Associate Director, Supply Chain Packaging

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer.  Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 

 The Role:

Lead, develop, coordinate, and approve packaging-engineering processes at external sites. Provide technical leadership and management of sub-teams that ensure timely product launch for both domestic and international markets.

Manage project management, budget planning, vendor selection, development of new packaging component specifications and work with cross functional teams to drive projects to completion. Partner closely with many cross-functional areas and contribute to their practices to generate more efficient, cost effective and compliant processes.

Responsibilities:

• A solid understanding of packaging materials and manufacturing processes and experience in global packaging standards for drug products and combination products is required.
• Lead the innovation and packaging development activities in a cross-functional team and requires pharmaceutical packaging and product development knowledge.
• Lead the development and validation of primary, secondary, and tertiary packaging while managing due dates and project timelines to support commercial launch.
• Define and manage the serialization program enabling packaging vendors with serialization functionality.
• Provide technical leadership for developing packaging/labeling material selection, qualification, and process implementation for new product programs.
• Specify packaging materials and subsequently prepare specifications that effectively support product development and commercial operations.
• Conduct process, equipment and production validations and qualifications.
• The supply chain packaging lead will use a combination of principles of packaging technology, design engineering, to ensure right-first-time packaging design qualification.
• This position will be integral for implementing packaging technologies and the capability to support clinical and commercial packaging formats.
• This position will manage packaging development life cycle management.
• This position will play an important role and be an interphase between Clinical, Commercial Marketing and Supply Chain.
• Build and maintain relationships with key stakeholders both internally and externally.
• Support cross-functional teams in preparing for and facilitating consistent internal and external communications.
• Partner with Clinical, Commercial and Technical Operations teams on Sales & Operations Planning and align with Finance regarding budget scenarios.
• Lead Supply Chain planning activities, goals, and initiatives for Supply Chain.
• Ensures proper level of documentation and covers packaging-related aspects in compliance with regulations and cGMP.

 Competencies:

• Excellent problem solving, communication and organization skills.
• Flexibility with changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks.
• Ability to work in a collaborative environment, drive to learn and improve skills. 
• Ability to strategically plan, organize and manage multiple projects simultaneously. 
• Ability to prioritize tasks/issues and awareness to potential issues in a proactive manner.
• Strong work ethic, ability to meet deadlines and flexible on the potential occasion you may need to work outside of immediate job role or normal job hours to get the task done and meet the deadline. 

Qualifications:

• S./M.S. degree in supply chain, engineering, pharmacy, or other related discipline. MBA preferred.
• 10-15 years extensive experience and demonstrated leadership in Manufacturing and/or Supply Chain Management, with a significant component in manufacturing, development, or supply.
• 8-10+ years of packaging engineering, commercialization, pharmaceuticals sciences or another relevant engineering field within the pharmaceutical industry.
• Excellent verbal, written, and presentation skills and effectively communicate with all levels of management.
• Global drug development expertise with good understanding of other functions relevant to commercialization.
• Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking, and leadership in a matrix environment.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively commun