Teamlead (fmd) MSAT Process Validation

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.

Your Mission

We are seeking a passionate and experienced leader to join our Process Development team as the MSAT Team this pivotal role you will be the driving force behind bringing new client projects to life guiding them from technology transfer to successful GMP manufacturing at our Heidelberg site. You will champion scientific excellence lead a talented team and ensure our processes are robust and continuously improved throughout their entire lifecycle.

Your Key Responsibilities

• Team Leadership & Development:Lead mentor and develop a high-performing team of MSAT specialists. Drive the efficiency structure and continuous improvement of the groups operations.
• Technology Transfer & Process Introduction:Act as the primary technical lead for transferring complex bioprocesses from clients or other AGC sites. Conduct thorough manufacturability assessments including process design facility fit and risk analysis to ensure seamless integration.
• Process Excellence & Lifecycle Management:Oversee all Process Validation (PV) activities from planning and execution to final reporting. Champion Continued Process Verification (CPV) and process optimization initiatives and provide scientific expertise for process characterization studies.
• Client & Regulatory Partnership:Serve as a key technical point of contact for our clients confidently leading communications and supporting on-site visits. You will prepare and support the technical sections of regulatory dossiers and actively participate in health authority audits and inspections.
• Cross-Functional Collaboration:Partner with the Business Development team to assess the feasibility of new client proposals. Support GMP manufacturing by leading deviation investigations providing scientific assessments for change controls and defining user requirements for new process equipment.

Your Profile

• A Masters degree in a relevant scientific discipline with a minimum of 5 years of industry experience or a PhD with a minimum of 3 years of experience in a cGMP environment.
• Deep expertise in Good Manufacturing Practices (GMP) and a thorough understanding of applicable regulations (e.g. ICH Q7A 21 CFR Part 211).

Core Technical Competencies:

• Extensive hands-on experience inProcess Validation (PV)andContinued Process Verification (CPV).
• Strong background inbioprocess engineering including process design fermentation and chromatography.
• Proven track record of authoring reviewing and approving formalGMP documentation.

Leadership & Project Management:

• Demonstrated success in leading technical teams and a passion for developing talent.
• Exceptional ability to manage multiple complex projects simultaneously coordinating across departments to meet ambitious deadlines.
• Excellent communication and stakeholder management skills with a proven ability to build effective working relationships with both internal teams and external partners.
• Proficiency with MS Office and statistical software (e.g. JMP) is required.
• Preferred:Knowledge in regulatory filings and submissions.

What We Offer

• A chance to make a tangible impact on bringing life-changing therapies to patients worldwide.
• A key leadership role with strategic responsibility and the opportunity to shape and grow a critical team.
• A collaborative dynamic and international work environment where you can live the AGC Biologics Core Values.
• Significant opportunities for professional development and career growth within a leading global Contract Development and Manufacturing Organization (CDMO).

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 2500 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.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.