Associate Director, Technology Development and Transfer (Springfield)

About Us

Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someones health is in our hands. We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Purpose

The Associate Director, Technology Development and Transfer, acts as a technology development and transfer lead in the Tech Ops organization at Evergreen Theragnostics. This position will lead and manage the Manufacturing Science and Technology (MSAT) team at Evergreen. This role will be accountable for the technical work between internal and external stakeholders to ensure design, development, and transfer of robust manufacturing processes for new products and key lifecycle injectable pharmaceutical finished products. This role will be the principal expert and process owner for the end-to-end manufacturing process for injectable pharmaceutical finished products at Evergreen Theragnostics. Ensures processes are designed and validated per applicable cGMPs, Evergreen Theragnostics procedures, and that processes are defined consistent with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating / maintaining associated tech development transfer business processes.

Key Responsibilities / Essential Functions

• Leads technology development and transfer projects for key lifecycle injectable radiopharmaceutical products, including the establishment of the process / parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities.
• Leads a team of engineers / scientists to execute the development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms.
• Leads a team of engineers / scientists to Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies (PCS).
• Designs, prepares, and reviews technology transfer protocols, methods / processes, experimental or authoring plans or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes with internal and external stakeholders.
• Partners with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage.
• Partners with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics business growth.
• Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from sending sites for an optimized manufacturing process.
• Leads, motivates, mentors, and develops team members to exceed and meet company goals.
• Develops and maintains effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities.
• Leads a team of engineers / scientists to own QEs (i.e. Change controls, Investigations, CAPAs, Protocol & report writing)
• Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders.
• Requires approximately ~20% travel.
• Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment.
• Reports and takes initiative to correct safety and environmental hazards.
• Actively demonstrates Evergreen Theragnostics values.

Typical Minimum Skills and Experience and Education

Other Requirements