Sr. Manager, CMC Biologics - Upstream

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we've been guided by our passion for not settling for "ordinary" in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow uson LinkedIn and Instagram.

JOB SUMMARY:

The Senior Manager, CMC Biologics - Upstream will lead development, optimization, and scale-up of upstream processes for monoclonal antibody (mAb) programs. This role oversees cell line development, media and feed strategy, bioreactor operations, and technology transfer to pilot and manufacturing sites. The ideal candidate brings strong scientific depth in mammalian cell culture, proven leadership within GMP, and the ability to drive technical strategy across multiple programs utilizing phase appropriate strategic implementation from Research and Development through late-stage and commercialization. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

Leadership & Management

• Lead and mentor associates in upstream cell culture and bioreactor operations.
• Set clear technical and operational priorities across early and late-stage biologics programs.
• Foster a collaborative, high-performance culture focused on scientific rigor, quality, and continuous improvement.

Upstream Process Development

• Oversee design and execution of experiments related to:
  
  
  
  • Cell line expansion and characterization
  • Media and feed optimization
  • Fed-batch bioreactor processes
  • Process robustness, scale-up studies, and characterization
  • Process Control Strategy for Process Performance Qualification
  
  
  
  
• Drive data-based decisions using DoE, multivariate analysis, and process modeling tools.

Technical Strategy & Cross-Functional Collaboration

• Develop upstream process strategies supporting IND-through-commercial development timelines.
• Partner with Biology/Discovery groups to advance candidates into development.
• Partner with internal and external downstream, analytical, and manufacturing teams to ensure efficient process integration.
• Provide subject-matter expertise during regulatory filings, audits, and responses to health authority questions.
• Guide risk assessments, troubleshooting, and complex deviation investigations.

EXPERIENCE & QUALIFICATIONS:

Required:

• D. in Chemical Engineering, Biochemistry, Cell Biology, or related field with 4+ years of experience or M.S./B.S. with 8+ years of relevant industry experience.
• Strong expertise in mammalian cell culture systems (CHO) for monoclonal antibody production.
• Hands-on experience with bioreactors (bench scale to pilot/clinical scale), media/feed development, and upstream process characterization.
• Experience with statistical design tools (e.g., JMP, Mini-Tab) and data analysis platforms.
• 25% travel, some International travel required (e.g., China, Europe).

Preferred:

• Knowledge of late-stage development, process characterization, and PPQ.
• Familiarity with QbD principles, CMC strategy, and regulatory submission authorship.
• Understanding of PAT tools, automation platforms, and digital data systems (e.g., DeltaV, OSI PI).
• Track record of successful technology transfer to CDMOs or within internal manufacturing sites.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.