What are the responsibilities and job description for the Principal Scientist & SME Validations, QC Chemistry position at AGC Biologics A/S?
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 motivated by method validations, troubleshooting and supporting analytical QC activities in order to support clinical and commercial manufacturing for our Customers worldwide? Do you thrive in an international environment where teamwork and collaboration are on top of the agenda? Then we might have just the right opportunity for you!
The QC Chemistry Department
QC Chemistry is one of five departments in the QC area. QC Chemistry is responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial. QC Chemistry have a close collaboration within the QC area and with departments across the organization as well as AGC Biologics external Customers and external vendors.
Role & responsibilities
As Principal Scientist and subject matter expert for validations in QC Chemistry, it is required that you have expertise and ability to troubleshoot on chromatographic methods, especially (U)HPLC, iCIEF and CE-SDS. You will be driving PhI/II and PhIII/Commercial method validation activities, function as advisor and go-to person for other QC Scientists, stakeholders and Management as well as review Batch release- and Stability analytical set-ups. You will provide input for Health Authority requests, run Lab Investigations, Deviations/CAPAs and CR cases as well as authoring SOPs and provide advisory support to lab technicians. Since you will participate in method relevant Customer meetings and provide input and advice for validation plannings, good communication skills are essential together with a general understanding of planning and coordination of activities.
Your Profile
The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or other relevant area and has minimum of 8 years of work experience in analytical development or quality control organizations. Candidates with experience from PhIII Validations will have an added advantage.
In addition, you bring the following experience and characteristics for the role:
- Working and troubleshooting experience with SE-, IEX- and RP-UHPLC, iCIEF and CGE-SDS analysis.
- Experience with Chromeleon software and LIMS
- Technical experience in protein analytics testing and protein biochemistry
- Experience in validating analytical methods according to ICH guidelines for PhI/II and/or PhIII
- Experience with working in cGMP settings according to European and US regulatory guidelines
- Excellent communication, presentation, and interpersonal skills
- You like to share your knowledge and communicate openly and professionally both internally and with external customers
- You are able to prioritize both your own tasks as well as the tasks of others in a dynamic environment
- You are a team player with ability to work independently
- Fluent in written and spoken English
It is important to have a self-motivating personality with a pragmatic, solution oriented approach to the daily work, without compromising quality. Furthermore, you thrive in a dynamic environment and enjoy a rapid pace of work where we all work as one team. You bring a positive, can-do attitude and a good sense of humor.
Your Application
Submit your application as soon as possible! We treat the applications as we receive then, and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.
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.
