[Remote] Analytical Development Scientist

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.ResponsibilitiesDuties: 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 CompanyThis 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 expectationsProvide 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 managementContribute to development of DS/DP phase appropriate specifications and analytical control strategies in collaboration with internal and external teamsContribute 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 trialsIndependently propose or review quality agreement, SOW, study protocols/reports, batch/stability data, to support CMC deliverables in a timeline fashionPrepare and communicate clearly and independently technical plans, updates and deliverables as needed in the form of reports and/or presentations within the internal teamsPartner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and quality events and ensure timely, compliant deliverablesSupport departmental submission activities by managing documentation workflow workflow in Veeva RIM systemDemonstrated working experience in authoring, reviewing and editing (content and format) CTD Module 3 (Drug Substance and Drug Product) documents, in particular analytical related documentsContribute to preparation of regulatory submissions/briefings and responses to health authority inquiriesSkillsExcellent employment opportunity for a Analytical SME & CMC Technical Writer in the Ridgefield, CT areaWe 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 CompanyThis 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 expectationsProvide 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 managementContribute to development of DS/DP phase appropriate specifications and analytical control strategies in collaboration with internal and external teamsContribute 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 trialsIndependently propose or review quality agreement, SOW, study protocols/reports, batch/stability data, to support CMC deliverables in a timeline fashionPrepare and communicate clearly and independently technical plans, updates and deliverables as needed in the form of reports and/or presentations within the internal teamsPartner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and quality events and ensure timely, compliant deliverablesSupport departmental submission activities by managing documentation workflow workflow in Veeva RIM systemDemonstrated working experience in authoring, reviewing and editing (content and format) CTD Module 3 (Drug Substance and Drug Product) documents, in particular analytical related documentsContribute to preparation of regulatory submissions/briefings and responses to health authority inquiriesAdvanced degree (e.g., PhD) is preferred, or Master's and Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, or related disciplineSignificant working experience (>6 years) in pharmaceutical/biotech CMC and analytical development of NCE and NCE-like drug substance and solid and liquid formulationsDemonstrated working experience in regulatory submissionsFamiliarity with GMP and regulatory guidelines (e.g., ICH, FDA, EMA, USP, EP, etc.)Strong organization and technical writing skillsHigh attention to detail and scientific rigorEffective communication and stakeholder collaborationAbility to manage multiple priorities in a fast-paced environmentExperience in global regulatory submissions (IND, CTA, NDA, MAA)Experience working with external manufacturing or testing partnersCompany OverviewFladger Associates is a professional, national executive search and human capital solutions firm specializing in licensed, degreed, or certified professionals in: . It was founded in 1992, and is headquartered in Wilmington, Delaware, US, with a workforce of 11-50 employees. Its website is http://www.fladgerassociates.com.