Benefits:

401(k)

401(k) matching

Bonus based on performance

Dental insurance

Free food & snacks

Health insurance

Wellness resources

Position Summary:

Crystal Bio Solutions is a CRO providing advanced analytical services for biological drug discovery and development area. Our clients include multinational pharmaceutical companies and biotech companies.

The company focuses on analytical and bioanalytical services for biologics in CMC development with further extension to support pre-clinical and clinical analysis. The team has successfully supported non-GLP, GLP (non-clinical) and GCLP (clinical) projects. The role is mainly responsible for non-GLP CMC support for both pre-clinical and clinical projects and partnering with our clients for project success.

Key Responsibilities:

Independently conduct LC-MS method development for biologics (e.g., ADC, mAb, protein, peptide, oligonucleotide, etc.) in support of developability assessment, comparability assessment, in-depth characterization, biotransformation, and CQA related analysis.

Present and interpret data internally and/or externally as needed.

Serve as Subject Matter Expert (SME) for LCMS platform.

Serve as the Principal Investigator responsible for interaction with the client from the study design to scheduling, conducting, reporting, and transferring data. Ensure responsiveness to the client, timely delivery, and overall customer satisfaction.

Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.

Assist in establishing and improving policies, procedures, work instructions and SOPs.

Understand and adhere to corporate standards regarding code of conduct and Environment Health & Safety (EHS).

Perform other related duties as assigned.

Qualifications & Educational Requirements:

Ph.D., M.S., in Chemistry, Biochemistry or related scientific fields required, including a minimum of 4+(Ph.D.) or 9+(Master’s) years of CRO/Pharma/Biotech experience.

Hands-on experience with high-resolution LCMS method development and in-depth characterization.

Supervisory experience in both project and talent (people) management is preferred.

Ability to work independently and pay good attention to details.

Ability to achieve objectives/timelines through collaborative efforts with co-workers, managers, and clients.

Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused.

Effective writing and communication skills.