide regular communication of data and status and lead relevant program team meetings.
• Work with Process Development and Manufacturing groups to trouble-shoot process challenges.
• Oversee recording of results and preparation of protocols, reports, test methods, and SOPs.
• Direct a team of people leaders and scientists to driving customer engagement and Cell Therapy Analytical Services revenue through early adoption of disruptive technologiesAct as lead on multiple programs and provide guidance to other program managers. Investigate, design, and validate new scientific methodologies on highly critical, unique, and complex projects related to cell therapy analytical science.
• Plan and manage significant technical/scientific project activities to execute strategies and provide solutions that meet client needs and expectations through broad expertise.Requirements:
  • Bachelor's Master's or PhD in biology, chemistry, biochemistry, biomedical engineering, or a related field.
  • 6 years' experience related to pharmaceutical manufacturing, process, or analytical development
  • 3-5 years' experience leading teams of Scientists
  • Candidate must have good understanding of analytical method development and characterization as it pertains to cell therapy.
  • Advanced and deep knowledge of principles, concepts, and practices in cell therapy
  • Experience working with various cell types (including T cells, NK cells, CAR-T, or Stem Cells) as well as viral or non-viral genetic modification is preferred.
  • Experience working in a CDMO is preferred.
  • Strong knowledge of GMP regulations as it pertains to best practices in cGMP manufacturing.
  • Demonstrated leadership, problem solving and critical thinking skills.
  • Excellent writing, communication, and presentation skills.

Keywords: National Staffing Consultants (Discover Top Talent, Trenton , Manager Analytical Development, Executive , Trenton, New Jersey