Purpose and ScopeThe Scientific Leadership Development Program provides four six-month rotations over two years, offering cross-functional experience across the pharmaceutical product lifecycle, from ideation and development through regulatory submission and commercial manufacturing. Upon successful completion of the program, participants will transition to a team aligned with their demonstrated skills, experience, and organizational needs. Throughout the program, it is expected to model technical leadership, promote a strong safety culture, and uphold Tolmar's values.
Essential Duties & Responsibilities (these will change slightly during rotations)
- 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
- Perform other related duties as assigned.
Knowledge, Skills & Abilities- Gain proficiency in the operation of analytical laboratory instruments such as HPLC, GC, FTIR, pH, 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
- Drug-device combination product development
- Basic knowledge of:
- Process scale-up concepts
- 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 (e.g., weighing, volumetric glassware)
- Experience in equipment troubleshooting, maintenance, and repairs.
- Effective written presentation and oral communication skills.
- Experience with word processing, spreadsheet, and database programs (e.g., MS Office, Smartsheet).
- 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.
Education & Experience- Ph.D., or Pharm D in a scientific Field or a Master's degree in chemical engineering.
- Must be a recent graduate who completed the required degree within the past year.
Working Conditions- Work is performed in typical office and laboratory settings and may involve exposure to pharmaceutical substances, solvents, biological materials, and pharmaceutical waste.
- Core Hours: Monday-Friday, 8am-5pm
- Location: On Site in Fort Collins, Colorado, USA
Compensation and Benefits- Annual Pay Range: $90,000 - $94,000
- Benefits information: https://www.tolmar.com/careers/employee-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.
