Formulation Scientist II
Fort Collins, CO 80521
Purpose and Scope
Person exhibits leadership capabilities in the development of injectable pharmaceutical formulations providing mentorship as well as setting timelines and scientific objectives for the department.
Essential Duties & Responsibilities
- Develop broad range of injectable pharmaceutical formulations with an emphasis on complex product development and new delivery technologies
- Develop injectable pharmaceutical formulations utilizing Quality by Design (QbD) and risk assessment concepts.
- Interact with patent attorneys to establish patent design around strategies for PIV submissions and submission of patent applications for proprietary products.
- Lead Formulation Associates regarding development of all types of injectable formulations.
- Contribute and guide the analytical efforts and interpretation of data generated from experimental batches.
- Write/review technical documents to support regulatory submissions and technical transfers.
- Interact cross departmentally and provide technical guidance to achieve company objectives.
- Understand and provide a global perspective of the development process.
- Contribute to activities covering all aspects regarding intellectual property. Participate in required annual hazardous waste training.
- Participate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
- Perform various other duties as assigned.
Knowledge, Skills & Abilities
- Mastery of formulation development skills covering specialty formulations including some exposure to other emerging technologies e.g. polymer based delivery, microspheres, lyophilization, etc., and preferably with proteins and peptides.
- Demonstrated leadership when working on complex problems within injectable formulation development and process tech transfers in which analysis of situations or data requires an in-depth evaluation of various factors
- Knowledgeable in the interpretation of patents and prosecutions histories as well as contributing to patent applications.
- Experience and proficiency in various analytical techniques including HPLC, LC-MS, CD, SEM/TEM, FTIR, DSC and DLS.
- Supervisory experience with exceptional interpersonal and organizational skills that directly relate to the advancement of others and of the department as a whole.
- Continued demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
- Reputation as an emerging leader in the field with sustained performance and accomplishment.
- Excellent oral and written communication skills demonstrated through interactions internally and externally with marketing partners, vendors, and legal counsel.
- The Formulation Scientist II 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
- Bachelor of Science in Chemistry, Biochemistry or Pharmaceutical Sciences required. Masters or Ph.D. preferred.
- Injectable formulation development/supervisory experience combined with BS: 8+ years; Masters: 5+ years or PhD: 2+ years.
- Laboratory setting, pilot scale, and manufacturing settings. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
Compensation and Benefits
- Annual Pay Range: $108,000 - $120,000
- Bonus eligible
- Benefits information: https://www.tolmar.com/careers/employee-benefits