Director/Sr. Director, Product Development
BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Director/Senior Director of Product Development to work for a leading Bay Area biotechnology company.
Director/Senior Director, Product Development
This position is for an independent contributor who is able to tackle the challenges of developing and manufacturing combination (biologics/biomaterials) products.
- Develop and implement Product Development Strategy and Plans for device and manufacturing process activities.
- Implement effective design control and product development processes
- Identify, develop and characterize process improvements, scale-up, validation and launch activities
- Develop budgets for Process Development & Engineering for approval by executive management.
- Support operational budgets, cost controls and resource planning to meet corporate strategic objectives.
- Write, review and approve CMC portions of study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines. Prepare technical reports in support of planned regulatory submissions.
- Manage and lead the Product Development department personnel to ensure that projects are completed on time and within budget.
- Works effectively in a matrix organization with clinical, regulatory, legal, quality, marketing, manufacturing and business functions.
- Help establish short and long-term objectives in support of company strategic imperatives and goals.
- Write invention disclosures to support IP portfolio.
- MS/PhD with a background in Biomedical or Mechanical Engineering, and 10+ years of experience in the medical device, bioengineering, or biomaterials industry
- Previous leadership experience required
- Must have experience working with CMOs and experience with CMC and cGMP regulations and guidelines
- Knowledge and experience working in Process Development and Stage Gate discipline
- Design Control experience
- Proven expertise in taking medical device and manufacturing processes from concept to market
- Demonstrated strength in tact and diplomacy with internal and external collaborators and vendors
- Ability to work independently and exercise good judgment
- Effective verbal and written communication skills