Scientist (all genders) Quality Control - Microbiology

AGC Biologics

AGC Biologics

Quality Assurance
Heidelberg, Germany
Posted on Sep 5, 2024

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.

As of now, our site in Heidelberg, Germany is looking for a Scientist (al genders) in the Quality Control Microbiology department to support the team on an unlimmited contract.

Job Responsibilities:

  • QC coordinator and subject matter expert for client projects

  • Coordinate and support transfer and validation of methods

  • Writing and revision of analytical methods, ATF’s and evaluation sheets

  • Writing of deviation reports and change requests

  • Support follow up and completion of corrective and preventive actions

  • Support laboratory investigations

  • Training of new employees

  • Support analyzing of development, in-process, release and stability samples

  • Responsible for equipment for in-process testing, cell bank and API release testing

  • Support coordination of disposal for relevant analyzed samples

  • Continuous self-training and attendance of GMP and safety relevant trainings

  • Functional authority for the area of in-process testing, cell bank and API release testing

  • Project manager for genetic engineering oversight within QC of safety level 1 GMOs

Job Requirements:

  • Master or PhD in microbiology, biotechnology, pharmacy or similar subject area

  • +3 years of professional experience in a quality position

  • Experience in microbiology related testing and activities (in-process testing, cell bank testing)

  • Experience in validation of microbiological tests (e.g. Bioburden, culture purity, cell viability)

  • Good knowledge of the relevant GMP guidelines, AMWHV and regulations

  • Experience in writing Deviation reports

  • Experience with TrackWise Digital or comparable System

  • General knowledge of biotechnology production and relevant QC responsibilities (raw material testing, environmental monitoring (EM), method validation, in-process and release testing in a GMP environment)

  • Team-oriented and strong quality awareness

  • Very good German and English skills

  • German work permit is mandatory

  • Ready to take responsibility

We offer:

  • A modern working environment with exciting tasks in a future-oriented industry

  • Experienced colleagues support you during the onboarding

  • Working in an intercultural and international team with short communication channels across national borders

  • A corporate culture characterized by openness and appreciation

  • Regular company events

  • Capital-forming benefits

  • Jobticket

  • Employer allowance for lunch with Lunch-It

  • JobRad

  • Flexible working hours through a modern time tracking tool

  • Free drinks (water, soft drinks, tea, coffee) and fruit

  • Annual bonus programme

If you are interested in this role, we look forward to receiving your application via our recruitment portal.

AGC Biologics GmbH
Czernyring 22
69115 Heidelberg


Phone: 06221 / 9026-0
www.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 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.