Scientific Director, CMC - Product Development
Full Time
San Diego, CA 92130
Posted
Job description
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:
Develops strategy and drives execution of operational plans to meet commitments for the Product Development (PD) group within CMC. Provides technical leadership, direct coaching, and career development opportunities for a group of 10 (6 direct reports) with responsibilities across NBI’s therapeutic areas in small-molecule, large molecule, and biologics modalities. Oversees drug product formulation and process development for a wide variety of oral and parenteral drug products from Phase-1 through Phase-4. Effectively and efficiently deploys resources to satisfy demands for clinical product supply, data generation and new IP creation. Key responsibilities include providing scientific leadership for implementing QbD (Quality by Design) paradigm for development drug product candidates throughout clinical development, registration, regulatory submission, process validation, and commercial life cycle.
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Your Contributions (include, but not limited to):
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Serves as lead SME for the product development of large molecule & biologics products, including peptides, antibodies, and gene therapies
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Collaborates with other CMC experts and external partners to teach the art and science of formulation and process development for large molecules and biologics to PD team
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Provides scientific and administrative leadership of the PD team; allocates and prioritize resources in a budget-minded fashion, collaborates widely on scientific and business issues
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Develops key strategies to execute product development efforts both internally and in collaboration with external CDMO partners
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Builds talent/expertise for all PD team members and creates growth opportunities by deploying them to the right projects after ensuring they are positioned for success from a know-how perspective
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Directs the utilization of Design of Experiments (DoE) to map and qualify operational spaces within robust & reproducible processes that deliver products with the target performance attributes
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Directs the application of appropriate modeling techniques to understand and predict the impact of API properties & physical characteristics on product biopharmaceutical performance, stability, manufacturability, etc.
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Supports life-cycle management of marketed products, including product enhancements, line extensions, and continuous process improvement/verification initiatives related to routine commercial product resupply
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Reviews and approves product-related sections for IND, IMPD, CTA, NDA, BLA, PAS, and CBE-30 submissions globally
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Works 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
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Assesses risks and determines mitigation strategies from early stage process development to late stage commercialization
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Ensures PD team has access to all necessary resources for career development and technical growth and provides leadership and continuous mentoring/coaching on that front
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Other duties as assigned
Requirements:
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Bachelor's degree in Pharmaceutical Sciences, Pharmaceutics, or related scientific discipline and 20+ 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 solid dispersions for solubility enhancement and modified release applications; extensive experience statistical analysis software and risk assessment tools; Extensive previous managerial experience also required OR
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Master's degree in in Pharmaceutical Sciences, Pharmaceutics, or related scientific discipline and 15+ years of similar experience noted above OR
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PhD in in Pharmaceutical Sciences, Pharmaceutics, or related scientific discipline and 12+ years of similar experience noted above
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Technical expertise and deep hands-on experiences in solid oral dose drug products unit operations for both conventional and enabled formulations; large molecule experience a plus
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Deep understanding of biopharmaceutics and pharmacokinetic principles, formulation development and pharmaceutical material sciences, and drug product performance factors impacting in vivo performance and manufacture.
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Strong knowledge of development of technological approaches for solubility enhancement and modified release performance via a variety of different approaches
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Extensive knowledge of solid dosage pharmaceutical process development, technical transfer, scale-up and commercialization of manufacturing processes at external CDMO sites
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Proven track record authoring regulatory submissions (including NDAs) for approved NCEs
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Working knowledge of statistical analysis software and risk assessment tools to implement the Quality by Design (QbD) elements during product life cycle
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Thorough understanding of ICH, FDA, EMA guidance in CMC and Quality areas
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Enriched knowledge of cGMP requirement for drug product development and manufacturing
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Experience attending FDA meetings and direct FDA interaction during PAI
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Leader with extensive experience collaborating with internal and external partners across geographies to build and advance strategies and deliver impactful business outcomes.
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Demonstrated success leading teams of >10 people and cross-functional, business-critical projects.
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Proven ability to positively impact team culture and to demonstrate flexibility in a fast-paced environment.
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Strong mentor and coach. Dedication to encouraging diverse and inclusive environments.
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Creative problem-solver who can influence diverse teams to align on strategy.
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Impeccable organizational skills. Outstanding written and verbal communication skills.
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Excellent computer skills (e.g. Word, Excel, PowerPoint, Teams).
#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.
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The annual base salary we reasonably expect to pay is $181,400.00-$290,200.00. 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 35% 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.
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