Senior Scientist, Analytical Development

CRISPR Therapeutics•South Boston, MA

2d•Onsite

About The Position

Company Overview Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY ® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals . CRISPR Therapeutics AG is headquartered in Zug, Switzerland , with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Job Summary Reporting to the Director of Analytical Development, the Senior Scientist will be responsible for development, implementation, and qualification of cell-based assays (potency, immunogenicity, etc.). The candidate will lead cell-based analytical technology transfers from Analytical Development to collaborators within and outside CRISPR Therapeutics. They will also author sections of regulatory briefing packages or submissions related to technical role .

Requirements

Ph.D. in Biology, Chemistry, Chemical Engineering or related discipline with 4 - 8 + years of post-PhD relevant industry experience , or non-PhD with 12-15 years of relevant experience.
Proficient in mammalian cell culture, flow cytometry, droplet digital PCR, sanger sequencing, and amplicon next generation sequencing platforms.
Proficient in statistical analyses software, including JMP, GraphPAD , Qubas , Softmax , FlowJo , MACSQuantify .
Proficient in parallel line analysis for interpretation of potency data.
Expertise applied to both ex-vivo and in-vivo cell and gene therapy platforms.
Experience in leading assay lifecycle management for Cell and Gene Therapy products is strongly desired.

Nice To Haves

Ability to mentor a team of scientists into increasing responsibility.
Experience with authoring regulatory submission documents.
Experience with leading analytical method transfer and supporting process technology transfer.
Awareness of regulatory guidelines in FDA and EMA guidance documents, CFR, ICH, USP, and Ph. Eur.
Proficient in risk assessments to support comparability assessments, process and method changes, and establish drug product critical quality attributes.
Ability to work in cross functional teams supporting product development and tech transfers.

Responsibilities

Lead a team responsible for the development, optimization, and technology transfer and qualification of cell-based assays for Drug Products and Drug Substances across the CRISPR portfolio, including potency assays for ex-vivo and in-vivo programs.
Lead the team in qualifying and maintaining cell lines for various potency assays.
Expertise in flow cytometry-based assays required to support various cell-based testing.
Lead team responsible for trending potency data and establishing specifications for lot release and stability studies .
Provide technical and operational oversight to contract labs supporting cell-based potency tests for multiple products across the portfolio.
Maintain awareness of applicable regulatory guidelines in area of expertise, including but not limited to guidelines from ICH, USP, EP, and JP.