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.
This is a Senior Development Scientist position in the Downstream Process Development group. Primary responsibilities include development of processes and characterization for GMP manufacturing, client management, and technology development. In addition, management and scientific mentoring of junior personnel, and helping to support and manage laboratory and equipment operations.
PRINCIPAL RESPONSIBILITIES:
- Coordinate downstream development activities leading to clinical and commercial manufacturing for multiple client projects
- Work with clients and internal project teams in the successful completion of contract manufacturing projects
- Present data at client project teams and written reports
- Take a leadership role within the department for developing downstream processes:
- Design downstream processes capable of scaling to GMP production in the AGC manufacturing environment
- Develop, coordinate, and communicate experimental plans within the department
- Execute and manage DoE modeling of critical protein purification processing, and bench scale experiments
- Manage large data sets and provide technical guidance to others in the analysis and interpretation of data
- Write contract manufacturing development reports, characterization development protocols and characterization reports.
- Coordinate activities and experiments with project management, manufacturing, upstream development, and analytical development
- Provide technical support to manufacturing during large scale manufacturing campaigns
- Contribute to the overall operation of the lab and infrastructure improvements
- Provide technical support in the laboratory as necessary
- Implementation of new equipment and technology
- Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives
KNOWLEDGE, SKILLS & ABILITIES:
- Background in downstream purification development and process characterization
- Excellent technical writing and presentation skills
EDUCATION/EXPERIENCE:
- BS/MS with 10+ years of experience, or PhD or equivalent and 5+ years of experience. Equivalent education and specific experience may substitute for stated requirements
- Demonstrated experience in protein purification and process characterization
- Evidence of supervisory, technical guidance and Project leadership
- Experience with JMP or other statistical analysis tools would be beneficial
- Experience with process validation activities and knowledge of large-scale manufacturing activities in a GMP environment
COMPENSATION RANGE:
$125,000 - $197,000
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.
Top Skills
What We Do
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells.
Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle.
We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance.
Visit www.agcbio.com to learn more.
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