Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

How will you make an impact?

Successful lead key customer programs to facilitate the organization delivering on commitments. Requires successfully leading a cross functional team in all matters related to the development, tech transfer, characterization and commercialization of the cell and gene therapy manufacturing processes. The position requires a highly motivated and tenacious, self-starter. This role interacts significantly with the customer as the point of contact, representing both the interests of the business and the customer. The individual must have technical knowledge, as well as traditional program management and leadership skills.

• Plan and deliver all stages of program within a matrix organization on budget and time. Specifically, this includes the introduction of new products into the facilities, process development, analytical method development and qualification, preparation for non-GMP and GMP manufacturing.
• Resolve project team issues and facilitate decision making within the team. Drive progress to completion to the required standard.
• Communicate regularly with the business team, VVS Plainville technical team, and customer team. Report on the initially agreed upon customer and internal milestone sharing progress, issues, and risks.
• Demonstrate role model leadership in the execution of PM standard work and customer centric behavior.
• Track and manage the financial aspects of the project to ensure that we are on time and on budget. Guide project team through appropriate decision-making process prior to change order being initiated.

• Bachelor's degree in a relevant scientific field with at least 6 years related experience in the CDMO or pharmaceutical industry. Higher education is highly desired
• Certification preferred (PMP, Six Sigma or equivalent).
• Equivalent combinations of education, training and relevant work experience may be considered.
• A proven experience in a project or program management role dealing with customers (ideally in a contract manufacturing organization). Typically, will have greater than 5 years industry experience in CMC and CDMO processes.
• Should possess working knowledge of pharmaceutical and biopharmaceutical product lifecycles with experience executing process development and/or commercial manufacturing programs.
• Proven expertise in timeline & budget management, communication plans, proactive risk prevention, action tracking and project plans. Experience implementing new tools and business processes to support department efficiency.
• Understands causal links between the Company's integrity policies and its value to the customer
• Open to challenge and to be challenged on ideas and opinions as part of a collaborative decision-making process. Ability to resolve conflict within project teams
• High initiative with an ability to maintain multiple priorities and initiatives effectively
• Ability to travel 10-15% if needed