Senior Scientist, CMC Downstream Process Development

Neurocrine Biosciences • San Diego, CA

2d • $110,800 - $151,000 • Onsite

About The Position

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. This role will lead downstream process development activities at bench and pilot scales, while supporting scale-up, technology transfer and implementation at external manufacturing facilities. The successful candidate will bring deep technical knowledge and hands-on experience in purification technologies, biologics process development, bioconjugation process development, and manufacturing. Working in a collaborative, cross-functional environment, you will strengthen technical capabilities and contribute to the development of best-in-class biotherapeutics.

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+ industry experience preferred OR PhD in chemistry, biochemistry, biophysics, biology, or similar scientific discipline and 0 years of 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
• Demonstrated ability to operate and troubleshoot laboratory and pilot-scale chromatography skids and other bioprocessing equipment (e.g., AKTA and Repligen systems)
• Strong working knowledge of chromatography and filtration technologies
• Strong working knowledge of process development and scale-up strategies
• Strong laboratory and productivity skills
• 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
• Builds 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

Nice To Haves

• 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

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
• Provide 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree