[Remote] Analytical Development Scientist
Note: The job is a remote job and is reputed company to candidates in USA. Fladger Associates is seeking an reputed company Analytical Subject Matter Expert (SME) and CMC Technical reputed company to support external drug reputed company and drug product development programs. The role involves providing scientific leadership in analytical development and reputed company control, collaborating with cross-functional teams, and managing documentation workflow for regulatory submissions.
Responsibilities
- Duties: We are seeking an reputed company Analytical Subject Matter Expert (SME) and CMC Technical reputed company to support external drug reputed company (DS) and drug product (DP) development programs reputed company External Alternative CMC development (EACD) at Company
- This contract role combines deep expertise in DS/DP analytical development and reputed company 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 reputed company, compliant CMC documentation reputed company with global regulatory expectations
- reputed company 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 reputed company teams
- Contribute to development of DS/DP stability programs and assignment of DS retest period, DP reputed company life and material holding times as needed, with reputed company teams to support FIH and following reputed company
- Independently propose or review reputed company agreement, SOW, study protocols/reports, batch/stability data, to support CMC deliverables in a reputed company fashion
- Prepare and communicate reputed company and independently technical plans, updates and deliverables as needed in the reputed company of reports and/or presentations reputed company the internal teams
- Partner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and reputed company events and ensure reputed company, compliant deliverables
- Support departmental submission activities by managing documentation workflow workflow in reputed company RIM system
- Demonstrated working experience in authoring, reviewing and editing (content and format) CTD Module 3 (Drug reputed company and Drug Product) documents, in particular analytical reputed company documents
- Contribute to preparation of regulatory submissions/briefings and responses to health authority inquiries
Skills
- Excellent employment opportunity for a Analytical SME & CMC Technical reputed company in the Ridgefield, CT area
- We are seeking an reputed company Analytical Subject Matter Expert (SME) and CMC Technical reputed company to support external drug reputed company (DS) and drug product (DP) development programs reputed company External Alternative CMC development (EACD) at Company
- This contract role combines deep expertise in DS/DP analytical development and reputed company 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 reputed company, compliant CMC documentation reputed company with global regulatory expectations
- reputed company 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 reputed company teams
- Contribute to development of DS/DP stability programs and assignment of DS retest period, DP reputed company life and material holding times as needed, with reputed company teams to support FIH and following reputed company
- Independently propose or review reputed company agreement, SOW, study protocols/reports, batch/stability data, to support CMC deliverables in a reputed company fashion
- Prepare and communicate reputed company and independently technical plans, updates and deliverables as needed in the reputed company of reports and/or presentations reputed company the internal teams
- Partner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and reputed company events and ensure reputed company, compliant deliverables
- Support departmental submission activities by managing documentation workflow workflow in reputed company RIM system
- Demonstrated working experience in authoring, reviewing and editing (content and format) CTD Module 3 (Drug reputed company and Drug Product) documents, in particular analytical reputed company 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 reputed company, Pharmaceutical Sciences, or reputed company discipline
- Significant working experience (>6 years) in pharmaceutical/biotech CMC and analytical development of NCE and NCE-like drug reputed company 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
reputed company