Director, Bioanalytical Development

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Job description

Description:

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 pharma, biotech and medical device clients. If you are up for a challenge, come join our team!

Pacific BioLabs has an immediate opening for full time Director, Bioanalytical Development in the Analytical Chemistry Department. As a member of the PBL Analytical Chemistry team, the Director, Bioanalytical Development will make significant contributions to the growth of the department primarily in the areas of MSD, ELISA, CE, West Blot, HPLC, and LC-MS disciplines in support of company and client needs. This includes implementation of new/current technologies and instrumentation to enable efficient laboratory operations. The Director, Bioanalytical Development 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 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.

Primary responsibilities for the Director, Bioanalytical Development include but are not limited to:

• Develops, validates, and standardizes complex MSD, ELISA, CE, West Blot, HPLC, and LC-MS analytical methods for isolation, detection, identification, and quantification of both drug substances and drug products of small and/or large molecules
• Analyzes and evaluates material and products at all stages of development process under stringent quality and time requirements
• Independently prepares client reports, invention disclosures, and Standard Operating Procedures for internal and external use
• Reviews data for technical content and regulatory compliance
• Remains current with the analytical chemistry literature and champions the implementation of new technology
• Ensures analytical equipment is maintained in good working order; troubleshoots and performs minor repairs as needed
• Anticipates additional resources, consumable, and equipment requirements as needed to ensure that work can be completed within the budgeted time
• Maintains a safe and orderly laboratory and insures compliance with all safety policies and practices
• Supervises and mentors Analytical Chemistry personnel in several aspects of department operations including reporting, method validation/qualification, and investigating deviations and unexpected results
• Collaborates with Analytical Senior Management in the growth and development of the department

. Requirements:

Qualifications and Skills of Director, Bioanalytical Development

Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or equivalent with over 10 years of bioanalytical chemistry experience preferred. Candidates with a Master's degree with over 12-15 years of relevant experience will also be considered.

• Knowledge of MSD, ELISA, CE, West Blot, HPLC, LC-MS, and other compendial methods
• Working knowledge of cGMP/GLP requirements, ICH, FDA, USP, and other pharmaceutical industry regulatory guidelines
• Industry experience in CMC and CMC regulatory requirements (e.g., CMC sections supporting IND and NDA applications)
• Demonstration of practical ability to develop methods for isolation, characterization, and quantification of both drug substances and drug products of small and/or large molecules using conventional chromatography techniques and analytical instruments including MSD, ELISA, CE, West Blot, HPLC, and LC-MS
• Strong technical skills and the ability to critically evaluate raw data and results without supervision
• Skilled in operation of chromatographic data acquisition and processing software packages such as Agilent ChemStation and other software tools for data reduction and presentation
• 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
• Excellent verbal and written communication skills
• Proficient in Microsoft Office
• Able to lift 10 - 25 pounds

Salary will be commensurate with education and experience. A benefits package including medical, dental and 401(k) is also offered.

Pacific BioLabs is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans status, or any other legally-protected factors.

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