What are the responsibilities and job description for the Commercial Manufacturing and Supply Chain (CMSC) Associate Director Project Manager position at JMD Technologies Inc.?
AD, CMSC Project Management
Location: Boston, MA. 3 days onsite. (Flex for 2 but 3 is preferred)
Duration: 12 Months. Possible Extensions
MUST HAVES:
- Biologics Manufacturing
- CMC Project Management
- Need BLA submission experience
- PPQ readiness
- CMC Launch experience
Job Summary:
This Commercial Manufacturing and Supply Chain (CMSC) Associate Director Project Manager (POVE) will be responsible for supporting the cross-functional project teams executing our CMC manufacturing strategies within the POVE program. The position will work with the CMSC Program Management, CMC functional leads and interface directly with CDMOs and internal cross-functional teams. The position will track and report project scope/timeline/milestone status associated with manufacturing, process validation, release and stability testing, capacity planning, and external partner strategy. This is an exciting and visible role for a highly qualified and motivated individual.
The successful candidate will be detail-driven and have a proven track record in managing and driving CMC strategies and project success within the biotech industry. We are seeking an individual with a Biologics technical background, solid working knowledge of GMPs, experience interacting with external manufacturers/service providers, understanding of the drug substance development pathway through validations, BLA submissions and launch/commercialization, and willingness to pivot as priorities change. A strong understanding of risk management will be an asset. The successful candidate will have excellent communication skills, written and verbal, high attention to detail, and the ability to work effectively in cross-functional, matrixed teams.
QUALIFICATIONS
- Bachelor’s degree in engineering, life sciences or related field. Advanced degree (MS, PhD or MBA and/or PMP Certification preferred.
- A minimum of 8 years of experience in the biopharmaceutical industry
- Previous experience in Biologics manufacturing including process validations/PPQ and commercialization
- A minimum of 5 years of experience in project management of biopharmaceutical products
- Experience managing external CDMOs/service providers.
- Working knowledge of biotechnology, GMPs, and drug development lifecycle.
- Ability to work effectively in cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively.
- Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook). Experience with other PM tools a plus (e.g. Smartsheet, ThinkCell, OfficeTimeline Pro , OnePager, etc.).
- Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization.
- Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
- Experience with regulatory submissions, manufacturing or QC/QA experience a plus
