Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Senior Scientist, Process Optimization (Process Compliance & Documentation)

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Are you passionate about ensuring manufacturing excellence through scientific leadership and process compliance? Do you thrive in a dynamic, cross-functional environment where your expertise can drive operational improvements and inspection readiness?

At AGC Biologics, we are seeking a dedicated and detail-oriented Senior Scientist to join our Manufacturing team. In this role, you will play a key part in shaping and supporting our microbial and mammalian production processes. You bring strong communication skills, a proactive mindset, and a passion for optimizing biopharmaceutical manufacturing through collaboration, innovation, and compliance.

Job Summary

As a Senior Scientist, you will bring a deep understanding of cGMP regulations and manufacturing processes. In this role, you will serve as a Subject Matter Expert (SME), providing scientific and technical leadership across your area of responsibility. You will lead complex projects and investigations, ensuring alignment with regulatory standards and operational goals.

You will collaborate effectively with cross-functional stakeholders, offering expert guidance and support to production teams. Your responsibilities will include driving process improvements, updating standard operating procedures, and maintaining a state of inspection readiness. Utilizing project management methodologies and LEAN principles, you will support value streams and manufacturing support teams to enhance efficiency and product quality.

Essential Responsibilities

• Act as the Subject Matter Expert within your area of responsibility.
• Maintain and manage templates and procedures, ensuring they meet regulatory standards and company requirements.
• Act as the gatekeeper for effective workflows, such as supporting the development of Manufacturing Process Records (MPR) modules.
• Develop processes within the scope of the area of responsibility.
• Collaborate cross-functionally.
• Lead projects and investigations.
• Apply LEAN methodology to optimize techniques and processes within the area of responsibility.
• Identify and implement improvements to enhance efficiency and support the optimization of production processes.
• Demonstrate initiative in identifying areas for improvement and suggest solutions.
• Communicate effectively with team members and stakeholders to ensure clarity and understanding.
• Adapt to changing priorities and managing time efficiently to meet deadlines.

Qualifications

Required:

• Requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD with 1-2 years of experience.
• Proficiency in using scientific software and tools for data analysis.
• Advanced understanding of manufacturing protocols and procedures.
• Familiarity with compliance management and quality processes.
• Familiarity with cGMP (current Good Manufacturing Practices) and regulatory requirements.

Preferred:

• Education/background in Biotechnology, Biochemistry, Microbiology, or a related field.
• Knowledge of upstream and downstream processing in biopharmaceutical production.
• Experience with mammalian cell culture and/or microbial fermentation techniques.
• Experience with Manufacturing Process Records (MPR) development.
• Familiarity with LEAN methodologies.
• Experience with Power BI.
• Experience working with CAPAs.

Your Profile

You hold a degree in life sciences and bring solid experience from a cGMP-regulated manufacturing environment. You have a strong ability to balance strategic thinking with attention to detail, and you thrive in dynamic settings where priorities and structures evolve rapidly.

You are a proactive problem-solver with a positive, can-do attitude and a structured approach to your work. Your experience with LEAN methodologies and project-based collaboration enables you to drive continuous improvement and contribute effectively to cross-functional initiatives. Adaptability, strong communication skills, and a commitment to quality are key traits that define your professional approach.

Contact and Application

For any questions, feel free to contact cphhrcareer@agcbio.com.

Please note that we will only consider applications submitted via our career page.

We will review applications as they arrive.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.