Analytical CMC Consultant

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Remote Job

Director

Posted 4 months ago
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
SciPro
SciPro

Current Openings: 0

SciPro (formerly Lawrence Harvey Life Sciences) is a people business. We specialise in sourcing, advising and introducing highly skilled life sciences candidates to our client partners across the globe, helping them to achieve their business goals. We provide talent on an executive level, contract, permanent and retained basis to SME, big Pharma businesses and incorporating CRO’s and consultancies across the Pharmaceutical, Biotech and Medical Device industries. Our consultants are technically aligned specialists focusing on a single area within Quality, Regulatory Affairs, Clinical Operations & Development, Data Management, Project Management, Medical Affairs, Pharmacovigilance, Market Access & HEOR, Research & Development and Biometrics. The art of recruitment isn't solely about filling jobs, it's about matching people with people and creating harmonious and successful working environments. As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it. Follow us on Twitter @SciProGlobal for latest news and updates.
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