Full Time
Madison
Posted 1 month ago

JOB OBJECTIVE: This role will focus on rigorous characterization and method development/validation activities for known and novel psychedelic compounds targeted for potential clinical use. The primary focus will be on developing analytical GLP/GMP policies and practices, supporting testing for drug substance process development, characterization of compounds and impurities, and other activities associated with production of high quality research-grade and cGMP materials. This position will require effective written and oral communication across R&D, pre-clinical, clinical, and regulatory stakeholder channels, and requires maintaining the highest professional standards consistent with a Schedule I DEA license and regular DEA audits.

CORE DUTIES:

1. Serve as Analytical Lead for on-going or new projects and take ownership of analytical requirements needed, including scheduling, prioritizing and coordinating analytical testing.

2. Support method development and validation activities for new drug substances and drug products.

3. Independently design and initiate development of analytical methods and improve upon existing methods to support all stages of API and drug product development.

4. Proficiency with various related analytical techniques, such as UHPLC, GC, FTIR, HRMS, KF, XRPD, etc.

5. Perform instrument validation and qualification, calibration, maintenance, and troubleshooting on analytical equipment.

6. Prepare technical reports, presentations, SOPs, and policies and procedures.

7. Embrace cGMP requirements for all work associated.

8. Maintain accurate research and analytical documentation consistent with GLP/GMP standards.

9. Identify capital equipment and requirements for the AD laboratory.

10. Maintain security and documentation consistent with DEA and organizational requirements.

11. Coordinate movement of controlled substances from manufacturing through analytical testing in compliance with DEA CFR.

12. May conduct educational seminars to advance technical and theoretical competence.

13. Conduct appropriate interpretive literature reviews. Present oral and written interpretations to the Institute’s scientific advisory board and outside collaborators in order to prioritize future projects.

14. Maintain high level of knowledge related to current developments in relevant scientific fields.

15. Assist with additional projects as required per workflow.

16. Understand and comply with ethical, legal, and regulatory requirements applicable to our organization.

17. Safety of self and others is of the utmost importance. All duties must be performed in a safe manner including a thoroughly researching and understanding safety concerns. Potential exposure must be thoroughly mitigated through appropriate use of PPE and environmental contamination controls. All employees are required to attend regularly scheduled safety meetings. Responsible for monitoring safety practices of assigned area.


KEY QUALIFICATIONS:

1. Ph.D. or M.S. in Chemistry (or related field) with 3+ years of relevant experience, or B.S in Chemistry (or related field) with 5+ years of relevant experience.

2. Mastery of analytical techniques and data analysis specific to CMC regulatory requirements for pharmaceutical products.

3. Strong skills in and appreciation for emotionally intelligent social interaction and communications.

4. Demonstrated success in technical proficiency, productivity, publication, scientific creativity, collaboration, and independent thought.

5. Thorough knowledge of scientific principles and concepts.

6. Ability to work independently and in a large team of chemists, biologists, and clinicians.

PHYSICAL DEMANDS:

1. Ability to use computer and laboratory equipment needed to carry out the duties described above.

2. Occasional travel may be required.

Diversity is important at Usona. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

Job Features

Job Category

Business Development, Scientific

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