Want to know if this job is worth applying to?
San Diego, California, United States
Onsite
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 end-to-end packaging material selection, engineering, and qualification for oral solid dose container closure systems and associated secondary and tertiary packaging, from early clinical development through commercialization and lifecycle management
Establish packaging strategies, specifications, critical material attributes, engineering and process controls, and acceptance criteria based on product, stability, patient, packaging, and regulatory requirements
Design, execute, interpret, and document packaging development, package integrity, transportation, qualification, and validation studies supporting clinical trial materials and registration stability
Lead technical assessments for CPO (contract packaging organization) selection and drive packaging site readiness for commercial launch, including line trials, packaging qualification, process validation, technology transfer, launch execution, and operational handover
Lead technical investigations for packaging related deviations, and nonconformances, and retain post launch technical ownership for lifecycle changes, troubleshooting, packaging vendors and CPO transfers, and continuous improvement in partnership with Packaging Operations
Lead packaging artwork development, including dielines, component specifications, print requirements, barcodes, serialization product requirements, and packaging line compatibility
Author and review regulatory packaging content, including container closure system information, packaging development data, technical justifications, and responses to health authority questions
Partner with internal teams and external organizations to deliver packaging programs and evaluate emerging materials, technologies, and sustainability solutions
Bachelor’s degree in Packaging Science, Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, Pharmaceutical Sciences, or a related technical field with 4+ years of relevant experience; or Master’s degree with typically 2+ years of applicable experience
Experience in pharmaceutical packaging development or packaging engineering within a cGMP-regulated environment, with working knowledge of applicable FDA and ICH guidance, USP requirements, and ASTM, ISTA, and ISO standards
Direct experience with oral solid dose packaging, including bottle and/or blister packaging systems
Experience selecting, developing, and qualifying packaging materials, primary packaging components, and container closure systems, with knowledge of moisture and oxygen barrier properties, light protection, compatibility, mechanical performance, aging, and material variability
Experience supporting packaging activities across development and commercial phases, including clinical trial materials, registration stability, regulatory submissions, commercial launch, and lifecycle management
Experience authoring and reviewing packaging content for regulatory submissions, including container closure system information, packaging development data, technical justifications, and responses to health authority questions
Experience planning and executing packaging development, package integrity, transportation, qualification, and validation studies, engineering and process controls, and acceptance criteria
Experience supporting packaging equipment, line trials, technical site assessments, process validation, technical site transfer, packaging related investigations, change controls, and CAPA
Strong technical judgment, problem-solving, project management, communication, and cross-functional leadership skills
Preferred Requirements:
Six or more years of pharmaceutical packaging development or packaging engineering experience, with demonstrated technical leadership for oral solid dose products
Experience independently leading packaging programs from early clinical development through registration, commercial launch, and post-approval lifecycle management
Experience with sachet, stick-pack, or flexible-laminate packaging, including material selection, seal development, package integrity, equipment compatibility, and line qualification
Experience developing or qualifying parenteral packaging and container closure systems, including vials, stoppers, prefilled syringes, cartridges, or other injectable product configurations
Experience developing packaging strategies for moisture-sensitive products, including desiccant systems, high-barrier blister materials, induction sealing, and moisture-protection studies
Experience with child-resistant, senior-friendly, tamper-evident, or patient-centered packaging systems
Experience leading packaging technology transfers, CPO site readiness, alternate vendor qualifications, or commercial packaging site transfers
#LI-LS1
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 $97,000.00-$133,000.00. 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 20% 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.