Formulation Scientist I

DescriptionPurpose and Scope Person is responsible for the development of specialty injectable pharmaceutical formulations by working independently and in a mentor role providing guidance for department timelines and scientific objectives. Essential Duties & Responsibilities Develop injectable pharmaceutical formulations having some emphasis on complex product development and emerging technologies. Develop injectable pharmaceutical formulations utilizing Quality by Design (QbD) and risk assessment concepts. Contribute to the establishment of patent design around strategies for PIV submissions and submission of patent applications for proprietary products. Coach Formulation Associates in formulation development. Contribute and guide analytical efforts and interpretation of data generated from experimental batches. Provide technical expertise to process development and manufacturing when required. Write/review technical documents to support regulatory submissions and technical transfers. Interact cross departmentally and provide technical guidance to achieve company objectives. 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 Proficient formulation development skills covering specialty formulations including some exposure to other emerging technologies e.g. lyophilization, polymer-based delivery, liposomes, microspheres etc., and preferably with proteins and peptides. Proven contributor when working on complex problems within formulation development and process tech transfers in which analysis of situations or data requires an in-depth evaluation of various factors. Hands on experience and proficiency in various analytical techniques including HPLC, LC-MS, CD, SEM/TEM, FTIR, DSC and DLS. Experience in the interpretation of patents and prosecutions histories as well as contributing to patent applications. Experience in drafting technical documents to support FDA filings. Supervisory experience preferred with good interpersonal and organizational skills. Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought. Reputation as a solid contributor and mentor 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. Core Values This position is expected to operate within the framework of Tolmar's Core Values: Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together. Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes. Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality. Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future. Education & Experience Bachelor of Science, in Chemistry, Biochemistry or Pharmaceutical Sciences required. Masters or Ph.D. preferred. Pharmaceutical formulation development experience combined with BS: 5+ years; Masters: 2+ years or Ph.D.: 1-2 years. Working Conditions Laboratory, pilot scale, and manufacturing settings. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals. Some travel required. Compensation and Benefits Annual Pay Range: $105,000 to $115,000 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 candidates 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.QualificationsEducationBachelors of Science (required)Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.