Title: Executive Director - Formulation
Greater Boston Area, Massachusetts
A leading pharmaceutical company is currently seeking an experienced CMC Formulation executive to head their formulation department. This position will play a key role in the organizations drug product development pipeline, ranging from pre-formulation to formulation and commercialization.
Duties and Responsibilities:
- Interact cross-functionally with the multiple teams to advance innovative gene editing treatments through the pipeline of manufacturing
- Oversee the formulation development team and advance formulation science across various drug development stages
- Plan, coordinate, and oversee all departmental activities to guarantee the advancement of internal and external projects and their compliance with applicable cGMP and standard operating procedures
- Develop and maintain a budget, manage strategic outsourcing, implement new technology, supervise and professionally develop current staff to ensure the department operates successfully
The candidate should have:
- Strong hands-on experience in experience in oligonucleotide therapeutics and LNP delivery systems
- Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 10-15 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 hesitate to apply.