Senior Scientist Analytical Chemistry

Senior Scientist - Mass Spectrometry

Company Overview:

We are a leading Contract Research Organization (CRO) based in the vibrant San Francisco Bay Area, specializing in providing comprehensive scientific solutions for pre-clinical drug development, IND submissions, and drug substance and product analysis within the life science industry.

Position Overview:

As the Associate Director of Mass Spectrometry for Biopharmaceuticals, you will play a pivotal role in our organization. Your primary responsibilities will revolve around developing and validating cutting-edge High Resolution Mass Spectrometry methods for the analysis of large molecule biopharmaceutical products. This will include conducting mass spectrometry-based characterization of various biologic drugs, such as mAbs, ADCs, BiTEs, and more, on behalf of our sponsors. Additionally, you will collaborate with our Business Development team to assist in proposal development for clients. In this position, you will oversee critical aspects of our lab operations, including designing and implementing mass spectrometry strategies for characterizing, elucidating the structure, and assessing the quality of biopharmaceuticals, such as mAbs and recombinant proteins, in both research and development (R&D) and Good Laboratory Practice (GLP)/current Good Manufacturing Practice (cGMP) environments.

We are seeking an experienced scientist with in-depth knowledge and expertise in the development of biologic drugs. As part of this role, you will provide strategic direction to project teams and support our Analytical Chemistry Business Unit and Management. Leveraging state-of-the-art mass spectrometry techniques, you will be instrumental in advancing our biopharmaceutical development and characterization programs to meet the demands of our expanding client project pipeline. This position reports directly to the Director of Chemistry.

Essential Job Functions:

• Develop, assess feasibility, qualify, and validate methods primarily using High Resolution Mass Spectrometry for large molecule biopharmaceutical products.
• Perform protein analysis, including determining primary structure and interpreting secondary, tertiary, and quaternary structure data.
• Conduct peptide mapping analysis to detect and characterize post-translational modifications (PTMs), profile sequences, and confirm sequence information.
• Carry out glycan analysis, including profiling, quantification, and elucidation.
• Experience with protein quantification using enzyme-linked immunosorbent assay (ELISA) is a plus.
• Troubleshoot method and instrument challenges.
• Collaborate with clients, providing scientific expertise, answering questions, and delivering regular project updates.
• Work closely with the Business Development team to define project scopes, contribute to budgetary planning, establish project timelines, and anticipate technical challenges.
• Actively participate in client meetings and preliminary discussions to understand client requirements and provide technical guidance.
• Ensure study design and management adhere to protocols, amendments, planned changes, standard operating procedures (SOPs), and all applicable regulatory requirements (e.g., GLP, GCP, ICH).
• Serve as the main point of contact for project directors and scientific teams once projects are initiated.
• Effectively organize and communicate complex data sets to key stakeholders with diverse backgrounds.
• Review and approve reports or reporting of results within study timelines, ensuring accurate representation and appropriate documentation of any deviations or exception events.
• Demonstrate the ability to prioritize responsibilities and multitask in a fast-paced environment with shifting priorities.
• Foster collaborative and cooperative relationships with all company functions and senior staff to achieve the company's vision.
• May supervise team members within the 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 closely related field.
• Extensive experience in protein sciences, biologic drugs, and large molecule characterization.
• 4-6 years of experience in the pharmaceutical industry.
• Proficiency in operating chromatographic data acquisition and processing software packages, such as BioPharma Finder and Compound Discoverer.
• Full-time, on-site position (Monday - Friday, 9:00 am - 5:00 pm).
• Strong analytical background with knowledge of cGMPs, ICH, relevant FDA guidelines, and experience in writing regulatory submissions.
• Exceptional team player with excellent oral and written communication skills.
• Ability to interpret data, troubleshoot issues, and provide recommendations for next steps.
• Familiarity with relevant laboratory techniques within a regulated environment.
• Demonstrated proficiency in hands-on analytical work while effectively managing internal and external activities.
• Exhibit strong technical skills and the ability to critically evaluate raw data and results independently.

Contact Us:

We are ready to offer a sign-on bonus and relocation package to the selected candidate. We provide a competitive compensation and benefits package, including coverage of 90% of health, dental, and vision premiums, a 401k retirement plan with company contribution, and monthly performance bonuses. Additionally, we offer a flexible and generous paid time off policy.

Job Type: Full-time

Pay: $140,000.00 - $165,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Alameda, CA 94501: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Analytical chemistry: 5 years (Required)

Work Location: In person