Senior Director, Technical Sciences
Semma Therapeutics
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See open jobs at Semma Therapeutics.See open jobs similar to "Senior Director, Technical Sciences" F-Prime Capital Partners.Job Description
The Senior Director, Technical Sciences (MSAT) provides a critical leadership role for Process Development, Cell and Genetic Therapies, reporting to the Vice President, Process Development. The role is responsible for technical leadership for clinical product support activities related to technology transfers, manufacturing technical support and investigations, manufacturing data trending, regulatory activities and process change management.
Key Responsibilities:
- Primary responsibilities extend to technology transfer, manufacturing support, process validation, and process monitoring for products in clinical development.
- Lead the development and execution of technology transfer plans for internal and external manufacturing sites
- Lead the troubleshooting of drug substance and drug product products and processes.
- Deliver drug substance/product stewardship through continuous process verification.
- Foster and drive collaboration between Technical Sciences/PD and other Vertex functions including Clinical Manufacturing, Commercial Manufacturing and Supply Chain, Quality and Regulatory functions.
- Ensure effective partnerships with CDMOs and key suppliers to meet manufacturing, program, and strategic goals.
- Identify and/or lead compliance and efficiency related projects working towards the goal of continuous improvement to increase value and efficiency.
- Provide guidance and applicable content for CMC regulatory submissions and ensure technical compliance with established conditions.
- Participate in technical interactions with regulators for regulatory submissions and health authority inspections.
- Develop a high performing team with focus on colleague development and performance while creating a collaborative environment that attracts, develops, and retains personnel.
- Be a champion for change management for building MSAT capabilities including business processes, laboratory capabilities and operating model.
Minimal Requirements:
- Bachelor's Degree in life sciences, bio-engineering or related discipline is required.
- Typically requires 12 years of experience in pharmaceutical/biopharmaceutical industry with 8 years of increasing management responsibility, or the equivalent combination of education and experience
- Experience with technical support of clinical / commercial biological products and cGMP manufacturing. Experience with cell and gene therapies a significant plus.
- Extensive knowledge of US and EU cGMP regulations/guidance; experience with regulatory agency inspections is highly desirable
- Experience with technology transfer, process validation and process monitoring.
- Direct experience working with contract manufacturing (CDMO) and/or technical service partners.
- Technical experience supporting manufacturing quality compliance including deviations, change controls and CAPAs.
- Experience with developing CMC content and knowledgeable on regulatory guidance and trends.
- Proven experience with leading a high-performance team and/or complex cross-functional projects.
- Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and efficiency.
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
This job is no longer accepting applications
See open jobs at Semma Therapeutics.See open jobs similar to "Senior Director, Technical Sciences" F-Prime Capital Partners.