Senior QC Equipment Scientist, QC Planning & Systems

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 QC Equipment Scientist
Are you looking for an exciting job in an expanding international company producing new biological medicines? Do you thrive in a dynamic environment, in a department with skilled colleagues in an organization where we work as one team? Then, we have the ideal opportunity for you! Quality Control at AGC Biologics is looking for an experienced and quality-minded Senior Scientist for our QC Equipment department.

About the organization
At AGC Biologics A/S (AGC), we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing. Since we are a contract manufacturing development organization, a high level of service to our clients is in focus.

The QC organization consists of 160 dedicated colleagues, and we are responsible for supporting the production of new biopharmaceuticals by performing analytical testing of samples from the production and stability programs and validating various analytical procedures.

AGC is growing - we have built a new facility next to our existing facility in Søborg. To support the expansion of the QC laboratories, we have established the QC Equipment department. This department is growing as well! The department is owner of all equipment in QC and responsible for life cycle management activities such as preparation of URSs, procurement, qualification, maintenance, (re)qualification/calibration, and decommissioning. All activities are performed in compliance with cGMP.

Role and responsibilities
As Senior Scientist in QC Equipment, you will be responsible for ensuring that analytical instruments for our new facility is qualified in due time to allow expansion of our analytical capacity. As you will be authoring qualification documentation you will be responsible for understanding the context, and scope, of URS, IQ, OQ, and PQ. Primary scope is qualification of analytical instruments related to our various analytical methods; this includes HPLCs, CEs, ELISA readers, SoloVPE, qPCR instruments etc. Furthermore, you will also be responsible for procurement and qualification of other types of equipment like water baths, pipettes, balances etc.

The position requires hands-on experience with instrument maintenance. All work in the department is performed under cGMP and you will be responsible for finalizing service reports and enter work performed in the equipment database.

Qualifications
The ideal candidate holds a degree in Biochemistry, Chemistry or relevant area - a MSc or PhD degree could be an advantage. Also, we expect you to bring knowledge on equipment qualification from the pharmaceutical industry, so the ideal candidate has a minimum 3-5 years of work experience from a similar position.

In addition, we are looking for the following competencies:

• (Technical) experience with life cycle management of analytical equipment such as HPLC, iCIEF, CE-SDS, ELISA readers, SoloVPE, and qPCR instruments
• Experience with working in cGMP settings according to European and US regulatory guidelines.
• Experience in writing Change Controls, URS, IQ/OQ documents and SOP´s related to analytical equipment.
• Capacity to prioritize your own tasks in a dynamic environment.
• Good communication and interpersonal skills
• You are a team player but work independently.
• Ability to interact positively within a team and in close collaboration with other working areas when needed.

It is important to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. Furthermore, you thrive in a challenging and dynamic environment and enjoy a rapid pace of work. You bring a positive, can-do attitude and a good sense of humor.

Application
For further information regarding the position, please contact Manager Johan Bollhorn, QC Equipment, at [email protected]. We treat the applications as we receive them and conduct interviews with qualified candidates. When the right candidates are found, the add will close.

AGC offers
AGC offers a dynamic working place with good opportunities of working with a varied array of manufacturing tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent be able to plan your daily work yourself. AGC offers an informal working environment, where humour is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude, and we help each other to reach deadlines together as one team.

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.
Location: Copenhagen Site