Note: The job is a remote job and is open to candidates in USA. VARITE INC is a global, research-driven pharmaceutical company focused on developing innovative medicines. They are seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support drug substance and drug product development programs, ensuring compliance with regulatory requirements and collaborating with internal and external teams.
Responsibilities
- 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
- 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
- Advanced degree (e.g., PhD) is preferred, or Master's and Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, or related discipline
Benefits
- Health Insurance: Medical, dental, and vision coverage
- Retirement Plans: Participation in a company-sponsored retirement savings plan.
- Legal Service Plans: Offering access to attorneys for legal advice and representation.
- Employee referral bonus
Company Overview
VARITE has a definite spirit. It was founded in 2000, and is headquartered in San Jose, California, US, with a workforce of 1001-5000 employees. Its website is http://www.varite.com.