Associate Director, Technology Development and Transfer
1 week ago
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus 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 Lantheus 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 someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
The Associate Director, Technology Development and Transfer, acts as a technology development and transfer lead in the Manufacturing Technology and Development (MT&D) organization at Lantheus. 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 Lantheus. Ensures processes are designed and validated per applicable current Good Manufacturing Practices (cGMP’s), Lantheus procedures, and that processes are defined consistent with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and cGMP’s. 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 CMO 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 Lantheus’ 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 MT&D and 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. 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 Lantheus’ values.Typical Minimum Skills and Experience and Education
Requirements include a or in relevant scientific/technical disciplines, advanced degrees (, PhD) or technological certificates preferred but not required. 10+ years of work experience within pharmaceutical or medical device industry, 5+ years of technology development and transfer experience, within a matrixed pharmaceutical, medical device, or biotechnology organization. Previous experience working with aseptically filled/finished drug products, medical device, radiopharmaceuticals and CMO management strongly preferred.Other Requirements
Subject matter expert (SME) in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology operations. Strong knowledge of global regulatory requirements related to the design and control of these processes. Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment. Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes. Ability to work within and lead different technical teams. Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing. Excellent organizational skills and the ability to successfully manage a multitude of technical projects. Ability to work in a prompt, complex and changing environment. Excellent analytical, technical and experiences. Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills. Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired. Experience working with external partners is highly desirable. Ability to work independently in decision-making and resolution of program obstacles and conflicts. Keen insight, independent judgment and tactful discretion are required. Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”. Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Lantheus to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism. Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Lantheus and CMO locations.-
North Billerica, United States Lantheus Medical Imaging Full timeJob Description Job Description Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
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