Associate Director/Project Manager, Drug Substance CMC Supply Chain

JOB DESCRIPTION: 

Commercial Manufacturing and Supply Chain (CMSC) Associate Director project Manager, POVE

POSITION 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 technical background, solid working knowledge of GMPs, experience interacting with external manufacturers/service providers, understanding of the drug development pathway through 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.

RESPONSIBILITIES:

·        Partner closely with POVE program management lead, Drug substance functional area lead and Manufacturing CDMO to develop, maintain and actively monitor manufacturing, validation and testing project plans. Identify/communicate interdependencies as well as critical path activities for the project(s).

• Track and monitor key milestones and decision points and work with project team members to drive delivery of project objectives.
• Effectively communicate with internal and external team members, and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects
• Organize and maintain team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses/mitigation strategies using Program Management preferred technologies
• Update and maintain project status tools, such as a project action log, risk register, budget and reporting dashboards
• Assist in the creation and deployment of templates to manage team activities

·        Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable

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 and managing external CDMOs 

·        A minimum of 5 years of experience in project management of biopharmaceutical products

·        Experience interacting with and/or managing CMOs/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, Primavera, OnePager, Kidasa, 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.