Senior Quality Control Stability Specialist

Posted 2 Days Ago
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Boston, MA
Senior level
Biotech
The Role
The Senior Quality Control Stability Specialist collaborates with various teams to ensure a compliant stability program, manages testing schedules, reviews stability protocols, supports regulatory filing, and conducts data analysis using statistical software. They also develop SOPs and assist in investigations of quality issues.
Summary Generated by Built In

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer and 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, and business offices in London, United Kingdom.

Position Summary

Reporting to the Senior Manager, External Quality Control & Stability, the Senior Quality Control Stability Specialist works cross-functionally in a highly visible position across the Technical Operations group. They will actively collaborate with research, process development, quality teams, regulatory and CDMOs to ensure a compliant stability program in addition to providing Quality Control support to ongoing CRISPR Tx programs.

Responsibilities

  • Monitor stability program for upcoming sample testing, manage testing schedules and disposition of material in support of testing, and ensure results are delivered from the testing labs
  • Support data review of cell therapies, AAV products, and Critical Components
  • Maintains completed stability data tables and assesses data trending utilizing applicable statistical software.
  • Review CDMO stability protocols and author/review internal stability protocols
  • Support regulatory filing with stability data tables and trending, as needed
  • Support the transfer and validation of analytical methodology
  • Write and/or revise SOPs and reports
  • Support QC investigations, OOS, deviations, and CAPA implementation
  • Perform other related duties based on business needs including project team representation

Minimum Qualifications

  • Bachelor’s degree in a relevant scientific area, with at least five years in QC/Analytical testing
  • Hands-on experience with flow cytometry, PCR, or ELISA/Multiplex
  • Understanding of ICH Stability guidelines
  • Good knowledge of QA compliance skills
  • Experience in data review, organization, and analysis using statistical software
  • Excellent communication skills, technical writing, and attention to detail
  • Excellent organization skills, able to multi-task in a fast-paced environment with changing priorities. Must be able to work effectively as part of a multi-disciplinary team.

Preferred Qualifications

  • Experience with cell and gene therapies

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 believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect.

The Company
Cambridge, MA
508 Employees
On-site Workplace
Year Founded: 2013

What We Do

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.

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