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 who can assimilate new information quickly and enjoys working closely with others within a fast-paced environment. 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.
What will you do?
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, equipment purchase and qualification, and preparation for non-GMP activities.
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 Lexington technical team, and customer team. Report on the initially agreed upon customer and internal milestone sharing progress, issues, and risks.
Identify potential project risks with the team and develop mitigation strategies, report progress, blocking issues, and risks to all stakeholders. Know when to advance issues to senior leadership for resolution.
Demonstrate role model leadership in the execution of PM standard work and customer centric behavior.
Track and manage the financial aspects of the project including milestone payments, pass through costs and FTE estimates to ensure that we are on time and on budget. Guide project team through appropriate decision-making process prior to change order being initiated.
How will you get here?
Education/Experience
Bachelor's degree in a relevant scientific field with at least 6 years related experience in the CDMO or pharmaceutical industry or related industry. Advanced degree is highly desired: MS with 4 years related experience.
Certification preferred (PMP, Six Sigma or equivalent).
A proven experience in a project or program management role dealing with customers (ideally in a contract manufacturing organization), managing programs with significant business impact.
Skills & Knowledge
Should possess working knowledge of pharmaceutical and biopharmaceutical product lifecycles with experience executing process development and/or commercial manufacturing programs.
Significant experience leading cross-functional teams to deliver on-time and on-quality.
Experience in biopharmaceuticals is strongly preferred.
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
Strong understanding of financials analysis, forecasting, tracking, and reporting for projects vs. the allocated budget.
Able to connect with all levels in small and large group settings and influence actions to get output results within a matrix environment.
Pragmatic, proactive yet flexible approach in the working environment
Able to lead teams in a high paced, constantly evolving environment while maintaining order and a larger picture perspective.
Able to interact and connect with internal and external senior management explaining topics/decisions in the appropriate context.
Demonstrated ability to present ideas persuasively and negotiate effectively.
High initiative with an ability to maintain multiple priorities and initiatives effectively
Ability to travel 10-15% if needed
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.
Lexington, Massachusetts
Full Time