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.Your Contributions (include, but are not limited to):Lead strategic planning and execution of drug/device combination product development for clinical and commercial presentationsProvide technical ownership for delivery devices, primary packaging, and related combination product elements across the product lifecycleDevelop and implement innovative delivery device solutions, including prefilled syringe, autoinjector, and other injectable delivery platformsServe as the device and combination product subject matter expert on cross-functional CMC and program teamsLead technical decision-making, risk management, and issue resolution for drug/device integration, device performance, manufacturability, and lifecycle managementEnsure timely completion of development, verification, validation, manufacturing, and technology transfer deliverablesPartner with Quality, Regulatory, and external suppliers to ensure combination product strategies meet global regulatory, cGMP, safety, and quality expectationsIdentify, evaluate, engage, and manage external partners for device development, manufacturing, testing, and commercialization activitiesMonitor external innovation, emerging technologies, connected health solutions, and industry trends in injectable delivery systemsSupport integration of delivery device and drug product strategies across multiple therapeutic modalities, including peptides, proteins, antibodies, and gene therapy productsRequirements:BS/BA in Mechanical Engineering, Biomedical Engineering, or a related field, with 10+ years of industry experience, ORMS/MA in Mechanical Engineering, Biomedical Engineering, or a related field, with 8+ years of industry experience, ORPhD in Mechanical Engineering, Biomedical Engineering, or a related field, with 5+ years of industry experienceExperience developing and commercializing drug/device combination products (e.g., pre-filled syringe systems, autoinjectors) is essentialAdvanced knowledge of design controls, design verification and validation, risk management, design transfer, and lifecycle managementExperience with manufacturing scale-up, technology transfer, and external partner or supplier oversightThorough understanding of cGMP, quality systems, and global regulatory expectations for combination products and medical devices, including FDA, EMA, and applicable ISO standardsCurrent knowledge of drug delivery technologies, connected health solutions, human factors/usability engineering, and emerging trends in injectable product developmentProven ability to solve complex technical challenges, make sound risk-based decisions, and influence cross-functional teamsStrong communication, collaboration, and leadership skills in a matrixed environmentPreferred QualificationsExperience supporting regulatory filings, health authority interactions, or commercial launch readiness for combination productsExperience working with external device developers, contract manufacturers, testing laboratories, or component suppliersFamiliarity with primary container closure systems, secondary packaging, human factors engineering, and device constituent part control strategiesExperience supporting products across multiple modalities, including peptides, proteins, antibodies, or gene therapy productsNeurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.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.
Associate Engineering Director, Combination Drug Product/Device in san diego at Unknown Company
This position is listed as contract and onsite.