Job Highlights
Not Disclosed
Remote Job
Director
Job details
ANALYTICAL CMC CONSULTANT
2-3MTH short-term paternity cover
100% remote
Open to 1099 or W2
LOOKING FOR AN IMMEDIATE START
Reporting into the Associate Director CMC Analytical, we are searching for someone immediately available with a CMC background, specifically working on a Phase 2 drug.
Position Summary:
Responsible for managing the development and tracking of stage-appropriate testing methodology for drug substance and drug product, including in-process, release, stability, method validation and site transfer under aggressive timelines. Communicate and coordinate with internal Analytical, CMC, QA, Regulatory, Project Management and consultants, as well as with external CROs/CMOs counterparts. Manage critical analytical review of SOPs, test methods and specifications for raw materials/intermediates/drug substance/drug product, development/verification reports, validation protocols/reports, method transfers, COAs and stability summaries. Support contractor site investigations pertaining to OOS/OOT and deviations.
Job Responsibilities:
- Support Analytical (CMC) activities associated with the company’s global programs.
- Work closely with your Analytical Development colleagues and external CROs/CMOs collaborators to rapidly advance programs to key decision points, in preparation of regulatory submission, approval and post-approval commitments.
- Assist in determining analytical steps or solutions to solve current and future issues in a timely manner.
- Support analytical development strategies to ensure that project development timelines are in place and aligned with the project’s overall objectives.
- Actively participate in regulatory affairs processes & audits
- Perform data review & stability tracking
Preferred Qualifications:
- BS., MS., or PhD. in Organic Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field preferred.
- 5+ years’ experience in the contract research or pharmaceutical/biotech industry.
- Demonstrated abilities in the development and application of analytical assay, impurity, and in-vitro (dissolution) release
- Experience in high performance liquid chromatography and physicochemical properties (solubility, solid state, physical testing), methods development, drug substance and drug product.
- Knowledge of cGMP regulations, including compendial (USP, EP, JP) and guidance documents.
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Experience:
- Director
Remote Job:
- Yes
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 18, 2024
Company Overview

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