Senior Scientist, MSAT

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 MSAT (Manufacturing Science & Technology)

At AGC Biologics we work at the forefront of biotechnology to bring life-saving medicines to patients worldwide. We are looking for an experienced Senior Scientist to join our Manufacturing Science & Technology (MSAT) organization and support the manufacturing of commercial biopharmaceutical products while driving continuous process improvements.

About the Department

The Commercial Stage team is a part of the MSAT department provides scientific and technical support to the manufacturing of commercial biopharmaceutical products. The department plays an important role in ensuring that manufacturing processes remain robust compliant with GMP regulations and continuously optimized throughout the product lifecycle.

The team is a compact group of experienced scientists and technical specialists with strong expertise in bioprocessing and commercial manufacturing support. Many team members serve as subject matter experts within their fields enabling the team to work independently on complex technical challenges while collaborating closely with manufacturing quality regulatory and client-facing teams.

The Role

As Senior Scientist you will support the manufacturing of complex biotechnological products and contribute to the continuous improvement of commercial processes. The role requires strong technical problem-solving skills and the ability to collaborate across functions to ensure operational efficiency product quality and regulatory compliance.

In this role you will act as the technical owner of documentation for commercial MSAT projects support process change management and post-batch evaluations and contribute to process improvement initiatives. You will lead technical assessments related to deviations support investigations and change control activities and serve as a subject matter expert in technical discussions and client project meetings. The role also includes authoring or reviewing technical sections of regulatory dossiers supporting inspections and audits and providing technical leadership and guidance across departments.

Your Qualifications

You bring a strong scientific background combined with experience supporting biopharmaceutical manufacturing processes in regulated environments.

Education and experience:

• MSc in Biochemistry Chemistry Biology Bioprocess Engineering or a related field with 6 years of relevant industry experience or

• PhD in a related discipline with 4 years of relevant industry experience

Technical expertise:

• Strong understanding of downstream processing and purification principles including interpretation of purification performance and process trends

• Hands-on experience with chromatography techniques such as affinity ion exchange hydrophobic interaction or mixed-mode chromatography including column packing performance testing and maintenance

• Experience developing scaling and validating chromatography purification methods and working with systems such as ÄKTA and UNICORN software

• Experience with ultrafiltration and diafiltration (UF/DF) and purification of biomolecules from mammalian and microbial expression systems

Professional capabilities:

• Strong data analysis skills including experience with statistical tools such as JMP or Minitab

• Solid understanding of GMP requirements and applicable regulations (e.g. ICH Q7A 21 CFR Part 211)

• Experience writing and reviewing technical documentation and supporting regulatory submissions

• Ability to collaborate across departments coordinate multiple activities or projects and provide technical guidance to colleagues

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.