ASSOCIATE DIRECTOR, ANALYTICAL CHEMISTRY

PBL has an immediate opening for full time Associate Director in the Analytical Chemistry Department. As a member of the PBL Analytical Chemistry team, the successful candidate 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 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, 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 INCLUDE BUT ARE NOT LIMITED TO

  • 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

QUALIFICATIONS AND SKILLS

  • 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

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 veteran status, or any other legally protected factors.

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