Senior Scientist I, Analytical Development

Bayside Solutions; California (MO); On-site; USD 124,800 - 145,600; Full time

Job summary

A premier life sciences staffing firm seeks a Senior Scientist I for Analytical Development in Redwood City. This position requires a PhD with at least 5 years of relevant experience or a Master's with 8 years. The ideal candidate will have strong expertise in small-molecule analytical development, proficiency in various analytical techniques, and understanding of regulatory expectations. Responsibilities include supporting method development and collaborating with cross-functional teams. This is an onsite role requiring 3-4 days a week in the lab.

Qualifications

• PhD with at least 5 years in small-molecule analytical development.
• Master's degree with at least 8 years of relevant experience.
• Proficient in analytical methods and ICH guidelines.

Responsibilities

• Support analytical development and testing activities with contract organizations.
• Serve as technical SME for ensuring quality standards.
• Review and interpret data for method validations and release testing.
• Prepare and review protocols and regulatory submission documents.
• Collaborate with Quality and Regulatory teams.

Skills

HPLC/UPLC

LC-MS

Data interpretation

Problem-solving

Excellent communication

Education

PhD with minimum 5 years experience or Master's with minimum 8 years experience

Tools

Analytical techniques

Job description

Senior Scientist I, Analytical Development

W2 Contract-to-Hire

Salary Range: $124,800 - $145,600 per year (Base pay: $60.00/hr - $70.00/hr)

Location: Redwood City, CA - Onsite Role

Requirements and Qualifications:

• Must be onsite 3‑4 days a week.
• PhD with a minimum of 5 years of relevant experience, OR Master’s with a minimum of 8 years of experience.
• 5+ years in small‑molecule analytical development and method development.
• Experience in CMC.
• Proficiency in analytical techniques: HPLC/UPLC, LC‑MS, XRPD, dissolution testing, DSC, DVS, compendial methods (USP/EP).
• Understanding of ICH guidelines (Q2, Q6A, Q3A, B, C, D, M7) and FDA/EMA regulatory expectations.

Preferred Qualifications:

• Strong data interpretation and problem‑solving skills.
• Excellent written and verbal communication; ability to translate complex scientific concepts into clear documentation.

Duties and Responsibilities:

• Support analytical development and testing activities at contract organizations (CMOs/CROs): method development, qualification/validation, release/stability testing.
• Serve as technical SME for analytical methods, ensuring outsourced activities meet quality standards and project timelines.
• Review/interpret data from method validations, release testing, and characterization studies for drug substance (DS) and drug product (DP).
• Prepare, review, and/or approve protocols, reports, and regulatory submission documents (IND, NDA/MAA, IMPD).
• Collaborate cross‑functionally with Quality, Regulatory, and external partners to align analytical work with project goals and regulatory expectations.