Senior Scientist en Piramal Pharma Solutions
Piramal Pharma Solutions · Lexington, Estados Unidos De América · Onsite
- Senior
- Oficina en Lexington
Business: Pharma Solutions
Department: Formulation R&D (FRD)
Location: Lexington, KY
The Senior Formulation Scientist is responsible for formulation development of sterile injectable dosage forms, from pre-clinical development through product commercialization.
• Design studies related to pre-formulation and formulation of parenteral products, including solubility, pH solution stability, lyophilization, suspension development, polymer development and others that may impact the stability and delivery of the product.
• Experimental design, data evaluation, generation of scientific reports, and coordination studies with other technical groups
• Plays an important role in the scale-up and technology transfer process in collaboration with Manufacturing team
• Investigates, troubleshoots and resolves issues associated with formulation studies and/or R&D pilot manufacturing
• Responsible, in collaboration with management, to develop and track project timelines and assumes departmental responsibilities for projects when necessary.
• Consults and interacts with internal cross-functional teams and external clients and customers
• Operate equipment and apply analytical methodology utilized in the formulation development of parenteral dosage forms (e.g. lyophilizers, compounding/filling equipment, mixing techniques, sterilization techniques, HPLC, KF, particulate matter, etc.)
• Apply and provide feasibility assessment for a variety of scientific principles and concepts to potential clients, products and investigations.
• Conducts literature searches to support formulation development and/or pilot manufacturing documentation
• Effectively communicates and defends own work, orally and in writing, at team meetings, in technical documents, and to external partners
• Assist, consult, and trouble-shoot during process transfer scale-up and validation activities
• Interpretation of results and scientific information including proficiency in statistical evaluation of data and design of experiments.
• Interact with cross functional departments including Business Development, Project Management, ARD, QC, Process Development, Quality, Operations and with external clients
• Conduct administrative functions as required or assigned
• 10+ years’ working within pharmaceutical industry, focusing on developing parenteral, solid and/or other formulation applications within a Clinical/Commercial manufacturing organization
• Experience on a wide variety of dosage forms (i.e. parenterals, lyophiles, polymers, suspensions, drug delivery systems, etc.) design of experiments, statistics, and unique technologies
• Experience in lyophilization cycle development and suspension development
• Thorough knowledge of relevant analytical techniques required for formulation and product analysis
• Demonstrated ability to provide technical procedure/direction and interact professionally and effectively with management, peers, team members, supervisors, and outside customers on an ongoing basis to ensure product development success.
• Experience serving on interdisciplinary and multidisciplinary teams
• Strong technical aptitude; excellent organizational, technical, and creative problem solving skills.
• Flexible and adaptable to changing priorities; comfortable working in a matrix environment, while embracing change.
