Scientist, Senior/Principal Scientist, Quality Control

at  AGC Biologics

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.
We are looking for a Scientist or a Senior/Principal Scientist to join our QC Raw Materials team! The team consists of 12 skilled colleagues, represented by 7 scientists, 4 technicians, and a Manager.
By joining the QC Raw Material team, you will be key in implementing new raw materials to support new phase I/II projects as well as planning the Raw Material Qualification and Release Testing program for late stage projects. As part of daily release flow, you will be responsible for test planning of incoming raw materials, keeping Raw material specifications in compliance, assessing Supplier Change Notifications, as well as providing scientific solutions to contract labs.
The Department
QC Raw Materials is part of the QC organization, which consists of five departments: QC Bioassay, QC Chemistry, QC Microbiology, QC Support, and QC Planning & Systems. QC is responsible for supporting the production of various biopharmaceuticals by controlling raw materials, performing analytical testing, planning and executing stability programs and validating analytical methods according to regulatory guidelines from clinical phase I through phase III and commercial. We are also actively involved in the constant development and improvement of the work environment.

Key responsibilities

• Author and review raw material specification based on European or US regulatory guidelines as well as adapting to supplier change notifications
• Deliverance of scientifically sound and cGMP compliant raw material documents and analytical results.
• Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports
• Oversight of sampling, as well internal as outsourced testing.

Qualifications
The ideal candidate holds an MSc or PhD degree in Pharmacy, Biotechnology, Biology, Chemistry or similar, and preferably with work experience within Quality Control and/or Quality Assurance and/or Material Management.

In addition, we expect you to bring some of the following experience and characteristics:

• Profound writing and reviewing skills of cGMP documents: raw material specifications, test methods, general procedures
• Experience setting specifications for compendial and non-compendial raw materials
• In depth understanding of US and European pharmacopoeias
• Experience handling change controls, deviations and CAPAs including root cause investigation, and Laboratory Investigations
• You are an experienced multi-tasker and you enjoy working in a high pace and being challenged in a busy business
• You are a team player combined with the ability and desire to work independently
• Experience with contract manufacturing and business understanding
• Experience in representing area in Audits and Inspections

You have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience. AGC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English AGC Biologics.
Why join?
AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time.
Application
Submit your application as soon as possible. We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidate is found, the add will close. For further information regarding the position, please contact Senior Manager, Stella Brudin, QC Raw Materials, at ssbrudin@agcbio.com
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
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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

• Author and review raw material specification based on European or US regulatory guidelines as well as adapting to supplier change notifications
• Deliverance of scientifically sound and cGMP compliant raw material documents and analytical results.
• Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports
• Oversight of sampling, as well internal as outsourced testing