Senior Scientist - Bioanalysis

Emery Pharma
Alameda County, CA

About Emery Pharma

 

Emery Pharma is a full-service Contract Research Organization (CRO) that delivers scientific solutions to accelerate pre-clinical drug development, support IND submissions, and enable drug substance and drug product analysis. Emery Pharma is located in the San Francisco Bay Area, focused on providing scientific solutions for the life science industry.

 

Position Overview

 

Emery Pharma is seeking an accomplished Senior Scientist, bioanalysis to lead and expand our bioanalytical capabilities. This individual will bring deep expertise in small-molecule LC-MS/MS (Agilent platforms) and meaningful experience in large-molecule bioanalysis. HRMS experience is a plus.


We are specifically seeking someone who has worked across both small- and large-molecule modalities, but small-molecule experience and mass spectrometry expertise are essential. The ideal candidate has extensive hands-on experience in bioanalytical method development, validation, and sample analysis. They will bring deep technical expertise in performing and troubleshooting LC-MS/MS methods and a strong track record of working in GLP and cGMP environments. This individual excels at problem-solving, can swiftly identify and resolve analytical challenges, and possesses outstanding communication and report-writing skills. They are equally comfortable at the bench and in front of clients—capable of explaining complex data clearly, building strong scientific relationships, and serving as a trusted partner to sponsors and cross-functional teams. This position will collaborate cross-functionally with the Business Development and Quality Assurance teams. 


 Essential Job Functions

·      Lead scientific and operational strategy for small- and large-molecule bioanalytical programs, with primary emphasis on small-molecule LC-MS/MS.

·      Oversee method development, qualification, validation, and sample analysis in compliance with GLP and ICH M10 guidelines.

·      Develop and troubleshoot LC-MS/MS assays on Agilent systems (MassHunter) for pharmacokinetics, metabolite ID, and biomarker quantitation.

·      Develop non-compartmental pharmacokinetic (PK) analysis reports and other regulatory documentation to support client submissions (e.g., IND, NDA, BLA filings).

·      Interpret and communicate PK data and study findings to clients and regulatory stakeholders, providing scientific insight and guidance throughout the submission process.

·      Serve as a scientific subject matter expert (SME) for clients, regulatory auditors, and internal staff.

·      Collaborate with the Business Development team to define project scopes, budgets, and timelines; support proposal development and client presentations.

·      Manage and mentor a multidisciplinary scientific team; oversee resource planning, scheduling, and instrument strategy.

·      Review and approve study plans, validation protocols, and reports for technical and regulatory accuracy.

·      Partner with QA and senior leadership to ensure inspection readiness and continuous improvement of GLP-compliant operations.

·      Represent Emery Pharma at scientific meetings, client discussions, and industry conferences.

·      Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities.

·      Work interactively and cooperatively with all functions of the company and with senior staff to help achieve the company’s vision.

·      May supervise team members within work group.

·      These job requirements are not intended to be construed as an exhaustive list of all  responsibilities, duties, and skills required of personnel.

 

 

 

Requirements

 

·      Ph.D. in Analytical Chemistry or very closely related field is required.

·      5+ years of bioanalytical experience in pharma/biotech/CRO settings, with deep expertise in small-molecule LC-MS/MS.

·      Demonstrated proficiency with Agilent LC-MS/MS platforms and MassHunter.

·      Strong command of GLP, ICH M10, and relevant FDA/EMA guidance; experience supporting regulatory submissions (IND/CTA; NDA/BLA contributions a plus).

·      Excellent communication, client-facing presence, and proven ability to interpret complex datasets, troubleshoot, and drive decisions in fast-paced environments.

·      Hands-on mindset with the ability to lead scientifically while managing internal/external activities and multiple concurrent studies.

·      Position is onsite full-time, Monday - Friday 9:00 am - 5:00 pm

·      Candidate should be a strong team player with excellent oral and written communication skills and with a demonstrated ability to interpret data, troubleshoot, and suggest next steps

·      Appropriate technical experience of relevant laboratory techniques within a regulated environment.

·      Proficiency in hands-on analytical work while managing internal and external activities.

·      Exhibit strong technical skills and the ability to critically evaluate raw data and results without supervision.

 

Contact Us

 

We are prepared to offer the candidate a sign-on bonus and relocation package. Emery Pharma has a competitive compensation and benefit package including 90% of health, dental, and vision premiums, 401k retirement plan with company contribution, and quarterly performance bonuses. Company offers a paid/flexible time off policy.

Please send resume /C.V. with a cover letter to: careers@emerypharma.com

 

Emery Pharma is an equal opportunity employer.

 

 

 

 

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