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Manager, Analytical Development (Specifications, Critical Reagents & Reference Standards) (Contract)

Company: CRISPR Therapeutics
Location: Cambridge
Posted on: May 14, 2022

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

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.

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Keywords: CRISPR Therapeutics, Cambridge , Manager, Analytical Development (Specifications, Critical Reagents & Reference Standards) (Contract), Executive , Cambridge, Massachusetts

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