Senior Pharmaceutical Development Scientist

Our client, a leading pharmaceutical company, is seeking an experienced Senior Pharmaceutical Development Scientist to join their Research & Development team in Denver, Colorado . This pivotal role will focus on the formulation development and process optimization of novel drug candidates, from pre-clinical stages through to clinical trials and commercialization. You will be responsible for designing and executing experiments, analyzing data, and contributing to the overall strategy for drug product development. The ideal candidate possesses a strong background in pharmaceutics, extensive hands-on experience with formulation techniques, and a deep understanding of regulatory requirements for drug development. This is an excellent opportunity to contribute to bringing life-changing therapies to patients worldwide.

Key Responsibilities:

Design and conduct formulation development studies for various dosage forms (e.g., oral solids, injectables, topical). Develop and optimize manufacturing processes for drug products. Characterize the physical and chemical properties of drug substances and drug products. Perform stability studies to assess product shelf-life. Develop analytical methods for characterizing and testing drug products. Troubleshoot formulation and manufacturing process issues. Prepare technical reports, development summaries, and regulatory submission documents. Collaborate with cross-functional teams, including analytical development, CMC regulatory affairs, and clinical operations. Stay current with scientific literature, industry trends, and regulatory guidelines in pharmaceutical development. Manage external contract research organizations (CROs) for specific development activities. Mentor junior scientists and provide technical guidance.

Qualifications:

Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, Chemical Engineering, or a related field. 6+ years of relevant experience in pharmaceutical formulation development. Proven experience in developing and optimizing solid dosage forms (tablets, capsules) and/or parenteral drug products. Hands-on experience with formulation techniques, including granulation, encapsulation, lyophilization, and sterile manufacturing. Strong understanding of drug delivery systems and advanced formulation technologies. Proficiency with analytical techniques such as HPLC, dissolution testing, and DSC. Knowledge of cGMP regulations and guidelines for pharmaceutical development and manufacturing. Excellent problem-solving skills and attention to detail. Strong written and verbal communication skills. Ability to work independently and manage multiple projects simultaneously. Experience with new chemical entities (NCEs) is highly desirable.