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Associate Director of Analytical Chemistry

Pacific BioLabs
Hercules, CA
Closing date
Nov 26, 2021

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Science, Chemistry, Analytical Chemistry
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Pacific BioLabs is an independent CRO offering cGMP/GLP testing services in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. Founded in 1982, PBL is beginning a new chapter, applying significant investment and energy towards modernizing workflows, upgrading facilities and most importantly, enhancing our employee experience. We are looking for talented, energetic scientists and professionals to share in our passion for our mission to enhance public health through the testing services we provide to our pharma, biotech and medical device clients. If you are up for a challenge, come join our team!

PBL has an immediate opening for full time Associate Director in the Analytical Services Department. As a member of the PBL Analytical Chemistry team, the Associate Director of Analytical Chemistry will make significant contributions to the management and growth of the department primarily in the areas of HPLC, LC-MS and GC disciplines in support of company and client needs. This includes implementation of new/current technologies and instrumentation to enable efficient laboratory operations. The Associate Director of Analytical Chemistry will be responsible for the preparation and review of departmental Standard Operating Procedures, method validation and stability studies, raw data, results summaries, and final reports in support of client product development. The individual will be expected to be highly knowledgeable in order to independently address and resolve complex analytical chemistry problems and to demonstrate the ability to be compliant with GLP/cGMP guidance's and industry best practices. Additionally, the individual will have supervision/mentor and leadership responsibilities within the department.

Supervising and mentoring of Analytical Chemistry personnel in several aspects of department operations including reporting, method validation/qualification, investigating deviations, and unexpected results
Developing, validating, and standardizing complex GC, GC/MS, HPLC, LC/MS analytical methods for isolation, detection, identification, and quantification of both drug substances and drug products of small molecules or/and large molecules
Analyzing and evaluating material and products at all stages of development process under stringent quality and time requirements
Independent preparation of client reports, invention disclosures, and Standard Operating Procedures for internal and external use
Reviewing data for technical content and regulatory compliance
Remaining current with the analytical chemistry literature and champions the implementation of new technologies
Ensuring analytical equipment is maintained in good working order; troubleshooting and performing minor repairs as needed
Anticipating additional resources, consumable, and equipment requirements as needed to ensure that work can be completed within the budgeted time
Maintaining a safe and orderly laboratory and insurance of compliance with all safety policies and practices
Collaborating with Analytical Senior Management in the growth and development of the department
Salary will be commensurate with education and experience. A benefits package including medical, dental and 401(k) is also offered.

A Ph.D. in Chemistry, Pharmaceutical Sciences or equivalent with over 8 years of analytical chemistry experience preferred. Candidates with a Master's Degree with over 8-10 years of relevant experience will also be considered
Candidates with applicable knowledge of HPLC, GC, LC/MS, GC/MS, FTIR, UV-Vis, KF and other compendial methods will be given preference
Candidates with applicable knowledge and experience in pharmaceutical/medical device extractable and leachable testing highly desired
Working knowledge of cGMP/GLP requirements, ICH, FDA, USP and other pharmaceutical industry regulatory guidelines highly desired
Candidates with industry experience in CMC and CMC regulatory requirements (e.g., CMC sections supporting IND and NDA applications) desired
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 chromatography techniques and analytical instruments including GC, GC/MS, HPLC, and LC/MS
Exhibit strong technical skills and the ability to critically evaluate raw data and results without supervision
Must be skilled in operation of chromatographic data acquisition and processing software packages such as Agilent ChemStation and other software tools for data reduction and presentation
Experience in the operation, minor maintenance, troubleshooting, and calibration of laboratory equipment required
Excellent written, reporting, and verbal communication skills required
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 supporting department and client deliverables under tight deadlines
Able to lift 10 - 25 pounds

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