Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
Position will act as Emergent’s technical subject matter expert for Emergent’s commercial Auto-Injector(AI) platforms. Position will be responsible for assessment of current commercial operations tooling including design, preventative maintenance, identification of user needs, specification development, prototyping, test development, design verification & validation testing, risk assessments and equipment development oversight. Individual will also oversee tech transfer of new and current process systems to support manufacturing activities and to develop manufacturing processes for high volume and throughput.
Position will also hold responsibilities for development and management of AI manufacturing strategies including manufacturing plan development, make or buy analysis and final assembly strategy to support the Companies overall AI business unit strategy.
- Works within an integrated team to provide medical device product and manufacturing subject matter expertise to advance products from concept to commercialization
- Knowledgeable, Hands On experience, and a thorough understanding of Mold Design, Mold Tooling, Mold Construction and Mold Maintenance for plastics and metal stampings
- Take ownership for the design and development of commercial component molds and related tools, with emphasis toward designs that enhance or improve moldability and reduce cost
- Assist and lend expertise in problem solving activities on existing production activities.
- Analyzes, designs, develops solutions to engineering challenges associated with Injection Molded plastic parts
- Recommends material specifications/standards for use in commercial manufacturing including resins, metals, container closure systems, packaging etc.
- Establishes machinery standards for processes and products
- Leads process improvements using modern manufacturing tools and methods
- ApplyLean manufacturing techniques to continuously improve cycle times and process flows. Identifies, and supports the execution of process improvement efforts
- Uses LEAN and Six Sigma tools to improve processes to maximize efficiency and effectiveness – focus on internal and external manufacturing operations to reduce COGS
- Responsible for developing 3-5 year tooling maintenance expenditure forecasts including budget oversight
- Will have responsibility to develop and deliver engineering documents, conduct engineering reviews and may be involved with implementation oversight including mold validations and FAT protocol development
- Applies statistical analysis techniques to quantify current process capabilities
- Participate in Design Reviews, DFMEAs, FMEAs and periodic status review meetings on new programs with Advanced Manufacturing Development
- Interpret production drawings using Geometric Dimensioning and Tolerancing (GD&T) and how to properly apply it to yield the desired fits between joining parts
- Assist investigation of device failures to determine root cause and corrective action
- Assist process development activities, write work instructions, and develop in process inspection procedures
- Act as the Liaison between Development and Commercial functions ensuring smooth transition to commercial operations
- Supports technical transfer of device production between manufacturers as necessary
- Follow and adhere to standard work
- Responsible for development and execution of companies long term strategic manufacturing/sourcing strategies to ensure corporate targets and margins are obtained
- for auto-injector business
- Lead Identify and implement device manufacturing strategies. Understand life cycle costs and cost benefit analysis. Apply continuous improvement methods to enhance yield, consistency, performance, capacity, etc. of equipment and processes
- Provides technical and operational input into the device manufacturing strategy and product life cycle documentation
- Develop 5 – 10 year manufacturing strategy that balances maximization of the Emergent Business Unit assests and External Manufacturing support that meets Emergent’s Enterprise Risk model
- Identify and recommend manufacturing investment opportunities (CapEx) to support growth/product forecasts
- Assist with the design and selection of tooling and production equipment for successful execution of Manufacturing Strategy
- Identify and recommend the best enterprise business proposition, develop a project plan, and then deliver the project plan to achieve business results
- Proactively identify and escalate risks and issues to relevant stakeholders; lead development and delivery of tactical and achievable mitigation and contingency planning. Lead teams in use of ongoing risk management & communication tools.
- Prepare risk mitigation plans and cost-effective strategies to ensure continuous product supply
- Support new product scale-up, process optimization, technology transfer and process validation activities and support manufacturing engineers in ensuring products are designed for manufacturability and that assembly and testing processes and designs are compatible for new product technology transfer and establish future process and manufacturing technology
- Knowledge of Good Manufacturing Practices (cCMPs) 21 CFR part 820required
- Knowledge of ISO 13485 Design Control and ISO 14971 Risk Management for Medical Devices preferred
- Maintain Product and Process FMEAs and otherrisk management tools in accordance with ISO 14971 and other applicable regulations.
- Responsible for development and implementation of Engineering Change system
- Maintain Design History File
- Oversee evaluation of changes (component, product, process) post design transfer for impact on manufacturing process, documentation and design control elements. Work with manufacturing site, R&D, and Quality to assess risk/impact based on Design History Files, and in accordance with Design Controls
- Support and guide Regulatory Affairs and Quality Assurance with Regulatory Submissions
- Ensures that manufacturing procedures and appropriate levels of process control are in place and meet regulatory GMP's. Brings regulatory compliance questions and issues to the attention of management as necessary.
- Development of Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports.
- Collaborate with Quality and Compliance during supplier audits, in accordance with CFR 820 and other applicable global regulations
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- Candidate must possess a minimum of a Bachelor's or advanced degree in Mechanical, Chemical or Plastics Engineering is required. Master’s degreepreferred.
- 10+ years in proven track record in drug delivery device design, development, and commercial operations.
- Thorough knowledge of quality systems, Quality by Design, validation, design transfer, and quality engineering principles for devices and combination products
- Thorough knowledge of industry standards and FDA/EMEA regulatory guidance on combination products and medical devices, specializing in auto injectors
- Strong communication skills both verbal and written including ability to present to Sr. Management and global Health Authorities in support of GMP audits, 510K/BLA approvals
- Experience in high volume injection molding and associated tooling, materials and machinery
- Experience with glass and metal stamping components is preferred.
- Demonstrable knowledge of drug delivery devices including auto-injectors, injection pens, reconstitution and dissolution devices, patch/pumps, pre-filled syringes, inhalers or other novel injection technologies
- Experience leading Manufacturing process improvements for efficiencies gains, cost savings initiatives to reduce costs and implement innovations utilizing new technologies.
- Able to study manufacturing plans, forecasts, and product specifications to create COGs models
- Is flexible on work hours and travelrequired to support international manufacturing sites and mold suppliers. Key Relationships / Customer Expectations (Optional) Key Leadership Behaviors (Optional)
- Bi-lingual skills. German is strongly preferred.
- Experience working with global team
- Proficient data analysis skills and mastery of statistical tools in problem solving
- Final Packaging / Temperature sensitive packaging validation experience is a plus
- Formulation and aseptic filling expertise of parenteral products a plus