Job Title: Manager Continuous Improvement and Production Support
- Location: Pearl River, NY
About the JobThis combination technical-leadership role combines hands-on expertise in biologics manufacturing with strategic team management to drive operational excellence across our Flublok production processes. You will lead a team of Subject Matter Experts while providing direct technical oversight of upstream and downstream operations, ensuring GMP compliance, and spearheading continuous improvement initiatives that enhance process efficiency, yield, and quality. The ideal candidate thrives in a fast-paced, regulated environment where technical problem-solving meets people development, and where your leadership directly impacts our mission to deliver life-saving healthcare solutions to patients worldwide.
Main ResponsibilitiesTeam Leadership & Development:- Lead, mentor, and develop a team of Subject Matter Experts across upstream and downstream manufacturing operations
- Manage a Continuous Improvement team focused on process optimization and operational excellence
- Coach team members on troubleshooting strategies, root cause analysis methodologies, and process improvement techniques
- Foster a culture of collaboration, accountability, and continuous learning
Manufacturing Operations & Technical Oversight:- Provide technical leadership and hands-on support for Flublok drug substance manufacturing processes
- Oversee upstream operations including cell scale-up, media preparation, and protein production
- Oversee downstream operations including purification and buffer preparation
- Ensure all manufacturing activities comply with GMP regulations and internal quality standards
- Serve as a technical resource for complex process troubleshooting and deviation investigations
Continuous Improvement & Change Management:- Drive continuous improvement initiatives to enhance process efficiency, yield, and quality
- Open, author, and drive change controls through completion in accordance with quality systems
- Lead root cause analysis investigations using structured methodologies (e.g., 5 Whys, Fishbone, FMEA)
- Identify and implement process improvements and efficiency gains across manufacturing operations
Documentation & Compliance:- Draft, review, and approve technical documents including SOPs, batch records, protocols, and reports
- Ensure documentation practices meet GMP and regulatory requirements
- Support regulatory inspections and audits as needed
About You Basic Qualifications- Bachelor's degree in biology, Biomedical Engineering, Mechanical Engineering, Biological Engineering, or related scientific discipline
- Master's degree preferred
- 7+ years of experience in biopharmaceutical manufacturing or process development, with demonstrated hands-on expertise in upstream operations (cell growth and scale-up), downstream operations (purification and buffer preparation), and analytical techniques such as chromatography.
- Minimum 3+ years of people management experience.
- Demonstrated experience in Pharmaceutical GMP manufacturing environments.
Technical Skills: - Process development experience in biologics manufacturing
- Strong background in root cause analysis and structured problem-solving methodologies
- Single Use Technology (SUT) systems and operations
- Gas chromatography and analytical techniques
- Media preparation and buffer preparation
- Protein production processes
- Cell culture and cell scale-up operations
- Upstream and/or downstream biologics manufacturing
Soft Skills- Proven ability to lead, coach, and develop high-performing teams
- Strong change control management experience
- Excellent written and verbal communication skills
- Ability to balance strategic leadership with hands-on technical support
- Strong organizational and project management skills
- Collaborative mindset with ability to work cross-functionally
Preferred Qualifications- Experience with Flublok or recombinant protein vaccine manufacturing
- Experience with insect cell culture systems (e.g., Sf9, expresSF+)
- Lean Six Sigma certification or equivalent continuous improvement training
The salary range for this position is:
$113.250,00 - $163.583,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
