Associate Principal Scientist - Bioanalysis

General

• Support and participate in company initiatives.
• Interact with clients, other employees, and the community in a professional manner.
• Perform other duties as assigned.

Specific

• Contribute to existing SOPs and develop new SOPs as needed.
• Establish the experimental design and manage the conduct of studies in compliance with the protocol/amendments/planned changes, Best Practice Documents and SOPs.
• Perform all other duties and responsibilities of a Principal Investigator as defined in applicable SOPs
• Operate analytical instrumentation and lab equipment and perform analyses according to the Operation Manuals, SOPs, and/or Best Practices.
• Demonstrate an understanding of Best Practices, SOPs and Good Laboratory Practice Regulations (21 CFR, Part 58) as these relate to study-specific services provided, this job description, and general facility operations
• Serve as the Company representative and point of contact to Study Directors and/or Sponsors for bioanalytical projects. This includes establishment of a correspondence file for documenting Study Director/client exchanges including phone conversations, emails, faxes, and mail.
• Provide a central internal and external scientific contact for studies within the Bioanalytical group. Represent the company by providing support for scientific posters or presentations at scientific meetings and/or client visits.
• Perform method development, method qualification, and/or other study-related activities.
• Determine and allocate resource needs for study execution.
• Review literature to determine the most appropriate approach for project-specific bioanalytical needs.
• Assure that the Lab Manager and/or Study Director is aware of any deviations from the study protocol and/or SOPs during a study and ensure that proper documentation is performed.
• Lead, train, and mentor colleagues to enhance analytical skills and DMPK knowledge.
• Lead efforts to troubleshoot and solve method development or assay challenges.
• Review and approve raw data and reports to be sent to internal and external clients.
• Assure that study data and samples are compiled, organized, inventoried, and archived at Company or transferred to the testing facility archive/client prior to or upon completion of the services, as applicable

• BS or equivalent degree in Chemistry, Biochemistry, or related field, and greater than 15 years of Analytical and/or Bioanalytical Chemistry laboratory experience including study management or
• MS in Chemistry, Biochemistry, or related field, and 7 to 10 years of Analytical and/or Bioanalytical Chemistry laboratory experience including study management or,
• Ph.D. in Chemistry, Biochemistry, or related field and 3 to 5 years of Analytical and/or Bioanalytical Chemistry laboratory experience including study management
• Demonstrated experience with the Sciex Mass Spec Platform

Skills and abilities

• Working knowledge and awareness of general laboratory procedures.
• Displays versatility and accuracy performing laboratory operations, some of which may be difficult and/or non-routine.
• Ability to use a computer to compile and maintain databases for records and inventory, utilizing the appropriate software.
• Ability to adhere to all safety regulations and procedures.
• In-depth knowledge and specific understanding of analytical testing needed in drug discovery as it relates to DMPK.
• Understanding of GMP/GLP/GCP regulations with the ability to apply these practices daily.
• An attitude for quality, an eye for detail, the ability to follow written instructions and work with a minimum of supervision.

Employees are offered a fun, fast-paced work environment with competitive pay, benefits package including medical, dental, and vision insurance, 401k with company match, stock options, and much more!

We are looking for an accomplished scientist to join our growing drug discovery DMPK and Small Molecule Bioanalysis team. Our site has grown to 120 employees and our team has grown to 8 scientists. We have developed a collaborative culture and mutual respect. Related to our growth we have recently purchased our third Sciex Mass Spec in the last 90 days in addition to our existing platforms. Our site is part of an 1800 person growing publicly traded international organization with over 15 sites. We recently made a $4.5MM investment to our site.

There is a strong training platform in place and we can consider candidates from existing preclinical CRO, Urine Toxicology labs, Agrochemical labs, or Environmental labs. If you would like to further your career in drug discovery or are looking to make the jump over from a related industry, this is the opportunity.