Scientific Leadership Development Program Manager

1 day ago

Fort Collins, Colorado, United States TOLMAR Full time
Job Summary

The Scientific Leadership Development Program at Tolmar is a 2-year rotational program designed to develop the next generation of scientific leaders in the pharmaceutical industry. As a participant in this program, you will have the opportunity to work with multiple departments, develop pharmaceutical products, and learn about the entire pharmaceutical process, from ideation to regulatory submission and commercial manufacturing.

Key Responsibilities
  • Develop pharmaceutical formulations utilizing Quality by Design and risk assessment concepts.
  • Apply regulations for drugs and medical devices, including USP, ICH, and FDA regulations.
  • Adhere to validated test methods, standard operating procedures, and applicable industry guidance.
  • Maintain and review laboratory notebooks according to in-house standard operating procedures.
  • Efficiently write and review technical reports, summaries, protocols, test methods, standard operating procedures, and other documents.
  • Use technical discretion in the design, execution, and interpretation of experiments.
  • Participate and comply with required Tolmar training.
  • Interact closely with project teams across departments and outside testing laboratories.
  • Interpret, review, and discuss data from outside testing laboratories.
  • Assist junior team members by mentoring, training, and coaching others.
  • Apply basic statistics for data trending and design of experiments.
Requirements
  • Ph.D. or PharmD in a scientific field preferred or a Master's degree in chemical engineering.
  • Gain proficiency in the operation of analytical laboratory instruments such as HPLC, GC, FTIR, pH, and GC.
  • Gain proficiency with FDA regulations, USP, NF, ICH, EP, and their application in the laboratory.
  • Proficient in effectively writing and accurately reviewing technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or for submission to government agencies.
  • Demonstrate understanding of drug product formulation development.
  • Basic understanding of common critical quality attributes (CQAs) of drug products based on formulation and stability.
  • Introductory knowledge of intellectual property, regulatory requirements, and drug-device combination product development.
  • Basic knowledge of process scale-up concepts and formulation development concepts for specific types of pharmaceutical formulations.
  • Demonstrated proficiency regarding GDP, GLP, and cGMPs, data interpretation and statistical analysis, safe laboratory practices, chemical handling, and equipment operation.
  • Ability to work well independently and within a team environment.
  • Experience with laboratory and wet chemistry techniques, equipment troubleshooting, maintenance, and repairs.
  • Effective written presentation and oral communication skills.
  • Experience with word processing, spreadsheet, and database programs.
  • Experience with computer systems for laboratory instrumentation and raw data handling.
  • Learn and apply new technologies to problem-solving.
  • Attention to detail, be efficient, accurate, and consistent in data compilation and review.
  • Work independently and with other scientists to concurrently handle multiple projects and timelines.
  • Demonstrate problem-solving in a timely manner.
Working Conditions
  • Laboratory setting. Will work with pharmaceutical substances, solvents, biological materials, pharmaceutical waste.
  • Core Hours: Monday-Friday, 8am-5pm.
  • Location: On Site in Fort Collins, Colorado, USA.
Compensation and Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidate's qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation, or any other applicable status protected by state or local law.

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