Senior Scientist I, Analytical Development

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

Job summary

A leading biotech firm in California is seeking a Senior Scientist I for Analytical Development. The candidate will support various analytical testing and method development activities. A PhD in Chemistry or relevant field is required, along with a strong understanding of regulatory standards and proficiency in analytical techniques. This position is contract-based with a pay range of $124,800 - $145,600 annually.

Qualifications

• Minimum of 5 years of industry experience for PhD candidates.
• Understanding of ICH guidelines and FDA/EMA regulations.
• Proficiency in key analytical methods.

Responsibilities

• Support analytical development activities at contract organizations.
• Serve as a technical SME for analytical methods.
• Prepare and review necessary protocols and documents.

Skills

Analytical techniques

Data interpretation

Problem-solving

Cross-functional collaboration

Technical writing

Education

PhD in Chemistry or related field

MS with 8+ years experience

Tools

HPLC

UPLC

LC-MS

XRPD

Dissolution testing

Job description

Senior Scientist I, Analytical Development

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Bayside Solutions provided pay range

This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $70.00/hr

Senior Scientist I, Analytical DevelopmentW2 Contract-to-HireSalary Range: $124,800 - $145,600 per yearLocation: Redwood City, CA - Onsite Role

Duties and Responsibilities:

• Support analytical development and testing activities conducted at contract organizations (CMOs/CROs), including method development, method qualification/validation, and release/stability testing.
• Serve as a technical subject matter expert (SME) for analytical methods, ensuring that outsourced activities meet quality standards and project timelines.
• Review and 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 ensure analytical alignment with project goals and regulatory expectations.

Requirements and Qualifications:

• PhD in Chemistry, Pharmaceutical Sciences, or a related field with a minimum of 5 years of relevant industry experience; or MS with 8+ years of experience in analytical development.
• Proficiency in analytical techniques such as HPLC/UPLC, LC-MS, XRPD, dissolution testing, DSC, DVS, and compendial methods (e.g., USP/EP).
• Understanding of ICH guidelines (e.g., Q2, Q6A, Q3A, B, C, D, M7), FDA/EMA regulatory expectations, and phase-appropriate analytical development.

Preferred Qualifications:

• Strong data interpretation and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to translate complex scientific concepts into clear documentation.

Desired Skills and Experience

analytical development, method development, method qualification, method validation, release testing, stability testing, CMO management, CRO management, technical subject matter expertise, data interpretation, method validations, characterization studies, drug substance analysis, drug product analysis, protocol preparation, regulatory submission documents, IND, NDA, MAA, IMPD, Quality collaboration, Regulatory collaboration, HPLC, UPLC, LC-MS, XRPD, dissolution testing, DSC, DVS, compendial methods, USP, EP, ICH guidelines, Q2, Q6A, Q3A, Q3B, Q3C, Q3D, M7, FDA regulations, EMA regulations, phase-appropriate analytical development, problem-solving, scientific documentation, technical writing, cross-functional collaboration, outsourced activity management, analytical method expertise, Chemistry, Pharmaceutical Sciences

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Research and Science

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