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Sanofi Group
Cambridge
**Job title: Device Regulatory Lead (Associate Director)** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and in-vitro diagnostic products within the Sanofi portfolio of products.
Job Source: Sanofi GroupVertex Pharmaceuticals
Boston, MA, United States
Associate Director, Manufacturing Operations - Devices page is loaded Associate Director, Manufacturing Operations - Devices Apply locations Boston, MA time type Full time posted on Posted 30+ Days Ago job requisition id REQ-21661 Job Description General Summary: The Associate Director, Manufacturing Operations
Job Source: Vertex PharmaceuticalsAlnylam Pharmaceuticals
Cambridge, MA, United States
Work_Category - hybrid Description Overview The Director, Device Platform Management manages a team of Scientists/Engineers to develop and execute implementation strategy for primary containers, devices, and combination products at Alnylam. Scope of work includes establishing and driving the implementation of device, primary container, and c
Job Source: Alnylam PharmaceuticalsShine Associates
Boston, MA, United States
DIRECTOR/ASSOCIATE DIRECTOR, DEVELOPMENT POSITION SPECIFICATION Shine Associates, LLC has been retained to search, identify and recruit a Director/Associate Director, Development on behalf of our client (‘Company’). This person will report directly to the Senior Director, Development. This candidate will be located in the Boston, MA office. CONFID
Job Source: Shine AssociatesElucent Medical, Inc.
Boston, MA, United States
Job Title: Area Director Reports to: Chief Commercial Officer EDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS · Bachelor’s degree · Five years of Medical Device Experience and/or business-to-business sales experience required · Capable of standing for multiple hours at a time · Capable of lifting up to 50 pounds on occasion · OR experience
Job Source: Elucent Medical, Inc.HiFiBiO Therapeutics
Cambridge, MA, United States
Associate Director/Director of Business Development - Antibody Therapeutics Company Overview HiFiBiO Therapeutics is a clinical-stage biotech driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pione
Job Source: HiFiBiO TherapeuticsAtavistik Bio, Inc.
Cambridge, MA, United States
Associate Director, Business Development Atavistik Bio is focused on unlocking hidden functional pockets to discover transformative allosteric precision therapeutics to address serious unmet patient needs. By integrating our propriety screening technology using the body’s natural regulators, with our powerful AI-enabled drug discovery platform, w
Job Source: Atavistik Bio, Inc.Atavistik Bio
Cambridge, MA, United States
Company Summary: Atavistik Bio is focused on unlocking hidden functional pockets to discover transformative allosteric precision therapeutics to address serious unmet patient needs. By integrating our propriety screening technology using the body's natural regulators, with our powerful AI-enabled drug discovery platform, we are able to efficiently
Job Source: Atavistik BioBoston, MA, United States
Role Summary
Apogee Therapeutics is seeking an Associate Director, Device Development to join the Technical Operations team to provide technical leadership in developing first class patient-centric biologic/device combination products for Apogee’s programs. Products include prefilled syringes with needle safety device, autoinjectors, and on-body injectors.
As a technical leader in an emerging company relying on a fully outsourced supply chain, the Associate Director, Device Development will act as a subject matter expert (SME) in biologic/device combination product design and development, technology transfer, and cGMP manufacturing oversight. This position will work closely with external suppliers, manufacturers and with other functional areas in Technical Operations and Quality to ensure development and manufacture of high-quality combination products to support clinical supply and commercial manufacturing.
Key Responsibilities
Technical lead on cross-functional teams responsible for development of combination products
Work with Quality function to establishment design controls procedures for combination product development
Author product-specific design control documentation, including User Requirements Specifications, Design Input Requirements, and Design Verification plans, protocols, and reports
Oversee test method development, test method validation and design verification at external labs
Establish human factors strategies
Work with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to meet development, manufacturing, and supply goals
Review and approve manufacturing protocols, master and executed batch records, validation plans and reports, and other cGMP documents
Support person-in-plant during manufacturing at CMOs, as needed
Serve as technical SME in root cause analysis and deviation investigations
Author, review, and approve development studies and technical reports
Collaborate effectively with cross-functional teams, including analytical development, supply chain, quality assurance, and regulatory affairs
Serve as technical SME on due diligence and business development opportunities
Communicate findings and progress through presentations and reports
Author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.)
Ideal Candidate
Minimum 10 years of relevant industry experience, BS in mechanical engineering, chemical engineering, biomedical engineering, or a related field required, advanced degree a plus
Must have hands-on experience in developing biologic/device combination products, specifically with prefilled syringe with needle safety device, autoinjector, and/or on-body injector. Experience should include:
Development of User Requirements and Design Input Requirements
Establishing statistical acceptance criteria based on reliability and confidence intervals
Statistical analysis of test data
Test Method Validation
Design Verification plans, protocols, and reports
Design Validation and Design Transfer
Process Validation
Experience in late phase clinical development and commercialization of combination products
Must have sound understanding of current regulatory requirements and industry standards for biologic/device combination products, including 21CFR820.30, ISO 13485
Experience working with external device suppliers and CMOs and cGMP manufacturing facilities
Experience performing risk management per ISO 14971
Experience with execution of root cause analysis and investigations
Strong communication and presentation skills
Availability to participate in calls across multiple international time zones
Ability to travel up to 25% domestically and internationally to vendor / CMO sites and company meetings
Ability to work independently and multi-task in a fast-moving organization
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
The anticipated salary range for candidates for this role will be $170,000 - $185,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
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Email Alert for Associate Director, Device Development jobs in Boston, MA, United States
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