Senior Scientist, Formulation Development

Job Description

Position Overview:

Enteris BioPharma is a clinical-stage biopharmaceutical company offering innovative formulation solutions and products built around its proprietary drug delivery technologies. 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. You will be a highly motivated self-starter with experience in formulation and process development, from benchtop to scaleup and clinical trial material manufacturing. You will be part of a team leveraging existing formulation technology to deliver drug products to patients, while also exploring innovative approaches to drug delivery.

The Role:

  • Conduct formulation and process development for internal and client-sponsored programs. Scale processes from benchtop to GMP manufacturing equipment for clinical trial material production.
  • Contribute to the development of innovative drug delivery technology and patents.
  • 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.
  • Work with Analytical Development, Manufacturing, QC, QA and other groups to ensure project requirements are met.
  • Resolve technical issues, and make recommendations for various options that would solve the issue, including the preferred option.
  • Work independently but collaboratively. Recognize key issues likely to affect successful and/or timely completion of work and bring them to the attention of the supervisor.
  • Write technical reports.
  • Execute technical activities involving active pharmaceutical ingredients that may be potent or hazardous while following appropriate safety procedures.

The Candidate:

  • A highly motivated self-starter willing to try new and creative approaches to formulation development and drug delivery.
  • MS with about 5-7+ years of relevant experience in formulation and process development, 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 spray drying is preferred.
  • 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.
  • Good writing skills and experience preparing technical documents and reports.
  • 505(b)2 development skills are desirable.

Position Benefits:

  • Medical, Dental, Vision and 401K with matching contributions
  • Sick leave (5 days), paid time off (commensurate with experience) and paid holidays (6 days plus winter break from Christmas through New Year’s Day)
  • Annual bonus (based on performance)

Interested and well-qualified candidates may send their resumes to careers@enterisbiopharma.com.