Sr. Scientist, Analytical Development

Recruiter
Adicet Bio, Inc.
Location
Menlo Park, California
Posted
Oct 31, 2019
Closes
Nov 10, 2019
Ref
cce085230974
Organization Type
Corporate
SENIOR SCIENTIST - ANALYTICAL DEVELOPMENT

Adicet Bio is seeking an experienced professional to work in the Analytical Development (AD) Department. In this position, the individual will lead and/or execute activities both internally and with the company's external contract manufacturing and contract testing partners for the development, validation and implementation of biological methods and controls to support product development and commercialization. The individual will ensure compliance with applicable regulatory and industry standards for phase appropriate development of the company's products.

KEY RESPONSIBILITIES
  • Develop, optimize and qualify/validate cell-based and binding based functional potency assays, and other in vitro and in vivo biological test methods for the characterization, release testing and stability monitoring of drug products.
  • Develop cell lines, reagents, reference standards and controls to enable biological methods for the characterization, release testing and stability monitoring of drug products.
  • Collaborate with the internal and external partners to lead, design and execute Analytical studies to enable clinical, process development, and stability programs.
  • Lead and manage analytical method technical transfer to Quality Control (QC), Contract Testing Laboratories (CTL) and Contract Manufacturing Organizations (CDMO).
  • Create, compile and review technical and regulatory documents including but not limited to analytical study data summaries and reports, analytical method development reports, method qualification/validation protocols and reports, standard operating procedures in compliance with regulatory requirements.
  • Lead, perform characterization, and product attribute criticality assessments from candidate nomination through IND- and BLA -enabling activities and ultimately commercial registration.
  • Lead, manage and provide mentorship and scientific guidance to technical staff.

QUALIFICATIONS:
  • D. degree in Immunology, Molecular Biology, Microbiology, Cell Biology, Pharmacology or related field is required, T cell expertise preferred.
  • Minimum of five years of experience in the academia, biotechnology or pharma industry with a primary focus on the development and qualification of functional potency and other biological assays is required.
  • Experience in CAR-T, gene therapy and/or cell therapy is a plus.
  • Familiar with technologies like: flow cytometry, cell counting, PCR, Blots, immunoassays and other cutting-edge biological analysis methods in regulated environments is a plus.
  • Familiar with Drug Development Process, ICH and GMP regulations is a plus.
  • Excellent interpersonal and strong leadership skills with the ability to influence and liaise in a cross-functional team environment.
  • Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates and externally with third party contract organizations.
  • Excellent written and oral communication skills with a proven track record of developing employees.
  • Self-motivated and detail-oriented, with the highest integrity.
  • Ability to work independently, multitask and meet deadlines in a fast-paced environment.

BENEFITS:

Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.

Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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