[Remote] Analytical Development SME (Small Molecules)

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.ResponsibilitiesProvide 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 inquiriesSkillsSignificant 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 partnersAdvanced degree (e.g., PhD) is preferred, or Master's and Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, or related disciplineBenefitsHealth Insurance: Medical, dental, and vision coverageRetirement Plans: Participation in a company-sponsored retirement savings plan.Legal Service Plans: Offering access to attorneys for legal advice and representation.Employee referral bonusCompany OverviewVARITE 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.