San Diego, California, United States · On-site
$174k–$237k/yr
Who We Are: Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-chan…
Skills: Combination Product Development, Design Controls, Device Engineering, Primary Packaging, Risk Management
San Diego, California, United States · On-site
$114k–$213k/yr
RELOCATION ASSISTANCE: Relocation assistance may be available CLEARANCE REQUIRED FOR START: No CLEARANCE TYPE: Secret TRAVEL: Yes, 10% of the TimeDescription At Northrop Grumman, our employees have incredible opportuniti…
Skills: Electromechanical Engineering, Hardware Design, CAD, Heat Transfer, Mechanics of Materials
San Diego, California, United States · On-site
Amazon Leo is Amazon's low Earth orbit satellite network. Our mission is to deliver fast, reliable internet connectivity to customers beyond the reach of existing networks. From individual households to schools, hospital…
Skills: RF Test Systems Development, Test Automation, Hardware Design, Python, MATLAB
El Segundo, California, United States · On-site
$114k–$213k/yr
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Skills: Guidance Navigation and Control, Matlab, Simulink, Autocoding, Control Law Development
San Diego, California, United States · On-site
$71k–$78k/yr
Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentia…
Skills: Aseptic Technique, Mammalian Cell Culture, Flow Cytometry, ELISA, MSD Platform
San Diego, California, United States · Hybrid
$63k–$112k/yr
Job TitleRegulatory Affairs Specialist I Job Description The Regulatory Affairs Specialist I supports regulatory activities to help ensure Philips Image Guided Therapy Devices are safe, effective, and compliant with appl…
Skills: Regulatory Affairs, FDA Regulations, EU MDR, 510(k), PMA Supplements
San Diego, California, United States · Hybrid
$92k–$138k/yr
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Skills: Regulatory Affairs, Medical Device Compliance, FDA Submissions, Labeling Review, Change Assessment
San Diego, California, United States · On-site
$71k–$78k/yr
Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentia…
Skills: Aseptic Technique, Mammalian Cell Culture, Flow Cytometry, ELISA, Data Analysis
Eureka, California, United States · Hybrid
$143k–$184k/yr
Consulting Director, Regulatory Analyst (Utilities/Power/Renewables) Are you ready to lead transformative environmental projects that power communities and drive sustainable innovation? ERM is seeking a visionary Consult…
Skills: Environmental Permitting, CEQA, NEPA, Regulatory Strategy, Stakeholder Engagement
San Diego, California, United States · On-site
$145k–$165k/yr
Company Description ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-…
Skills: Regulatory Submissions, Strategic Planning, Project Management, Clinical-Regulatory Writing, Cross-functional Collaboration
San Diego, California, United States · On-site
PURPOSE Operate the automated plasmapheresis machines, monitor donors, and ensure that donors experience a safe and successful plasmapheresis procedure. General Requirements – Adhere to all Standard Operating Proce…
Skills: Phlebotomy, Plasmapheresis, Donor Monitoring, Customer Service, CPR
San Diego, California, United States · On-site
At Apple, new ideas have a way of becoming extraordinary products and customer experiences. Bring passion and dedication to your job, and there's no telling what you could accomplish. Dynamic environment, inquisitive peo…
Skills: RF Modeling, 4G/5G/6G Systems, Matlab, C/C++, Python
San Diego, California, United States · On-site
We are scientists, engineers, and operators who have spent our careers inside cell therapy manufacturing. We have built the platforms, scaled production, and watched these treatments fail to reach the patients who need t…
Skills: Mechanical Design, CAD, Rapid Prototyping, DFM, Tolerance Analysis
San Diego, California, United States · On-site
$46k–$49k/yr
Under direct supervision, will be responsible for performing pre-analytical and assisting with the analytical procedures for patient testing. REQUIREMENTS Bachelor Degree in a Hard Scientific Field 1+ Years of experience…
Skills: Pre-analytical Procedures, Analytical Procedures, Instrument Maintenance, Quality Control, Troubleshooting
San Diego, California, United States · Remote OK
$135k–$150k/yr
Summary: The FP&A Manager will be responsible for leading and executing financial planning, forecasting, and performance analysis across the organization, with a strong focus on supporting commercial and go-to-market ini…
Skills: Financial Modeling, Budgeting, Forecasting, Performance Analysis, Commercial Finance
San Diego, California, United States · On-site
$136k–$180k/yr
Biopharma Sales Executive – San Diego About the Role The Biopharma Sales Executive will drive growth across biopharma accounts in North America. Acting as a technical sales specialist, this individual will collaborate wi…
Skills: Technical Selling, Account Planning, Consultative Sales, Relationship Management, Stakeholder Mapping
San Diego, California, United States · Remote OK
$175k–$205k/yr
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of c…
Skills: CMC Regulatory Affairs, IND/CTA Development, NDA/MAA Planning, QC Review, GMP Documentation
San Diego, California, United States · Hybrid
Uniquity Bio is a clinical-stage biotechnology company committed to putting science and patients first. We exist to develop transformative new medicines for immune-mediated diseases, and we’re looking for bright-mi…
Skills: Biostatistics, Clinical Trial Design, Statistical Analysis Plans, Regulatory Submissions, CRO Management
San Diego, California, United States · On-site
Are you passionate about applying your deep understanding of machine learning technologies and data platform skills in creative ways? Apple's iCloud Mail Intelligence Platform team is looking for an excellent Machine Lea…
Skills: Machine Learning, Big Data, Distributed Systems, Python, Java
San Diego, California, United States · On-site
$33/hr–$42/hr
Company Description About Us: Briotix Health is a leading provider of employee health and wellness solutions. Our mission is to improve the well-being and performance of workers through innovative, evidence-based practic…
Skills: Industrial Sports Medicine, Ergonomics, Injury Prevention, Early Discomfort Management, Technical Task Analysis
San Diego, California, United States • On-site
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Lead the development and lifecycle strategy for drug/device combination products, including prefilled syringes and autoinjectors. Provide technical ownership and subject matter expertise from early development through commercialization and post-approval management.
Requires a degree in Mechanical or Biomedical Engineering with 5 to 10+ years of industry experience depending on the degree level. Must have demonstrated expertise in combination product development, design controls, and global regulatory expectations.
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)
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
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
Experience developing and commercializing drug/device combination products (e.g., pre-filled syringe systems, autoinjectors) is essential
Advanced knowledge of design controls, design verification and validation, risk management, design transfer, and lifecycle management
Experience with 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
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
#LI-DM1
Neurocrine 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.
You Deserve Brave Science
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. Review our Community Guidelines: https://bit.ly/NeurocrineLinkedInGuidelines *in collaboration with AbbVie
Offices: 6027 Edgewood Bend Ct, San Diego, California 92130, US
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