Senior Scientist – Analytical Product Lead (Immuno-Oncology)

CRISPR Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Post Date: 04/22/2021
  • Website: crisprtx.com
  • Company Address: 610 Main Street, Cambridge, MA, 02139

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene-editing company focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.

Job Description

At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.

We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other diseases

Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.

About the position:

  • Design, plan, advise, and monitor strategies for analytical development for all Immuno-oncology products.
  • Lead, facilitate, and contribute to optimization of scientific/technical activities and processes within cell therapies development projects. Provide expertise for enhancing existing assays, and implementation of new ideas and technologies.
  • Represent Analytics in the technical CMC project team.
  • Advise/support in designing method qualification plans per ICH and regulatory guidelines.
  • Participate in investigations, risk analyses and peer reviews; critically evaluate data, and review reports.
  • Collaborate with internal and external partners, CMOs to lead or monitor outsourcing activities and ensure deliverables.
  • Cross-functional and highly visible position within Technical Operations group. Position requires active collaboration with research, process development and quality teams.
  • Author technical reports, protocols, and analytical sections of regulatory filings for US, Europe and ROW.

 

Qualification Required:

  • MS/ Ph.D. in cell biology, immunology, molecular biology, or related sciences with 12+ (MS) or 5+ (Ph.D.) years of relevant industry experience required.
  • Minimum 2 years of relevant hands-on experience in Analytical development and CMC of biologics is strictly required. Prior experience of IND, BLA or equivalent regulatory filings preferred.
  • Strong knowledge of T-cell biology, immunology, analytical methods for cell and gene therapy products is required.
  • Experience with qualifying and validating assays and understanding of ICH/ FDA guidelines is highly desirable.
  • Understanding of statistical tools, such as JMP, DoE, Prism etc. is desirable.
  • Experience of working with and managing external vendors/ CROs is preferred.
  • Strong writing, reviewing, and presentation skills is required.
  • Must have strong organization skills, and ability to multi-task in a fast-paced environment with changing priorities. Must be able to work effectively as part of a multi-disciplinary team.
  • Must be independently motivated, detail oriented with good problem-solving ability.


Competencies

  •  Collaborative – Openness, One Team
  •  Undaunted – Fearless, Can-do attitude
  •  Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
  •  Entrepreneurial Spirit – Proactive. Ownership mindset.

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.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.