Vice President of Process Development
- Location: Princeton, NJ
- Working Situation: Remote
- Level: Vice President
A rapidly expanding biotech is working to produce innovative drug therapies within biologics projects in the pipeline ranging from Phase 1 to Commercialization. This role will oversee the development, maintenance, and implementation of process methods. The position will work directly with the Senior Vice President to address the evaluation of process development practices and procedures in order to ensure proper compliance with legal, regulatory, and manufacturing procedures.
The Vice President of Process Development role will focus on management of the Process Development department, while also being responsible for input regarding hiring, retention, and performance management of all Process Development employees.
The Vice President of Process Development will:
- Ensure compliance with regulatory requirements within the development process as a way of mitigating risks to the organization.
- Develop, implement, and maintain process methods and equipment to assure the effective process of formulas, products, and technology.
- Provide leadership to members of the Process Development team in the form of mentorship and sharing of knowledge and skills.
- Review status reports from project personal in order to modify schedules as needed. This includes preparing project reports for management teams, clients, and others in order to ensure on time delivery.
- Work with key stakeholders in research, clinical development, regulatory affairs, quality, and commercial organizations
The Vice President of Process Development has the following qualifications:
- 15+ years of relevant experience and PhD OR 20+ years of relevant experience and master's degree OR 25+ years of relevant experience and bachelor's degree
- Proven to be able to lead process scientist's functionality, while providing coordination with manufacturing, QA/QC, and development of the organization as a whole
- Strong knowledge of the CMC pipeline and current industry practices
Company Benefits:
- Competitive 401k program, health insurance, and paid family and medical leave, and family support
- Annual bonus based on performance targets met
- Competitive LTIs program in the form of stock
- 7% 401k match available
- Bi-weekly company lunches
