Senior Scientist, Analytical Development

Crispr Therapeutics Inc in; Boston (MA); On-site; USD 140,000 - 155,000; Full time

Job summary

CRISPR Therapeutics, Inc. in Boston, MA, seeks a Senior Scientist in Analytical Development to drive development, implementation, and qualification of cell-based assays and to lead transfers to collaborators.

This role will author sections of regulatory briefing packages related to the technical function. The candidate will manage cross-functional teams, ensure alignment with ICH/USP/GMP guidelines, and participate in lifecycle management for Cell and Gene Therapy products.

Qualifications

• Ph.D. in Biology, Chemistry, Chemical Engineering or related discipline with 4-8+ years post-PhD industry experience, or non-PhD with 12-15 years of experience.
• Proficient in mammalian cell culture, flow cytometry, ddPCR, Sanger sequencing, and amplicon next generation sequencing platforms.
• Proficient in statistical analyses software, including JMP, GraphPAD, Qubas, Softmax, FlowJo, MACSQuantify.

Responsibilities

• Lead a team responsible for development, optimization, technology transfer and qualification of cell-based assays for Drug Products and Drug Substances across the CRISPR portfolio.
• Lead the team in qualifying and maintaining cell lines for potency assays.
• Expertise in flow cytometry-based assays to support cell-based testing and establish specifications for lot release and stability studies.
• Provide technical and operational oversight to contract labs supporting cell-based potency tests for multiple products.

Skills

Mammalian cell culture

Flow cytometry

ddPCR

Sanger sequencing

Amplicon sequencing

Parallel line analysis

Education

Ph.D. in Biology, Chemistry, Chemical Engineering or related discipline

Tools

JMP

GraphPad

Qubas

SoftMax

FlowJo

MACSQuantify

Job description

Senior Scientist, Analytical Development (Project Management)

Job Description

Company Overview

Founded over a decade ago,CRISPR Therapeuticsis 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 Therapeuticsis 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 Therapeuticshas established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals .CRISPR Therapeutics AGis headquartered inZug, Switzerland , with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan Francisco, California.

Job Summary

Reporting to the Director of Analytical Development, the Senior Scientist will be responsiblefordevelopment, 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 .

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.

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.

Compensation

Senior Scientist, Analytical Development: Base pay range of $140,000 to $155,000+ bonus, equity and benefits

The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

Equal Employment Opportunity

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.