In this role you will lead GMP Manufacturing, Supply Chain, and Manufacturing Science and Technology (MS&T). It ensures reliable clinical and commercial supply through scalable manufacturing, resilient supply chains, and science-based process optimization. The VP sits on the Technical Operations leadership team. The VP partners with Quality, Regulatory Affairs, Clinical Operations, Facilities, Engineering, Finance, Research, and external partners.
This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.
DUTIES AND RESPONSIBILITIES: - Strategy and Organization: Set manufacturing strategy, build and scale the organization, and plan capacity and workforce.
- Compliance and Quality: Ensure cGMP and regulatory compliance and keep the site inspection-ready with Quality.
- Process and Technology: Drive process performance, technology transfer, MS&T lifecycle activities, and automation, digitalization, and manufacturing execution systems (MES).
- Supply chain and Partners: Oversee supply planning, sourcing, and Sales and Operations Planning (S&OP). Manage CDMOs and critical suppliers.
- Regulatory and Facilities: Support regulatory filings (INDs and BLAs) and partner on facility expansion and qualification.
- Finance and Reporting: Manage budgets and capital plans, set KPIs, and report risks and recommendations to executives and the Board.
- Culture and Representation: Foster a culture of safety, compliance, and continuous improvement, and represent the company in external forums.
EDUCATION AND EXPERIENCE: - A bachelor's degree in engineering or life sciences is required. An advanced degree (MS, PhD, or MBA) is preferred.
- At least 15 years in biopharma or cell and gene therapy manufacturing, including 8 or more years in senior leadership.
Required: - GMP manufacturing leadership
- Process development and scale-up
- MS&T and technology transfer
- Supply chain and CDMO management
- Regulatory inspection experience with the FDA, EMA, and others
- Leading large teams and delivering on budget and schedule
Preferred: - Experience with automation, MES, and digital manufacturing. Prior autologous cell therapy manufacturing experience is strongly preferred.
JOB SPECIFICATIONS: - Executive and People leadership
- Enterprise Judgement and Risk Management
- Financial Acumen
- Executive Communication.
WORKING CONDITIONS:General office, manufacturing, laboratory, and cleanroom environment. This position requires occasional presence in GMP manufacturing areas and interaction with production operations. The employee may be exposed to standard laboratory materials and manufacturing equipment. Domestic and international travel may be required. Some Cleanroom access is required
PHYSICAL DEMANDS:While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.
Total Rewards and Culture:Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.
The anticipated salary range for candidates who will work in San Diego is $308,700-$377,300 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.
