Senior Scientist, CMC Downstream Process Development

About the role

We are seeking a highly motivated and detail-oriented Senior Scientist/Engineer to join our Biologics Process Development team and advance Neurocrine’s antibody and bioconjugate assets from early preclinical development through commercialization.

Responsibilities

• Independently design and execute scalable purification process for Neurocrine biologics assets across diverse modalities including monoclonal antibody, bispecific, APC (antibody-peptide conjugate), AOC (antibody-oligonucleotide conjugate), and others
• Serve as a downstream process development subject matter expert, leading the selection, optimization and troubleshooting of chromatography resins and modalities (e.g., affinity, AEX, CEX, HIC, MMC), as well as filtration processes
• Support process scale-up, technology transfer initiatives, contract manufacturing activities and external interactions as assigned
• Contribute to the continued evolution and improvement of internal platform purification processes
• Drive documentation excellence by authoring and reviewing protocols, technical reports and raw data to ensure data quality and compliance
• Contribute to scientific analysis to support process development and program decisions
• Evaluate and implement improvements to enhance product quality and manufacturing consistency
• Identify process challenges and perform troubleshooting activities within assigned scope
• Promote and ensure a safe and compliant laboratory work environment
• Mentor junior scientists and support team development
• Perform other duties as assigned

Requirements

• BS/BA degree in chemistry, biochemistry, biophysics, biology, or similar scientific discipline and 4+ years of relevant experience OR
• MS/MA degree in chemistry, biochemistry, biophysics, biology, or similar scientific discipline and 2+ years of industry experience preferred OR
• PhD in chemistry, biochemistry, biophysics, biology, or similar scientific discipline and relevant experience
• Hands-on experience with downstream processing unit operations, including chromatography (e.g., affinity, IEX, HIC), membrane-based separation (e.g., depth filtration, UF/DF) and column-packing is required
• Strong working knowledge of chromatography and filtration technologies
• Strong working knowledge of process development and scale-up strategies
• Strong laboratory and productivity skills
• Experience with APC, AOC, siRNA and AAV is preferred
• Manufacturing experience internally or with external partners is preferred
• Experience with high-throughput platform is preferred (e.g., Tecan)
• Experience and knowledge of protein characterization and analytical techniques is preferred (e.g., SEC, SDS-PAGE, CE, ciEF)
• Knowledge of DOE and statistical data analysis is preferred
• Familiarity with cGMP requirements is preferred
• Strong knowledge of scientific or engineering principles and methods
• Demonstrated ability to interpret complex data sets and articulate scientific rationale
• Consistently recognizes anomalous results and determines appropriate next steps
• Explains data implications clearly to cross-functional stakeholders
• Buils effective internal and external working relationships
• Detail oriented with strong analytical thinking
• Works effectively as part of a team and may lead defined activities
• Strong communication skills
• Understands broader scientific impact on project outcomes
• Manages multiple deadlines with accuracy and efficiency
• Demonstrates developing project leadership skills

Benefits

• Annual base salary range: $110,800.00 - $151,000.00
• Annual bonus with a target of 20% of the earned base salary
• Eligibility to participate in our equity based long term incentive program
• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans