Sr Scientist - Analytical Development

Welcome to the Tarsanet Internal Career Center!; Irvine (CA); Hybrid; USD 120,000 - 168,000; Full time

Benefits offered by this job

Bonus

Stock options

Comprehensive benefits

Job summary

Tarsanet in Irvine, CA seeks a Sr. Scientist, Analytical Development to lead analytical activities supporting clinical and commercial development programs.

You will develop methods, validate studies, and contribute to regulatory CMC submissions while coordinating with cross-functional teams. You will oversee external labs, apply advanced techniques (HPLC/UPLC, MS, dissolution), and drive risk assessments, method transfer, and control strategy development to ensure product quality and regulatory

Qualifications

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related field with 4+ years of pharma/biotech experience.
• MS with 8–12 years of relevant pharma/biotech experience also acceptable.
• Experience supporting analytical development activities for Phase I–III programs.
• Experience with sterile or complex dosage forms preferred.
• Experience with extractables/leachables, elemental impurities, and forced degradation desirable.
• Experience managing CROs, CDMOs and external labs; regulatory CMC documentation experience.
• Strong understanding of QbD, risk-based development, and control strategies; familiarity with ICH, FDA, cGMP, and CMC guidelines.

Responsibilities

• Develop and execute analytical development plans aligned with CMC milestones and regulatory timelines.
• Design, qualify, transfer, and validate analytical methods for drug substances/products and materials.
• Lead analyses risk assessments and help develop phase-appropriate control strategies.
• Oversee external labs, CROs, and CDMOs to ensure timely, high-quality analytical deliverables.
• Interpret stability data and support regulatory submissions with technical documentation.
• Collaborate with Regulatory, Clinical Supply, QA, and Manufacturing.
• Stay current with analytical technologies and regulatory expectations.

Skills

Analytical development

Regulatory knowledge

CRO/CDMO management

QbD

Risk assessment

Cross-functional collaboration

Analytical method development

Education

PhD in Analytical Chemistry

MS with 8–12 years experience

Job description

Thanks for your interest in this position. If this role aligns with your career goals, please connect with your manager and HRBP to discuss how your experience and skills fit the position. If everything is a go, apply and the Talent Acquisition team will contact you for an interview.

- Your Human Resources Team

About the Role

The Sr. Scientist, Analytical Development leads analytical activities supporting clinical‑stage drug substance and drug product development programs. This role provides phase‑appropriate analytical development, validation, and analytical CMC regulatory support to ensure successful advancement of development candidates through clinical and commercial milestones. The scientist develops analytical methods, conducts risk assessments, and creates control strategies for drug substance, drug product, excipients, impurities, degradation products, and critical quality attributes. The individual serves as a key technical contributor and cross‑functional partner while overseeing external laboratories and development organizations.

Key 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.
• Provide technical oversight and strategic direction to external analytical laboratories, CROs, and CDMOs to ensure timely and high‑quality execution of analytical deliverables.
• Identify critical analytical challenges, lead technical problem‑solving efforts, and support root‑cause investigations for OOS/OOT and product quality issues.
• Apply advanced analytical techniques such as HPLC/UPLC, GC, MS, LC‑MS, dissolution, Karl Fischer titration, spectroscopy, particle characterization, and compendial methods as appropriate.
• 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.
• Contribute to analytical CMC sections of IND, CTA, NDA, and other regulatory submissions.
• Ensure analytical activities are conducted in compliance with applicable regulatory requirements, compendial standards, and company quality systems.
• Review and approve analytical methods, method validation documents, release testing data, and stability results for drug products and drug substances.
• Collaborate closely with Regulatory, Clinical Supply, Quality Assurance, Manufacturing, and external partners to ensure alignment of analytical activities with program objectives.
• Stay current with emerging analytical technologies, regulatory expectations, and industry best practices and incorporate them into development strategies where appropriate.

Factors for Success

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline with 4+ years of relevant pharmaceutical or biotechnology industry experience; or
• 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.
• Strong understanding of Quality by Design (QbD), risk‑based analytical development, and control strategy development.
• Working knowledge of ICH, compendial, FDA, cGMP, and CMC guidelines and industry best practices.

Tarsans are also expected to exemplify our core leadership competencies, including:

• Decision Making – Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome‑oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions.
• Collaboration and Team Building – Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.
• Outcome Driven – Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met.

A Few Other Details Worth Mentioning

• The position will be based in our Irvine office, which offers onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment.
• We are passionate about our culture and live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact.
• This position reports directly to the Director, Analytical Development.
• Travel will be required, up to 30%, including international travel.

The expected base pay range for this position is $120,000 – $168,000 plus bonus, stock equity, and comprehensive benefits. Our benefits include health, dental, and vision insurance, as well as generous paid time off, holiday, and personal days.