Jobs

Description

This is a fully remote position but the candidate will need to be able to work east coast hours.

 The manager is looking for a candidate with experience in DP analytical and tech writing experience and DS analytical experience.

• We are seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support external drug substance (DS) and drug product (DP) development programs within External Alternative CMC development (EACD) at client.
• This contract role combines deep expertise in DS/DP analytical development and quality control to support ongoing DS/DP external CMC development and demonstrated familiarity of Veera RIM system and technical writing capabilities to support documentation and global regulatory submissions (e.g., IND, CTA, NDA/MAA).

Key Responsibilities

Analytical Expertise

• Provide scientific leadership in phase appropriate external DS/DP analytical development/QC for NCE and NCE-like (e.g., Oligonucleotide) entities, including method development, validation, transfer and lifecycle management
• Contribute to development of DS/DP phase appropriate specifications and analytical control strategies in collaboration with internal and external teams
• Contribute to development of DS/DP stability programs and assignment of DS retest period, DP shelf life and material holding times as needed, with internal and external teams to support FIH and following clinical trials
• Independently propose or review quality agreement, SOW, study protocols/reports, batch/stability data, to support CMC deliverables in a timeline fashion.

CMC Technical Writing

• Support departmental submission activities by managing documentation workflow workflow in Veeva RIM system
• Demonstrated working experience in authoring, reviewing and editing (content and format) CTD Module 3 (Drug Substance and Drug Product) documents, in particular analytical related documents.
• Contribute to preparation of regulatory submissions/briefings and responses to health authority inquirie

Required

• Significant working experience (>6 years) in pharmaceutical/biotech CMC and analytical development of NCE and NCE-like drug substance and solid and liquid formulations.
• Demonstrated working experience in regulatory submissions
• Familiarity with GMP and regulatory guidelines (e.g., ICH, FDA, EMA, USP, EP, etc.)

Key Skills

• Strong organization and technical writing skills
• High attention to detail and scientific rigor
• Effective communication and stakeholder collaboration
• Ability to manage multiple priorities in a fast-paced environment

Education:

• Advanced degree (e.g., PhD) is preferred, or Master's and Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, or related discipline