Associate Director, Combination Product Development
4 days ago
Scholar Rock is a pioneering biopharmaceutical company dedicated to discovering, developing, and delivering innovative life-changing therapies for individuals suffering from serious diseases with high unmet needs. Leveraging its expertise in the biology of the transforming growth factor beta (TGF?) superfamily, the company is committed to advancing cutting-edge treatments that have the potential to transform the standard of care for various conditions, including neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformative role.
Job SummaryScholar Rock is seeking a highly motivated and innovative Associate Director to join its dynamic growing team. This role will provide oversight of combination product development with a keen focus on device development, including characterization testing, design verification testing, and human factors/usability engineering. The ideal candidate will report to the Head of Drug Delivery Systems and collaborate closely with key internal and external stakeholders to revolutionize drug development and enhance patient lives through innovative dosage and drug delivery systems.
Key Responsibilities- Technical lead responsible for overseeing Design Control, Risk Management, and Usability/Human Factors Engineering.
- Leverage comprehensive knowledge of relevant guidance, regulations, standards, and industry best practices in the design and development of medical devices and combination products.
- Lead technical efforts to evaluate appropriate device technologies by conducting exploratory research to gather user insights and design trends, translating user needs into product and system-level requirements and specifications.
- Provide expertise in use-safety engineering and usability risk management throughout the product development process, ensuring compliance with internal processes and external standards.
- Develop and maintain essential documentation, including Design and Development Plans, Design History Files, and Traceability Matrices. Actively participate in and drive Design Reviews, Design Control Boards, and Design Change controls.
- Onboard and manage vendors for Human Factors, User Research, and Visual Design. Develop Usability Engineering files in compliance with IEC and ISO standards.
- Design and execute Human Factors studies to evaluate product user interface, including hardware, software, packaging, instructional material, and training.
- Apply sound understanding of combination product regulatory requirements to compile CMC sections for IND/IMPD/BLA.
- Drive program execution excellence while ensuring efficient and timely escalation of urgent issues/risks to leadership.
- Develop and implement robust testing strategies to assess the performance, safety, and efficiency of combination products.
- Ensure compliance with relevant regulatory guidelines and standards (e.g., FDA, EMA) throughout the product development lifecycle.
- Stay abreast of emerging trends, technologies, and regulatory changes in the drug-device combination product field.
- Manage multiple projects simultaneously, ensuring timely delivery of milestones.
- Advanced degree (PhD, MEng, MS) in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline with 7+ years of relevant industry experience in device integration and development, combination product development, or advanced drug product development with a major pharmaceutical, biotechnological, or generic pharmaceutical company.
- Demonstrated experience in combination product development, including pre-filled syringes, pre-filled cartridges, auto-injectors, on-body devices, and novel devices for delivering complex formulations.
- Understanding of system thinking (drug+ primary container+ device+ software/app) and experience with human factors/usability engineering.
- Experience with the development of connected devices is desirable but not required.
- Strong expertise in experimental design, statistical analysis, and data interpretation.
- Experience working within device standards: Design Controls (21CFR 820.30), Risk Management (ISO 14971); Quality Management (ISO 13485); Needle-based injection systems (ISO 11608-1); Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); EU Medical Device Requirements (EU MDR 2021); Medical Electrical Equipment (EN 60601) and related requirements ISO 11040, ISO 3951, and ISO 2859.
- Proven experience with IND/IMPD/BLA filings and maintaining Design History Files for combination products.
- Strong analytical and problem-solving skills, with the ability to think creatively and innovatively.
- Excellent communication and interpersonal skills, with the ability to work effectively in a multidisciplinary team environment.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
-
Cambridge, Massachusetts, United States Scholar Rock Full timeAbout Scholar RockScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins, the company is focused on advancing innovative treatments where...
-
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
-
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
-
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
-
Cambridge, Massachusetts, United States Biogen Full timeJob Title: Senior Principal Combination Product Quality EngineerBiogen is seeking a seasoned Senior Principal Combination Product Quality Engineer to serve as an Associate Director within our Quality, Combination Products, and Devices team.Key Responsibilities:Provide comprehensive quality oversight for the lifecycle management of combination products.Lead...
-
Regulatory Advisor for Combination Products
4 weeks ago
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly skilled Regulatory Advisor to join our team at Takeda. As a key member of our regulatory team, you will be responsible for developing and implementing innovative regulatory strategies for combination products in the US market.Key ResponsibilitiesDevelop and implement regulatory strategies for combination products in the US...
