Sr. Principal Scientist, Prod Dev – Late Stage

Research and Development Group               ·                US CA San Diego (On site)            ·           Full-time

Remote type: On-Site
Locations: US CA San Diego
Time type: Full time
Job Requisition ID: R3945

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose – to relieve suffering for people with great needs, but few options.

What We Do:

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

About the Role:

Supports design, development, and execution of strategies for the CMC Product Development group to progress large molecule and biologics programs (including peptides) from preclinical lead optimization stage through clinical development to commercial. Develops and expands the “state of the art” in both the formulation science and process design & engineering disciplines, required for late stage for Phase-2 through to commercial product launch. Responsibilities include provide scientific leadership for implementing QbD (Quality by Design) and RM (Quality Risk Management) elements for development of Neurocrine Biosciences biomolecule drug product candidates during late-stage clinical studies, registration stability studies, regulatory submission, process validation, and commercial life cycle.

Your Contributions (include, but ate no limited to):

• Develops key strategies to execute late-stage biomolecule product development efforts
• Supports build talent/expertise for all team members by involving them in the right projects and ensuring for use of appropriate process development tools
• Supports commercial process scale-up for pharmaceutical products
• Utilizing Design of Experiments (DoE) to map and qualify operational spaces within robust & reproducible processes that deliver products with the target performance attributes
• Develops and executes DP/DS stability programs, and shelf-life re-evaluations
• Works with cross-functional product-focused teams within Development, CMC, and with external partners to progress development objectives and implement strategic directives
• Proactively researches drug product manufacturing processes based on current regulatory and ICH guidelines for modern pharmaceutical development
• Plays key execution role in commercial launch of NBI drug products, overseeing Process Validation related activities
• Directs the transfer Process Validation from PD to CMSC
• Authors, reviews, and approves product-related CMC sections for IND and BLA filing
• Responsible for all process development related activities and CMOs results, including Technology Transfer to CMO partner sites for manufacturing of different phases of clinical studies, registration stability lots, and validation batches
• Work closely with the peers across multiple cross functional groups such as Analytical, QA, Regulatory, and Commercial teams to ensure all drug product requirements are met
• Assesses risk and determines mitigation strategies from early stage process development to late stage commercialization
• Oversees continuous process verification (CPV) of critical process parameters (CPPs) and critical quality attributes (CQAs) of marketed and under development drug products according to ICH Q8, Q9, and Q10
• Represents Neurocrine externally by attending/actively participating in scientific conferences and interacting with industrial and academic groups
• Other duties as assigned

Requirements:

• Bachelor’s degree in Chemical Engineering and 15+ years of pharmaceutical industry experience, including solid dosage pharmaceutical process development, technical transfer, scale-up and commercialization of manufacturing processes to new sites, development of Amorphous Solid Dispersion for solubility enhancement and modified release applications; extensive experience statistical analysis software and risk assessment tools; Extensive previous managerial experiences also required OR
• Master’s degree in Chemical Engineering and 13+ years of similar experience noted above OR
• PhD in in Chemical Engineering and 10+ years of similar experience noted above
• Expert understanding of first principles underlying drug product manufacturing processes for biomolecules
• Ability to lead people for both technical and non-technical matters
• Proven track record authoring/supporting regulatory documents including IND and/or BLAs
• Technical expertise and deep hands-on experiences in biomolecule drug products  process development- including formulation and fill finish,  technical transfer, scale-up and commercialization of manufacturing processes to new sites
• Ability to synthesize statistical data into insights and recommendations
• Working knowledge of statistical analysis software and risk assessment tools to implement the Quality by Design (QbD) elements during product life cycle
• Understanding of ICH, FDA, EMA guidance in CMC and Quality areas
• Enriched knowledge of cGMP requirement for drug product development and manufacturing
• Experience attending FDA meetings and direct FDA interaction during PAI is a plus
• Author / review protocols, SOPs and reports
• Technical experience in developing formulation and drug product process of LM/biologics, including process scale-up from in pilot plants to GMP production required.
• Proficient in using biophysical and biochemical characterization techniques for biologics drug candidates.
• Experience in designing, executing and interpreting biologics drug product development studies including high throughput pre-formulation screening, forced degradation, formulation development and process characterization.
• Experience in designing, executing and interpreting clinical in-use studies.
• Experience in DS/DP stability program and shelf-life re-evaluation
• Experience of applying analytical methods of biologics to stability, in-use study and DP analysis is a plus.
• Proactive, innovative, with good problem-solving skills
• Ability to work in a cross functional team and matrix environment
• Excellent written, presentation, and verbal communication skills

#LI-DM1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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 $146,300.00-$212,150.00. 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.

Please click here to apply.