Vice President CMC Process Development
Location: Germantown, MD
Role and responsibilities:
Seraxis is a rapidly growing regenerative medicine company focused primarily on a replacement cell therapy for insulin-dependent diabetes. Seraxis is working to launch multiple clinical trials in 2023.
We are seeking an exceptional highly motivated Vice President of CMC and Process Development to join our dynamic team.
The position requires demonstrated ability to work in a fast-paced, hands-on, and collaborative environment. Strong commitment to quality, compliance and scientific excellence is necessary. The selected candidate will benefit from a unique opportunity to become a major contributor to the success of a well-positioned and growth-oriented cell replacement therapy company.
The job responsibilities include:
- Author and/or review process description, process control, and process development sections of regulatory filings.
- Drive the selection and management of a Contract Manufacturing and Development Organization (CDMO) in conjunction with other team members.
- Lead the technology transfer effort for manufacturing outsourcing.
- Develop and support the implementation of processes and associated SOPs for risk-based approaches for raw material risks, impurity/residual clearance, process control strategy.
- Author, review and/or approve process development/transfer/validation study protocols and reports to ensure high quality documentation to support regulatory filings.
- Proactively identify risks and issues in CMC programs, develop solutions and drive to resolution.
Qualifications and Skills:
- Ph.D. in Biochemical Engineering or related discipline with 10+ yrs. process development experience, or MS with 12+ yrs.
- Demonstrated knowledge of cGMP practices, ICH/ FDA guidance documents and quality system.
- Experience in working with external CDMOs.
- In-depth scientific knowledge and technical proficiency.
- Process development experience for Cell and Gene therapies is required.
- Strong grasp and application of engineering fundamentals pertaining to process development.
- Experience with process development, tech transfer, and process validation activities.
- Familiar with stability testing and completing CMC section of regulatory submissions desired.
- Excellent oral and written communication skills.
- Demonstrated ability to work in a cross-functional team environment and to design experiments and research strategy.
Job type: Full time
Salary range: Competitive. Stock options. 401K
Seraxis is an Equal Opportunity Employer. Please email cover letter and resume to Info@seraxis.com.