Job Description

Job Description

Job Description

Job Description

Position Title

Senior Scientist/ Principal Investigator - Bioanalysis DMPK Biotransformation

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. Our site is part of a 2400 person growing publicly traded international organization with over 15 sites. We recently made a $4.5MM investment in our site.

The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology, and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings.

Position Requirements

Education and experience

• 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

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.
• Strong Knowledge of LC-MS/MS instrumentation, troubleshooting, method development, and analysis of biological fluids and tissues, preferably on a Sciex Platform for qualitative and quantitative analysis

Responsibilities and Duties

• Lead, train, and mentor colleagues to enhance analytical skills and DMPK knowledge.
• Lead efforts to troubleshoot and solve method development or assay challenges.
• 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.
• Contribute to existing SOPs and develop new SOPs as needed.
• 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 the 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.
• 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

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!

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