Manager, Analytical Development (Specifications, Critical Reagents & Reference Standards) (Contract)
Company: CRISPR Therapeutics
Location: Cambridge
Posted on: May 14, 2022
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Job Description:
Company Overview
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.
Responsibilities Lead Specification Rationale Report Drafting
Collect data from reports, Certificates of Analysis and other
sources and analyze using Prism, Excel and JMP software to generate
tolerance intervals and other appropriate graphics
Use manufacturing data, guidance documents, regulatory input and
other information from SMEs to justify specification acceptance
criteria
Collect and record information on test methods, testing sites and
qualification/status
Build powerpoint presentations presenting data for specification
committee meetings
Generate additional documents in support of new specifications and
specification changes.
Work closely with QA to on document finalization and closing of QA
specification change controls
Act as Analytical liaison for establishment of analytical assay
Critical Reagents Program
Compile comprehensive list of analytical reagents needed for
Release Assays for drug product, AAV, Cas9 and sgRNA
In collaboration with QC, develop system for tracking inventory of
custom reagents including resupply, yearly
retesting/requalification and internal/external (CMO/CTO)
distribution for clinical phase programs
In collaboration with QC, develop alternative sources for
non-custom reagents needed for conducting release assays
Support Reference Standard Program
Identify suitable reference standards by coordinating with
appropriate analytical, PD, MSAT, Internal Manufacturing and
External Manufacturing SMEs. Coordinate feasibility studies
Assist with Reference Standard qualification, stability, inventory
and distribution logistics for clinical phase programs including
documentation
Qualifications
BS in Technical field with greater than 6 years of industry
experience in related role or MS Technical field with greater than
2 years in related role
Must have basic project management skills
Highly organized with ability to multi-task in a fast-paced
environment with changing priorities.
Experience working with external vendors
Prior experience in CMC environment is highly desirable
Prior experience in cell and gene therapy is a plus
Strong writing, reviewing, and presentation skills are required
Strong collaborative skills across matrix team members are
required
Experience with spreadsheets, statistical software and other
data/inventory management applications highly desirable.
Experience working with LIMS is preferred
Highly motivated, detail oriented with good problem-solving
ability.
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
Keywords: CRISPR Therapeutics, Cambridge , Manager, Analytical Development (Specifications, Critical Reagents & Reference Standards) (Contract), Executive , Cambridge, Massachusetts
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