Associate Director/Director, LSAT- Stability & Compliance

CRISPR Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Post Date: 02/15/2021
  • 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

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.

Job Summary

We are seeking an Associate Director/Director to join in Late-Stage Analytical Development (LSAT) department, in an exciting, fast-growing, and well-financed company to develop novel gene editing therapies for serious diseases at CRISPR Therapeutics. The successful candidate will be responsible for establishing a stability and compliance programs for PPQ and BLA. The position will interface with Technical Operations, Research, CDMOs/CMOs and R&D to provide a strategic view of late Stage development to meet the needs of our growing clinical products portfolio and launch of commercial product. The ideal candidate has significant experience with analytical development, validation, tech transfer, stability program management and data review and compliance.

Responsibilities

  • Expand and establish robust stability and compliance program for clinical programs and starting materials.
  • Provide monthly updates on Stability and Compliance activities to senior management and stake holders.
  • Expand Late-stage analytical assay qualification, validation tech transfer group.
  • Qualify and validate phase appropriate analytical “fit to use” in QC Labs.
  • Maintain a strategic view of the relationship with internal and external partners in Manufacturing to form a strong and effective partnership.
  • Maintain information flow from LSAT group to enable monitoring of the relationships with CDMOs and other vendors.
  • Manage the Stability Program for Crispr clinical programs and critical starting materials.
  • Manage Reference Standard Group
  • Write Justification of specifications and work with QA to implement the specifications.
  • Work with life cycle management group to improve the current assays for automation and high throughput of GMP analytical assays.
  • Manage the Data review and Data Management group and build a culture of data integrity
  • Perform documentation review to ensure proper controls and data integrity
  • Manage Lab Investigations, OOS, Change control and deviations

Minimum Qualifications

  • Ph.D. with +10 yrs. Experience; or MS with +12 yrs. experience; experience in the development and validation of analytical assays and systems in the manufacturing of biopharmaceuticals for cell and gene therapy products, monoclonals, proteins, and Vaccines
  • Experience in managing Stability program and Reference Standard Groups.
  • Experience in working with CDMOs and third parties for analytical development, qualification and validation and other cGMP manufacturing activities.
  • Experience in risk management process (CQA, FMEA), Lab investigations, OOS and Deviations.
  • Highly skilled in statistical methods, statistical process control, sampling plans, and design of experiments
  • Ability to effectively communicate and collaborate with internal and external stakeholders is essential.
  • Proven ability to mentor and coach more junior team members and develop a strong team.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion.
  • Self-driven, independently motivated, data driven and excellent problem-solving ability.
  • Available to travel both domestically and internationally.

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.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

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