III, Analytical Services

Pacific BioLabs•Hercules, CA

7h•$63,000 - $90,000

About The Position

Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. We are currently seeking energetic scientists and professionals to support our clients in the pharmaceutical, biotech, and medical device fields. Join us in our mission to improve public health through science! The Associate Scientist I/II/III will develop and validate HPLC, LC/MS, GC, GC/MS, ICP-MS, ELISA, and/or MSD methods, provide hands-on technical assistance to maintain analytical equipment in good working order, and analyze samples supporting various projects. The position requires independent preparation and review of SOPs/Methods, method validation, the ability to critically review raw data with moderate to no supervision, generation of result summaries and final reports. Prior knowledge of and at least 3 years working in a GMP environment is required.

Requirements

At a minimum, a BSc. in Chemistry or equivalent is required. Higher degree is preferred.
A minimum of 3-7 years of industrial experience with hands-on experience in a GMP analytical laboratory.
A good understanding of analytical chemistry.
Demonstrated practical ability to develop methods for isolation, characterization, and quantification of both drug substances and drug products of small molecules or/and large molecules using conventional techniques and analytical instruments including HPLC, LC/MS, ICP-MS, GC, GC/MS, ELISA, and/or MSD.
A minimum of 3 years working in a cGMP and/or GLP environment is required.
Must be skilled in the operation of data acquisition and processing software packages such as Agilent ChemStation, OpenLab, and other software tools for data reduction and presentation.
Excellent written, reporting, and verbal communication skills.
Proficient in using Microsoft Office suite including Word, Excel, and Power Point.
Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities
Must be highly motivated and capable of working independently or under minimal supervision to deliver results under tight deadlines.
Able to lift 10 – 25 pounds.

Nice To Haves

Experience with the development of bioanalytical methods is a plus.
Experience/knowledge of cGMP/GLP procedures would be a plus.
Candidates with hands-on experience in the operation of Sciex LC/MS/MS are preferred.

Responsibilities

Developing, validating, and standardizing HPLC, LC/MS, ICP-MS, GC, GC/MS, ELISA or/and MSD analytical methods for isolation, detection, identification, and quantification of both drug substances and drug products of small molecules or/and large molecules.
Review of data for technical content and regulatory compliance.
Analysis and evaluation of material and products at all stages of development process under stringent quality and time requirements.
Preparation of final reports, invention disclosures, and Standard Operating Procedures for internal and external use.
Ensuring analytical equipment is maintained in good working order; troubleshoots and performs minor repairs as needed.
Anticipating additional resources, consumable, and equipment requirements as needed to ensure that work can be completed within the budgeted time.
Maintenance of a safe and orderly laboratory and insurance of compliance with all safety policies and practices.
Remaining current with the analytical chemistry literature and champions the implementation of new technology.