This position works within the Product Development team to design and develop adult and pediatric small molecule drug product formulations & manufacturing processes. This will be achieved by developing a thorough understanding of operating and performance parameters impact on quality attributes throughout the development life cycle.
ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):
Design & execute experiments (DoE) employing quality by design (QbD) principles to develop robust formulations and manufacturing processes for different phases of drug product development.
Perform pilot and commercial process scale-up for pharmaceutical products using first principles, process modeling, proper experiments, and statistical analysis.
Responsible for screening, identifying, and managing drug product manufacturing sites/technologies of oral solid dosage formulations for adults (such as Tablet and Capsule) and pediatrics (such as Oral Granules/Minitablets).
Perform process fit and select/manage contract development and manufacturing vendors.
Optimize manufacturing processes of drug products based on current regulatory guidelines related to pharmaceutical development.
Review and approve batch records, protocols and technical reports.
Provide technical assistance and act as Person in Plant (PIP) during Technology Transfer to CMO partner sites for manufacturing of different phases of clinical studies, registration stability lots, and validation batches.
Author technical documents for formulation and process development and prepare CMC sections of regulatory filings.
Work closely with other internal cross functional groups such as Analytical, QA, and Commercial teams to ensure all drug product requirements are met.
Perform FMEA and risk assessment from early stage process development to late stage commercialization.
Perform continuous process verification (CPV) of critical process parameters (CPPs) and critical quality attributes (CQAs) of marketed and under development drug products. Perform statistical analysis and conduct regular product specific data trending.
Fundamental understanding of first principles underlying drug product manufacturing processes.
Technical expertise and hands-on experiences in solid/liquid oral dose formulations and related manufacturing unit operations of small molecules such as: High Shear Wet Granulator, Fluid Bed Granulator/Dryer, Roller Compactor, Tablet compression on rotary press and with multi-tip tooling (for minitablets), Pan Coater, and Fluid Bed Coater with Wurster Column.
Experience in solid dosage pharmaceutical process development, technical transfer, scale-up and commercialization of manufacturing processes to new sites.
Experience in using 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 in project management and ability to work in a cross-functional working group.
Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the company.
Excellent verbal and written communication skills with strong technical report writing.
Enjoy working in a fast-paced and highly collaborative environment.
Ability/willingness to travel (domestic & international) to CMO partner sites up to 25%.
EDUCATION and/or EXPERIENCE:
Minimum Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, or other Life Sciences related fields.
Requires minimum of 4 years of relevant pharmaceutical industry experiences.
Employer will assist with relocation costs.
About Neurocrine Biosciences Inc.
Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological and endocrine related disorders.
At Neurocrine Biosciences - voted one of San Diego's top places to work in 2018 - we pride ourselves on having a strong, distinctive 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 patient suffering and enhance lives.