Summary:
This growing Biotech is looking for a strong drug product development scientist to join their CMC team. This role involves formulation development, analytical testing, drug product manufacturing, and support for pre-clinical and clinical studies. The ideal candidate should be highly motivated, able to multitask, and thrive in a dynamic environment.
Responsibilities:
- Lead formulation development and drug product manufacturing activities.
- Act as an SME in developing stable formulations for clinical-stage biotherapeutics.
- Design and evaluate formulations through stability studies.
- Perform analytical testing to assess product stability.
- Oversee DP container selection and Fill/Finish processes with CDMOs.
- Ensure GMP compliance during manufacturing.
- Lead compatibility studies of clinical administration components.
- Collaborate with internal teams and external partners.
- Contribute to regulatory filings and technical reports.
- Manage day-to-day lab activities and maintain equipment.
- Engage in scientific discussions and present findings.
Qualifications:
- MS/PhD in Biochemistry, Biophysics, Chemical Engineering, or related field.
- Minimum of 8 years of biotech industry experience in formulation development and GMP DP Fill/Finish manufacturing.
- Expertise in formulation development methodologies and analytical techniques for mAbs, ADC's, Bispecifics, or fusion proteins is highly desired.
- Strong understanding of cGMP regulations.
- Excellent communication and multitasking skills.
