Note: The job is a remote job and is open to candidates in USA. Fladger Associates is seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support external drug substance and drug product development programs. The role involves providing scientific leadership in analytical development and quality control, collaborating with cross-functional teams, and managing documentation workflow for regulatory submissions.

Responsibilities

• Duties: 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 Company
• 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)
• The successful candidate will collaborate with internal cross-functional teams and external partners (CDMOs/CROs) to ensure scientifically robust analytical strategies and clear, compliant CMC documentation aligned with global regulatory expectations
• 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
• Prepare and communicate clearly and independently technical plans, updates and deliverables as needed in the form of reports and/or presentations within the internal teams
• Partner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and quality events and ensure timely, compliant deliverables
• 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 inquiries

Skills

• Excellent employment opportunity for a Analytical SME & CMC Technical Writer in the Ridgefield, CT area
• 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 Company
• 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)
• The successful candidate will collaborate with internal cross-functional teams and external partners (CDMOs/CROs) to ensure scientifically robust analytical strategies and clear, compliant CMC documentation aligned with global regulatory expectations
• 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
• Prepare and communicate clearly and independently technical plans, updates and deliverables as needed in the form of reports and/or presentations within the internal teams
• Partner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and quality events and ensure timely, compliant deliverables
• 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 inquiries
• Advanced degree (e.g., PhD) is preferred, or Master's and Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, or related discipline
• 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.)
• 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
• Experience in global regulatory submissions (IND, CTA, NDA, MAA)
• Experience working with external manufacturing or testing partners

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