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.
The position as QC Bioassay Manager is responsible for leading a team of seven employees within the Quality Control department of AGC Biologics Heidelberg. This role entails the management and oversight of analytical testing of Bioassay Methods for Proteins and Nucleic Acids, including PCR, ELISA, Endotoxin, UV/VIS spectroscopy, and compendial methods (EP/USP/JP) under GMP as well as oversight and management of CAPEX projects for the Bioassay sector. Furthermore, it includes all aspects of personnel leadership, such as employee development, performance management, and resource planning.
Education/Training:
PhD or Master’s degree, or an equivalent qualification (e.g., Diplom or Staatsexamen), in Biochemistry, Biotechnology, or a comparable field with at least 5 years of professional experience in an industrial, GMP-regulated environment (ICH/FDA/EMA), preferably in the bioassay field (ELISA, PCR, electrophoresis)
Experience/Knowledge:
Experience in personnel management and team organization
Experience with TrackWise Digital and LIMS is an advantage
Knowledge of protein and DNA analytics, e.g., PCR, ELISA, UV/VIS spectroscopy, endotoxin, and compendial methods according to EP/USP/JP
Ability to work in a team, a sense of responsibility, and quality awareness are required
Knowledge of project management
Excellent communication and presentation skills
Fluency in German and English is required
Proficiency in MS Office
We offer:
A modern work environment with exciting tasks in a future-oriented industry
Teamwork within an intercultural and international environment, with short communication channels across borders
A corporate culture shaped by openness and mutual respect
Regular company events, capital-forming benefits, a public transport ticket (Jobticket), bike leasing (JobRad), employer subsidies for lunch via Lunch-it, and a modern time tracking system with flexitime account
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.
Skills Required
- PhD or Master's degree in Biochemistry, Biotechnology, or comparable field
- At least 5 years of professional experience in a GMP-regulated environment
- Experience in personnel management and team organization
- Knowledge of project management
- Fluency in German and English
- Proficiency in MS Office
- Experience with TrackWise Digital and LIMS is an advantage
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.
