Enteris BioPharma is a clinical stage biopharmaceutical company offering innovative formulation solutions built around its proprietary oral drug delivery technologies. The technology has been developed and proven effective to enable the delivery of BSC III and IV compounds including peptides, peptidomimetics, and small molecules with low oral bioavailability. In addition to its formulation development expertise, Enteris has a 32,000 square-foot GMP facility offering a range of manufacturing and analytical services.
We are looking for a Senior Scientist to join our Formulation Development team. This person will be a highly motivated self-starter with broad experience in solid oral dosage form (immediate- and modified-release tablets and capsules) formulation and process development, from benchtop to scaleup and clinical trial material manufacturing.
- Conduct formulation and process development of tablets and capsules for internal and client-sponsored programs. Scale processes from benchtop to GMP manufacturing equipment for clinical trial material production.
- Apply knowledge of preformulation studies and physicochemical data needed to support formulation development.
- Work with members of Formulation Development and Manufacturing to prepare technical and clinical batches of products. Activities may include: conduct formulation development and process optimization studies, prepare batch records, conduct batch manufacturing and complete batch documentation as required.
- Works with Analytical Development, Manufacturing, QC, QA and other groups to ensure project requirements are met.
- Resolves technical issues, makes recommendations for various options that would solve the issue, including the preferred option.
- Works independently but collaboratively. Recognizes key issues likely to affect successful and/or timely completion of work and brings them to the attention of the supervisor.
- Executes technical activities involving active pharmaceutical ingredients that may be potent or hazardous while following appropriate safety procedures.
- A highly motivated self-starter willing to try new and creative approaches.
- MS with about 5-7+ years of relevant experience in the formulation and process development of solid dosage forms, with a background in Formulation or Drug Delivery
- Experienced in typical tablet manufacturing processes: blending, wet and dry granulation, compression, in-process controls, and film coating.
- Prior experience with permeation enhancers or solubilization approaches is a plus
- Individual must have working knowledge of pharmaceutical raw materials such as functional and non-functional excipients used in the formulation of oral solids and other dosage forms
- Individual must have experience in general computer programs such as Word, Excel, PowerPoint
- 505(b)2 development skills are desirable
- Medical, Dental, Vision and 401K with matching contributions
- Sick leave, paid time off and paid holidays
Interested and well-qualified candidates may send their resumes to email@example.com.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.
NOTE: We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position