About the Role:
In partnership with the broader CMC organization, the Associate Director of Drug/Device Combination Products will lead the development and lifecycle strategy for drug/device combination products, including prefilled syringe and autoinjector presentations. This role will provide technical ownership for delivery devices and associated primary and secondary packaging from early development through commercialization and post approval lifecycle management.

The successful candidate will serve as a subject matter expert in combination product development, design controls, device engineering, primary packaging, manufacturing readiness, and drug/device integration. This individual will work closely with cross-functional partners across CMC, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and external development and manufacturing partners to advance a pipeline of injectable products.

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Your Contributions (include, but are not limited to):

• Lead strategic planning and execution of drug/device combination product development for clinical and commercial presentations

• Provide technical ownership for delivery devices, primary packaging, and related combination product elements across the product lifecycle

• Develop and implement innovative delivery device solutions, including prefilled syringe, autoinjector, and other injectable delivery platforms

• Serve as the device and combination product subject matter expert on cross-functional CMC and program teams

• Lead technical decision-making, risk management, and issue resolution for drug/device integration, device performance, manufacturability, and lifecycle management

• Ensure timely completion of development, verification, validation, manufacturing, and technology transfer deliverables

• Partner with Quality, Regulatory, and external suppliers to ensure combination product strategies meet global regulatory, cGMP, safety, and quality expectations

• Identify, evaluate, engage, and manage external partners for device development, manufacturing, testing, and commercialization activities

• Monitor external innovation, emerging technologies, connected health solutions, and industry trends in injectable delivery systems

• Support integration of delivery device and drug product strategies across multiple therapeutic modalities, including peptides, proteins, antibodies, and gene therapy products

Requirements:

• BS/BA in Mechanical Engineering, Biomedical Engineering, or a related field, with 10+ years of industry experience, OR

• MS/MA in Mechanical Engineering, Biomedical Engineering, or a related field, with 8+ years of industry experience, OR

• PhD in Mechanical Engineering, Biomedical Engineering, or a related field, with 5+ years of industry experience

• Demonstrated expertise in medical device or combination product development, engineering, and commercialization

• Experience developing combination products leveraging complex mechanical or electromechanical delivery systems, preferably including prefilled syringes, autoinjectors, on-body delivery systems, or related injectable platforms

• Advanced knowledge of design controls, design verification and validation, risk management, design transfer, and lifecycle management

• Experience with drug/device integration, manufacturing scale-up, technology transfer, and external partner or supplier oversight

• Thorough understanding of cGMP, quality systems, and global regulatory expectations for combination products and medical devices, including FDA, EMA, and applicable ISO standards

• Current knowledge of drug delivery technologies, connected health solutions, human factors/usability engineering, and emerging trends in injectable product development

• Proven ability to solve complex technical challenges, make sound risk-based decisions, and influence cross-functional teams

• Strong communication, collaboration, and leadership skills in a matrixed environment

Preferred Qualifications

• Experience supporting regulatory filings, health authority interactions, or commercial launch readiness for combination products

• Experience working with external device developers, contract manufacturers, testing laboratories, or component suppliers

• Familiarity with primary container closure systems, secondary packaging, human factors engineering, and device constituent part control strategies

• Experience supporting products across multiple modalities, including peptides, proteins, antibodies, or gene therapy products

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The annual base salary we reasonably expect to pay is $173,600.00-$237,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.