Work in an FDA-regulated environment and adhere to Standard Operating Procedures (SOPs)
Perform both routine analyses and development using analytical instrumentation such as high-performance liquid chromatography (HPLC) and gas chromatography (GC)
Perform in vitro release method development
Present analyses and recommendations in product development team meetings
Collaborate with team members from multiple departments within the company and with external clients to achieve project and company goals
Oakwood Laboratories is a privately owned specialty pharmaceutical company focused on the design, development, and commercial manufacture of sterile injectable sustained release pharmaceuticals. This unique class of products delivers therapeutic levels of drug to patients over days, weeks, months or even years with a single intramuscular or subcutaneous injection. Products of this class have extremely high commercial potential.
Desired skills and experience include:
Bachelor’s in chemistry + 5 years of related experience, M.S. in chemistry + 3 years of related experience, or PhD in chemistry
Demonstrated experience in analytical method development for pharmaceutical products, method validation, and understanding of the pharmaceutical product development process
Demonstrated success working with regulatory and cGMP requirements
Good written and oral communication skills
Time management skills, attention to detail, and ability to work efficiently to meet company deadlines
Oakwood Labs offers a one-stop shop to support all phases of long acting injectable (LAI) development. As a leading manufacturer of sustained release pharmaceuticals, we will work with you through proof of concept, feasibility studies, clinical trial material, and ultimately FDA-approved commercial supply.
Oakwood Labs has over 20 years of drug encapsulation experience using Chroniject™, our patented microsphere-based technology. Chroniject™ provides the ability to control particle size, customize release durations from weeks to years, and minimize residual solvents to achieve critical quality attributes.