Current jobs related to Associate Director, Technology Development and Transfer - North Billerica - Lantheus Medical Imaging Inc
-
North Billerica, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus 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...
-
Director, Business Development
4 months ago
North Billerica, United States Antenna Research Associates Inc Full timeJob DescriptionJob DescriptionCompany OverviewARA is a leading C5ISR company that designs, manufactures, tests, and installs innovative technologies that provide the national security community with unparalleled situational awareness, threat detection, and communications capabilities.Our disruptive, integrated solutions, assemblies and subsystems rise to the...
-
North Billerica, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob 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...
-
Executive Director of Business Development
3 weeks ago
Billerica, Massachusetts, United States PAREXEL Full timeExecutive Director, Portfolio ManagementParexel is seeking a highly skilled Executive Director, Portfolio Management to join our global Operational Excellence & Delivery team. This role will support the OED Enterprise Program Management Office (EPMO) in governing and reporting progress on internal investments, including transformational and corporate...
-
North Chicago, Illinois, United States AbbVie Full timeAbout the RoleThe Associate Director, Biologics DPD, is a key member of the AbbVie team responsible for driving the evaluation and advancement of pipeline compounds from Lead Optimization (LO) to First-in-Human (FIH) studies. This individual will oversee the development of biologics drug product research initiatives, leveraging their multi-disciplinary...
-
North Billerica, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in 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...
-
North Chicago, Illinois, United States VaaridaTech Full timeJob SummaryWe are seeking a highly experienced Director of Business Development for Medical Technology New Product Development to join our team at VaaridaTech. As a key member of our organization, you will be responsible for leading end-to-end NPI projects for MedTech, with a focus on services and/or system-based projects.Key ResponsibilitiesDevelop and...
-
Senior Director of Cybersecurity
4 days ago
Billerica, Massachusetts, United States Cabot Full timeAbout the RoleCabot is seeking a highly experienced and skilled Senior Director of Information Security to lead our global cyber and data security programs. This critical role is ideal for someone passionate about developing and implementing a robust framework for information security across the enterprise.Key ResponsibilitiesDevelop and implement a...
-
Associate Director, Quality Compliance
2 weeks ago
North Billerica, Billerica, MA , USA, United States Lantheus Medical Imaging Inc Full timeJob SummaryLantheus Medical Imaging Inc is seeking a highly experienced Associate Director, Quality Compliance to provide leadership and compliance oversight for the company's in-house and contract manufacturing activities and processes.Key ResponsibilitiesManage the internal audit program, inspection readiness, and external audits/inspections to ensure...
-
Transfer Pricing Coordinator
3 weeks ago
North Chicago, Illinois, United States KYYBA Full timeJob OverviewWe are seeking a highly skilled and detail-oriented professional to join our team at Kyyba as a Financial Intern. As a key member of our finance department, you will play a crucial role in supporting our financial analysis, transfer pricing, and costing accounting functions.Key ResponsibilitiesAssist in creating product financial flows and...
-
Senior R&D Manager
3 weeks ago
Billerica, Massachusetts, United States Cabot Corporation Full timeAbout the RoleCabot Corporation is seeking a highly skilled Senior R&D Manager to lead our Reinforcement Materials R&D team in a process technology leadership role at our technical center. As a key member of our team, you will be responsible for driving innovation and developing new process technology to improve production efficiency, increase...
-
Director of Cybersecurity and Data Protection
3 weeks ago
Billerica, Massachusetts, United States Cabot Corporation Full timeAbout the RoleCabot Corporation is seeking a highly skilled and experienced Director of Cybersecurity and Data Protection to join our Digital organization. This critical role is ideal for a seasoned professional who can lead our global cyber and data security programs and oversee the overall Information and Data security of the entire organization.The...
-
Lead Process Chemist in Manufacturing Science
4 weeks ago
North Billerica, United States Lantheus Medical Imaging Inc Full timePosition OverviewLantheus Medical Imaging Inc. is a leader in the field of medical diagnostics, dedicated to enhancing patient care through innovative solutions. Our organization is characterized by its entrepreneurial spirit and commitment to excellence, fostering a collaborative environment where every team member plays a vital role in our success.The...
-
Associate Director, Electronic Gases
2 months ago
North Smithfield, United States Linde Full timeAssociate Director, Electronic Gases (EG) Business Processes -24001470 Description Linde Gas & Equipment Inc. Associate Director, Electronic Gases (EG) Business Processes Location: Hampton, NJ Linde Gas & Equipment Inc. is seeking an Associate Director, Electronic Gases (EG) Business Processes to join our team! What we offer you! ...
-
Director of Operations and Development
3 weeks ago
North Hollywood, United States Food Forward, Inc Full timeJob SummaryFood Forward, Inc. is seeking a highly motivated and experienced nonprofit leader to fill the role of Associate Director, Operations & Annual Giving. This position will play a critical role in solidifying the organization's growth trajectory by enhancing the operational efficiency of the Development team.Key ResponsibilitiesDepartment...
-
Director of Information Technology
2 weeks ago
North Syracuse, United States CPS Recruitment Full timeDirector of Information Technology$110-125K DOECPS Recruitment has an outstanding opportunity for an experienced Director of Information Technology in the North Syracuse, NY area.In this role, you will lead and direct a team of 3, supporting system infrastructure for a well-established and stable manufacturing company. You and your team...
-
Director of Information Technology
2 days ago
North Bergen, United States MadRag Full timeAbout UsFor 50 years, MadRag has been bringing on-trend fashion to budget-conscious women who have a bold sense of style. With more than 100 stores in 14 states, MadRag is the "go-to" destination for today’s most fashion-forward shoppers. We take pride in our history of making fashion size-inclusive and accessible to all and the customer is at the heart of...
-
Director of Information Technology
1 week ago
North Bergen, United States MadRag Full timeAbout UsFor 50 years, MadRag has been bringing on-trend fashion to budget-conscious women who have a bold sense of style. With more than 100 stores in 14 states, MadRag is the "go-to" destination for today’s most fashion-forward shoppers. We take pride in our history of making fashion size-inclusive and accessible to all and the customer is at the heart of...
-
Clinical Development Director
5 days ago
North Chicago, Illinois, United States AbbVie Full timeJob SummaryWe are seeking a highly skilled Clinical Development Director to oversee the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs.Key ResponsibilitiesParticipate in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting...
-
North Chicago, United States Selective Service System Full timeAs a basic requirement for entry into the SES, each applicant must provide evidence of progressively responsible executive leadership and supervisory experience. The evidence must be directly related to the skills and abilities outlined under Executive Core Qualifications (ECQs) and Mandatory Technical Qualifications (MTQs) listed below. The ideal...
Associate Director, Technology Development and Transfer
4 months 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 B.S. or M.S. in relevant scientific/technical disciplines, advanced degrees (e.g., 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.
