Senior Manager, Quality Control Microbiology
Company: CRISPR Therapeutics AG
Posted on: June 6, 2021
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.
The Quality Control team is looking for dynamic microbiologist
leader with experience managing QC microbiology and environmental
monitoring laboratories. This highly visible position will
establish good practices and continuous improvement programs for
microbiology-related activities, including managing and developing
the QC Microbiology team. The QC Microbiology Sr. Manager will be
based in Framingham, MA, and reports to the QC Director.
During the facility completion stage, this position is
- Overseeing equipment installation and qualification in the
environmental monitoring and QC microbiology laboratories.
- Implementing the Environmental Monitoring program at the
- Authoring, reviewing, and approving policies, SOPs, Test
Methods, and related documents needed to operate a QC laboratory in
compliance with cGMP regulations.
- Recruiting and on-boarding QC analysts.
- Supporting the implementation of an electronic data management
Upon completion of facility commissioning and qualification,
this position is responsible for:
- Oversight of microbiological testing programs for all stages of
clinical and commercial manufacturing operations including
endotoxin, bioburden, sterility testing, microbial ID testing, raw
materials, water, and environmental monitoring.
- Developing, implementing, and maintaining of quality control
- Managing change controls, EM excursions, OOS/OOT events and
driving deviations to closure in a timely manner.
- Serving as the SME for QC Microbiology during regulatory audits
- Maintaining the QC Microbiology laboratory in a compliant
- Representing QC-Microbiology on cross functional teams
supporting raw material initiatives.
- Creating and managing material specifications associated to
- Managing raw material samples testing schedules with internal
and external testing labs.
- Developing cooperative and strong working relationships with
Manufacturing, Quality Analytical Science, Quality Assurance, and
other stakeholders to achieve company objectives.
- Supporting regulatory submissions (e.g. INDs, BLAs).
- Participating in business sub-teams as a subject matter expert
to provide input on timeliness and to address environmental
monitoring and microbiology related issues.
- Coaching and development of QC Microbiology personnel.
- Align departmental objectives with overall Company/Quality/QC
goals and priorities.
- Assure a safe work environment (in lab and office spaces) for
QC Microbiology personnel.
- Performing other duties based on business needs.
- Bachelor's degree in microbiology, biology, or related
- Minimum 7 years of relevant work experience, preferably in
aseptic manufacturing of cell therapies or AAV products.
- Experience managing environmental monitoring programs and
safety release testing of drug products.
- Strong understanding of applicable USP, ICH, and Ph Eur
regulations related to QC testing.
- Experience with generating material specifications for
- Effectively collaborate with both internal and external
- Ability to work independently and effectively, prioritize and
deliver on tight timelines.
- Outstanding problem-solving abilities.
- Demonstrated ability to lead in a collaborative environment
with a positive leadership style and hands-on approach that
emphasize teamwork and consensus.
- Experience with cell therapies, AAV and LIMS is
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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Keywords: CRISPR Therapeutics AG, Framingham , Senior Manager, Quality Control Microbiology, Other , Framingham, Massachusetts
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