“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company In accordance with applicable law, company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”:
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
- GMP manufacturing experience
- Strong interpersonal skills as interactions will be both internal and external facing with CMOs
- Excellent verbal and written communication skills up, down and through matrixed environment including external facing with CMOs
- Responsible for working with cross functional teams internal to this company and external facing to building integrated tech transfer project plans to deliver key milestones for company programs
- Partner with internal and external cross functional teams to manage all NPI related meetings, minutes, action items, escalations and drive decision making process
- Execution and adherence to ACDM NPI business processes and operating model
Pharmaceutical, Biotechnology experience is a MUST
As part of the companyContract Manufacturing Business Operations and Strategy team, the Technology Transfer (TT) Project Manager will be responsible for coordinating NPI/tech transfer project as well as key continuous development initiatives and life-cycle projects in the network of functions, which includes Operations, Supply Chain, Quality, Process Development and Finance. This is a unique opportunity for top professionals to join our progressive international organization, pioneer and leader in the development and commercialization of life-changing medicines.
These activities may include analyzing opportunities, project scoping and chartering, project strategy, process mapping and definition, process improvement and change management activities. In addition, the TT Project Manager will be responsible to align and integrate the performance management processes and systems across the organization and advance our culture of Operational Excellence.
The role includes leading cross-functional teams to support the development of consistent, robust processes and systems to ensure quality and supply reliability with our contract manufacturing network and will include partnering and close collaboration with Contract Manufacturing Organizations (CMOs).
Standardization and continuous improvement activities are a primary focus for this stimulating and challenging role. Contract Manufacturing’s strategy is to embody continuous improvement and mature the lean culture to build strong long-term partnerships with external and internal stakeholders.
Role and Responsibilities
- Manage multiple cross-functional TT and New Product Introduction (NPI) projects of medium to high complexity to CMOs and ensure adherence to TT business process
- Oversee the activities of all operations aspects involved in TT and NPI to CMOs to ensure a robust transfer.
- Partner with internal and external cross functional teams, manage TT related meetings, minutes, action items, escalations and drive decision making process
- Coordinate creation/update of TT related documents
- Project management of resource planning, generating metrics/ KPIs and presentation materials for management reviews and governance meetings
- Enhance process alignment and driving strategic discussions in management and among the site teams.
- Responsible for building project plans and team assignments using Gantt charts, estimating project cost and adhering to budget, directing and monitoring work efforts daily, identifying resource needs, performing business quality reviews, and escalating functional, quality, timeline and cost issues appropriately.
- Utilize project management processes, software and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards and meet internal and external customer expectations.
- Coordinate communication with all areas of the enterprise that impact scope, budget, risk and resources of the work being managed
- Lead continuous improvement projects that deliver measurable gain in quality, efficiency and alignment within company. Apply the knowledge, skills, tools of project management / Operational Excellence (OE) to ensure optimal execution of projects and continuous improvement initiatives.
Doctorate degree in Life Science with Project Management experience
MBA with proven Project Management experience
Master’s degree and 4 years of Project Management experience
Business operations or bachelor’s degree and 6 years of Project Management experience
"This posting is for Contingent Worker, not an FTE"
- Managed and led 2 years leading medium to complex projects, comfortable with change.
- Knowledge of business principles, product development and commercialization or R&D in a life science, pharmaceutical, biotechnology, medical device cGMP environment.
- Excellent leadership, interpersonal skills, and influencing skills vertically and horizontally with integrity. Process oriented with business acumen.
- Strong organizational skills, strategic networking, self-motivation, collaboration and flexibility.
- Has demonstrated the courage and ability to solve technical problems and challenges in Teams.
- Has proven communication skills (presents confidently and convincingly at all level of the organization).
- Expert skills in lead and managing people and team’s management of diverse cultures and geographic locations, conflict resolution with diplomacy.