POSITION OBJECTIVE: To provide the project management and team leadership for developing our generic injectable portfolio of products and management of our CMO partners. Serves as key business project leader for Athenex in aligning core managing activities leading to the successful execution of the product development programs: establish project plans with milestones and deliverables in collaboration with stakeholders (CMO, R&D, Regulatory Affairs, Supply Chain, etc.); and ensuring accountability of team members for these deliverables
Essential Job Functions/Responsibilities
· Provide direct leadership to the global project management programs.
· Evaluate prospective projects in collaboration with senior management and business development team.
· Provide project team leadership and act as key business partner, operating with a strategic, cross functional mindset.
· Critical to have knowledge of the injectable development and regulatory process for injectable products. Need to be able to help partners navigate requirements of the US FDA.
· Ability to manage multiple development programs simultaneously, across numerous CMO partners, in a fast pace environment.
· Ensure effective management of the sub-team including scheduling, agendas, minutes, action items follow-up.
· Proactively identifies challenges or potential issues for execution of the project within sub-team; manage and escalate as appropriate.
· Define the scope of the projects in collaboration with senior management and partners.
· Achieve operational objectives by contributing information and recommendations to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; resolving problems; completing audits; identifying trends; determining facility and system improvements; implementing change.
· Meet project financial objectives by forecasting requirements; preparing budgets; scheduling expenditures; analyzing variances; initiating corrective actions.
· Work directly with managers in other departments on escalations and process/procedure enhancements.
· Collaborate with cross functional teams (e.g. Operations, Regulatory, Business Development and QC) and individuals (e.g. Project Leaders)
· Accomplish human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.
· Responsible for managing, maintaining and growing key partner relationships.
· Determine the objectives and metrics upon which project management will be evaluated and report to senior management.
· Provide solutions and resolve problems and conflicts with projects.
· Develop and conduct training programs for staff as need arises resulting from project implementations.
· Contribute to achieving continuous improvement.
Required Education & Qualifications
· BS degree and 10+ years of Project Management of injectable drug development programs in the pharmaceutical industry required
· Project Management Professional certification preferred
· Complete understanding of GMP environment, capable of managing complex projects including budgets, capital spending, product transfer from R&D into manufacturing
· Experience in managing matrixed teams to achieve project goals required
· Excellent written and verbal communication skills required.
· Professional and amiable disposition and communication style needed.
· High energy level; positive attitude; Strong time management and multi-tasking skills needed.
· Strong project management skills, knowledge of project management practices in the pharmaceutical industry
· Able to work autonomously in a matrix-managed organization.
· Well-developed strategic thinking and leadership skills.
· Excellent follow through skills required.
· Presentation skills required.
· 10 to 15% travel required
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.