Senior Engineer, Oral Solid Dose Packaging Development

Neurocrine Biosciencesis 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 companys diverse portfolio includes FDA-approved treatments for tardive dyskinesia chorea associated with Huntingtons 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 and follow the company onLinkedInX 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

• Bachelors 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 Masters 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

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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 dont line up to exactly what we have outlined in the job description.