Sr Mgr, CMC Purification Process Development

Unlock Your Next Big Opportunity: Senior Manager, CMC - Purification Process Development

Are you ready to take ownership of high-impact CMC work at a biotech company where your expertise will directly shape the future of novel antibody therapeutics? This is your chance to lead from the front-working with cutting-edge biologics, building strong CDMO relationships, and playing a vital role in clinical and commercial advancement.

What's in It for You?

• Lead and Influence
  You'll be the go-to technical lead for purification process development-overseeing CDMOs and ensuring quality, scalability, and regulatory success. Your insights will help guide key decisions across early- and late-stage development.

• Make a Measurable Impact
  Join a small, agile team where your work won't get lost in the shuffle. You'll be hands-on in building processes that directly support patients and drive the success of clinical programs.

• Diverse, High-Level Work
  From optimizing chromatography and ultrafiltration steps to reviewing regulatory documents and performing risk assessments-you'll engage in technically rich, meaningful work that spans from the bench to the boardroom.

• Collaboration and Visibility
  Work cross-functionally with internal stakeholders and external CDMOs, gaining exposure to global operations and regulatory strategy.

• Competitive Compensation & Long-Term Incentives

  • Base salary in the range of $150K-$180K

  • Annual performance-based bonus

  • Equity/stock options to share in the company's success

  • Full health benefits (medical, dental, vision, life, disability)

  • 401(k) with company match

  • Flexible PTO-because we believe in balance

Ideal Background for Success

• A degree (BS/MS/PhD) in Chemical Engineering, Bioengineering, Biochemistry, or a related field

• 5-10+ years of hands-on experience in biologics CMC and purification process development

• Deep understanding of chromatography, UF/DF, scale-up, and GMP transfer

• Strong communicator and collaborator with proven vendor management experience

• Experience with QbD and contributions to regulatory filings (BLA, MAA)

This is more than just a job-it's a chance to build something meaningful, lead with purpose, and grow your career in a supportive, science-driven environment. If you're excited to make an impact and thrive in a role that blends strategic oversight with hands-on execution, this could be your next great chapter.