Senior Specialist/Manager, QC Environmental Monitoring

CRISPR Therapeutics

Framingham, MA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 04/02/2021
  • 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

The Quality Control team is looking for dynamic Environmental Monitoring (EM) Subject Matter Expert with experience managing and monitoring the EM Program in pharmaceutical/aseptic operations. This position will support the development and implementation of the EM Program at the site and its corresponding procedures, methods, and laboratory best practices to ensure a robust and sustainable process and providing direct support to the manufacturing and analytical operations. The EM Sr. Specialist/Manager will be based in Framingham, MA, and reports to the QC Microbiology Sr. Manager.

Responsibilities

During the facility completion stage, this position is responsible for:

  • Facilitating installation and qualification of equipment in the environmental monitoring laboratories. This includes protocol execution and data analysis.
  • Facilitating the implementation of the EM Program at the Framingham facility, which will include the sampling and monitoring of corresponding gas utilities used for operational activities.
  • Authoring, reviewing, and approving policies, SOPs, Test Methods, and related documents needed to establish and operate the EM Program in compliance with cGMP regulations.
  • Supporting the implementation of the electronic EM and data management system.
  • Facilitating the development and implementation of the EM sampling plans and their integration into LIMS and/or other system(s).

Upon completion of facility commissioning and qualification, this position is responsible for:

  • Facilitate the collection and processing of environmental samples (including gas utilities) for the release of the facility to start qualification runs.
  • Monitoring the manufacturing suites and controlled areas before and during operations based on the established sampling plans.
  • Performing applicable testing (i.e., microbiological, chemical, etc.) of EM samples and document analytical results.
  • Reviewing and dispositioning in-house and 3rd party EM analytical data, as applicable.
  • Preparing EM data trend charts and analyze and report findings based on approved procedures.
  • Ensuring equipment and instruments required for sample collection and analysis are maintained in a calibrated state and are set up/programmed appropriately.
  • Maintaining appropriate levels of testing media and related supplies.
  • Reviewing and dispositioning equipment and instruments reports, such alarm logs and temperature charts.
  • Supporting facility, utility, and equipment projects with potential EM impact, as needed. This includes supporting Change Control activities, creating and/or executing sampling plans or protocols, performing sample collection and analysis, participating as SME in risk assessment exercises, among others.
  • Managing change controls, EM excursions, OOS/OOT events and driving EM deviations to closure in a timely manner.
  • Serving as the SME for EM during regulatory audits and filings.
  • Maintaining the EM Program and system in a compliant manner.
  • Representing EM on cross functional teams supporting manufacturing/analytical initiatives.
  • Performing other duties based on business needs.

Qualifications

Bachelor’s degree in Microbiology, Biology or related discipline.

  • Minimum 8 years of relevant work experience, preferably in pharmaceutical/aseptic manufacturing.
  • Experience with data review in a QC environment.
  • Experience managing EM programs and safety release testing of drug products such as rapid microbial detection and Endotoxin systems.
  • Knowledge of aseptic technique, gowning procedures, and risk assessments.
  • Strong understanding of applicable regulations related to EM.
  • Effectively collaborate with both internal and external stakeholders.
  • Ability to work independently and effectively, prioritize and deliver on tight timelines.
  • Outstanding problem-solving abilities.
  • Demonstrated ability to work in a collaborative environment with a quality and positive mindset and hands-on approach that emphasize teamwork and consensus.
  • Experience with Cell Therapies, AAV and LIMS is preferable.

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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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.