itcss
Sr Scientist - Analytical Development
Irvine, California, United States · Senior
Sponsorship not specified$120k-$168kDetected 16 days ago
RecruitingHRGMPFDA RegulatoryMass SpectrometryLeadershipCollaborationProblem Solving
About the role
- Provide technical oversight and strategic direction to external analytical laboratories, CROs, and CDMOs to ensure timely and high-quality execution of analytical deliverables.
- Apply advanced analytical techniques such as HPLC/UPLC, GC, MS, LC-MS, dissolution, Karl Fischer titration, spectroscopy, particle characterization, and compendial methods as appropriate.
- Contribute to analytical CMC sections of IND, CTA, NDA, and other regulatory submissions.
Responsibilities
- Develop and execute analytical development plans aligned with CMC milestones, clinical timelines, regulatory requirements, and overall product development strategy
- Design, develop, optimize, qualify, validate, and transfer analytical methods for drug substance, drug product, raw materials, in-process controls, and stability testing in accordance with ICH, FDA, USP, and cGMP requirements.
- Lead analytical risk assessments and contribute to development of phase-appropriate analytical control strategies.
- Design and oversee laboratory studies and independently execute critical experiments supporting method development, validation, characterization, and investigations.
- Support specification development and justification through scientific evaluation of analytical and stability data.
- Serve as the analytical lead for assigned development programs and provide scientific leadership across cross-functional project teams.
- Identify critical analytical challenges, lead technical problem-solving efforts, and support root-cause investigations for OOS/OOT and product quality issues.
- Interpret, trend, and communicate stability data to support specification setting, shelf-life assignments, product quality assessments, and regulatory submissions.
- Author, review, and approve analytical development reports, specifications, and technical documents.
- Review and approve analytical methods, method validation documents, release testing data, and stability results for drug products and drug substances.
Requirements
- Travel will be required, up to 30%, including international travel.
Nice to have
- PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline with 4+ years of relevant pharmaceutical or biotechnology industry experience
- MS degree with 8-12 years of relevant pharmaceutical or biotechnology industry experience.
- Demonstrated experience supporting analytical development activities for Phase I-III clinical development programs.
- Experience with small peptides is a plus.
- Experience with sterile, ophthalmic, injectable, or other complex dosage forms preferred
- Experience with extractables/leachables, elemental impurities, forced degradation, characterization studies, and bioanalytical methods is desirable
- Experience managing CROs, CDMOs and external analytical laboratories
- Proven experience authoring and reviewing analytical CMC documentation for regulatory submissions
Skills
- Your Human Resources Team
Compensation
- The expected base pay range for this position is $120,000 - $168,000 plus bonus, stock equity, and comprehensive benefits.
Benefits
- The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.
Company info
- Ensure analytical activities are conducted in compliance with applicable regulatory requirements, compendial standards, and company quality systems.
- We are passionate about our culture!
- Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
This listing is sourced directly from itcss's careers page and normalized into a canonical job model.