Manager Analytical Development
Company: National Staffing Consultants (Discover Top Talent
Posted on: June 23, 2022
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
- 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
- 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
- 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
- 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
- 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
- Excellent writing, communication, and presentation skills.
Keywords: National Staffing Consultants (Discover Top Talent, Trenton , Manager Analytical Development, Executive , Trenton, New Jersey
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