-
Principal Combination Product Quality Engineer
11 hours ago
Cambridge, Massachusetts, United States Alnylam Full timeJob Title: Principal Combination Product Quality EngineerThis role is considered a hybrid position, combining technical and leadership responsibilities.Job Summary:The Principal Combination Product Quality Engineer will provide quality assurance support to Combination Product Design and Development, Design Transfer, and on-market support. This role will work...
-
Cambridge, Massachusetts, United States Alnylam Full timeJob Title: Principal Combination Product Quality EngineerThis is a hybrid role that requires a strong understanding of quality assurance principles and practices in the development and manufacturing of combination products.Key Responsibilities:Lead quality oversight and provide QA strategy for combination product design and development programs.Provide...
-
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
-
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryTakeda is seeking a highly skilled and experienced Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations to join our team. As a key member of our regulatory affairs department, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and drug-device...
-
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryTakeda is seeking a highly experienced Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations to join our team. As a key member of our regulatory affairs department, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and drug-device combinations.Key...
-
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryTakeda is seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing innovative regulatory strategies for device and combination product submissions.Key ResponsibilitiesDevelop and implement global regulatory strategies...
-
Associate Director, Development Operations
4 days ago
Cambridge, Massachusetts, United States Harvard University Full timeJob Title: Associate Director, Development OperationsHarvard University is seeking an Associate Director, Development Operations to support the Institute's ambitious fundraising efforts. The Associate Director will report to, and partner with, the Director of Development to develop funder journeys that build solid and lasting donor relationships, develop and...
-
Director of Process Development
4 weeks ago
Cambridge, Massachusetts, United States Arbor Biotechnologies Full timeAbout the RoleWe are seeking a highly skilled and experienced Director of Process Development to join our team at Arbor Biotechnologies. As a key member of our Process Development team, you will be responsible for developing, establishing, and driving the execution of our organization's process development and technical operations.You will lead the...
-
Associate Director of Development
3 weeks ago
Cambridge, Massachusetts, United States Harvard University Full timeJob Title: Associate Director of DevelopmentHarvard University is seeking an experienced Associate Director of Development to join our team. As a key member of our development staff, you will play a critical role in securing comprehensive philanthropic support for the American Repertory Theater (A.R.T.) through strategic fundraising efforts.Key...
-
Associate Director, Analytical Development, CMC
3 weeks ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeJob Title: Associate Director, Analytical Development, CMCAgios Pharmaceuticals is seeking a highly motivated and experienced Associate Director, Analytical Development, CMC to join our growing CMC team. As a key stakeholder within analytical development, you will be responsible for building and leading the analytical development function within CMC and...
-
Associate Director of Process Development
10 hours ago
Cambridge, Massachusetts, United States Vor Bio Full timeUnlocking Cancer Treatment through Innovative ScienceVor Bio is seeking an Associate Director/ Director of Process Development to join our Process and Analytical Development group. As a key member of our team, you will oversee the design, development, and characterization of gene edited hematopoietic stem cells (eHSC) and CAR-T manufacturing processes to...
-
Associate Director for ERP Systems Production
4 hours ago
Cambridge, Massachusetts, United States Harvard University Full timeJob Title: Associate Director for ERP Systems ProductionJob Summary:The Associate Director for ERP Systems Production will lead a fundamental restructuring of the production unit, responsible for configuring, scripting, testing, scheduling, and maintaining several hundred term-based batch workflows for the Extension and Summer Schools.Key...
-
Cambridge, Massachusetts, United States Foghorn Therapeutics Full timeJob Title: Associate Director, Analytical Development and Quality ControlFoghorn Therapeutics is seeking an experienced Associate Director to lead our Analytical Development and Quality Control functions. As a key member of our team, you will be responsible for driving the development and validation of analytical methods, ensuring the successful advancement...
-
Associate Director, Analytical Development
3 weeks ago
Cambridge, Massachusetts, United States Adaptimmune Full timeJob SummaryWe are seeking an experienced Associate Director to lead our Analytical Development work within the Autologous T-cell Process and Analytical Development group at Adaptimmune. The successful candidate will be responsible for leading the development and optimization of analytical assays, as well as the tech transfer of release and characterization...
