Purpose and Scope

The scientist in the Scientific Leadership Development Program will have 6-month rotations for 2 years and work with multiple departments to develop pharmaceutical products and learn about the entire pharmaceutical process, from ideation to regulatory submission and commercial manufacturing. After completing the program, the scientist will be placed into a team appropriate to the skill sets developed. The scientist in the Scientific Leadership Development Program fosters an environment of technical leadership, safety and company culture.

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.

Core Values

• The Research Associate III, Scientific Leadership Development Program is expected to operate within the framework of Tolmar’s Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients and take action with great speed and efficiency no matter the task.

Education & Experience

• Ph.D. or PharmD in a scientific field or a Master’s degree in chemical engineering.

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

• Annual Pay Range: $70,000 - $78,000
• 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.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis 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. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Education

• Masters or better in Chemical Engineering
• PHD or better in Science or related field

Behaviors

• Leader: Inspires teammates to follow them

Motivations

• Ability to Make an Impact: Inspired to perform well by the ability to contribute to the success of a project or the organization
• Growth Opportunities: Inspired to perform well by the chance to take on more responsibility

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)