An innovative, multi-million dollar bio-pharmaceutical company is currently seeking a driven, experienced CMC Formulation/Drug Product Leader to join their team of formulation scientists. You will play a key role in the organizations drug product development pipeline, ranging from pre-formulation to formulation and commercialization.
Duties and Responsibilities:
- Ensure protocols follow the company policies, cGMP, USP and FDA regulations
- Strong communication, organization, and multitasking skills are needed to lead internal and external drug product CMC activities
- Experience in drug product technology transfer, formulation and process characterization, and stability testing
- Establish a Formulation strategy and development plan while collaborating cross functionally with Clinical, Regulatory, Process Chemistry, Analytical, DMPK, and Technical Operations
- Focus on multiple programs within their pipeline
The candidate should have:
- Strong hands-on experience in small molecule formulations
- Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
- Past experience overseeing outsourced vendors (CMOs/CTLs/CDMOs) - highly coveted
- S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 3-7 years of industry
- Experience authoring CMC sections for IND, IMPD and NDA is highly sought after
If you are interested in opportunity, then please don't wait to apply.