• Technical Leadership: Provide technical knowledge, insight, project management, and leadership for the commercialization of mAb drug substances.
• Process Management: Lead the transfer of drug substance processes to and from the manufacturing facility. Evaluate and optimize processes to improve efficiency and quality.
• Troubleshooting: Lead investigations and troubleshoot process deviations, trends, and issues. Design and perform small-scale laboratory experiments and studies to support technology transfers and investigations.
• Design of Experiments (DoE): Plan, conduct, and analyze experiments using appropriate statistical tools to drive process optimization and problem-solving.
• Change Control: Create and implement corrective actions using the site’s change control process.
• Collaboration and Alignment: Collaborate with Global R&D and CMC, contract development and manufacturing organizations (CDMOs), Process Engineering, Manufacturing, Quality Assurance, and Quality Control to ensure processes are transferred and maintained effectively.
• Documentation: Author and review technical reports, process transfer summaries, and other documents. Review upstream and downstream manufacturing batch records and provide technical input to Manufacturing technical documentation specialists.
• Trending and Reporting: Maintain process databases and monitor batch-to-batch consistency of operations. Support the preparation of Continued Process Verification and Annual Product Reviews.
• Compliance: Ensure changes to processes and methods are documented and implemented in compliance with current Good Manufacturing Practice (cGMP) requirements. Write change controls, perform impact assessments, and collaborate with Quality Assurance and Manufacturing to establish and execute change action plans.
• Reporting and Presentations: Design, develop, and execute project status and data reporting. Lead discussions regarding investigations and facilitate alignment in individual and group settings.

Education

• Bachelor’s or master’s degree in Pharmaceutical Sciences, Engineering, or a related life sciences field is required.
• A master’s degree is preferred.

Experience

• Minimum of five years of purification experience in the biotechnology industry.
• Experience in Manufacturing Science and Technology (MS&T), Process Engineering, or technology transfer is preferred.
• Experience with deviations, investigations, root cause analysis (RCA), and corrective and preventive actions (CAPA).
• Demonstrated project management skills.
• Excellent analytical and communication abilities.
• Good understanding of Good Manufacturing Practices and applicable regulations and guidelines, including ICH.
• Experience starting up and operating a biopharmaceutical manufacturing facility is a plus.

Technical Skills

• Skilled in operating bench-scale laboratory equipment for monoclonal antibody processes.
• Proficient in Microsoft Office Suite, statistical analysis, and Design of Experiments (DoE).

Non-Technical Skills

• Results-oriented and comfortable navigating ambiguity, with the ability to set clear outcomes, track progress, follow through on commitments, and deliver measurable results that advance organizational objectives.
• Responsive, accountable, and efficient in managing tasks.
• Adaptable to change, with the clarity, patience, and understanding to guide teams through evolving challenges.
• Strong organizational skills, attention to detail, and work ethic.
• Culturally sensitive, with the ability to build alignment in a global environment.
• Communicates with care through active listening, consideration of others’ perspectives, and thoughtful relationship management.
• Committed to continuous learning, knowledge sharing, and personal growth.
• Promotes inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.
• Recognizes achievements and encourages a healthy work-life balance.
• Collaborates with respect, integrity, and humility, prioritizing collective success.
• Resourceful and proactive in challenging the status quo, driving innovation, and developing creative solutions.
• Applies an enterprise-wide perspective, working across functions to deliver cohesive, integrated solutions.

Physical Demands and Work Location

• Initially works at a construction site and ultimately at a biotechnology manufacturing facility in Sanford, NC.
• This position is 100% on-site and is not eligible for hybrid or remote work.

Travel Requirements

• Requires up to 20% domestic travel and limited international travel.

Compensation & Benefits

The anticipated annual base salary for this position is $135,000 to $155,000. The actual salary offered for this role at commencement of employment may vary based on several factors including, but not limited to, relevant experience, skill set, qualifications, education (including applicable licenses and certifications), job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America, we provide a comprehensive range of benefits including:

• 401(k) with Company Match
• Annual Bonus Program (Sales Bonus for Sales Positions)
• Generous PTO and Holiday Schedule, including Summer and Winter Shut-Downs
• Sick Days
• Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drug, and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long-Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.