Biomedical Scientist As Cell Bank Specialist

GlycoThera Pharmaceutical Services is a leading global service provider for contract development and analytics for biotherapeutics at all stages of product life cycle. With our expertise in the development of biologics (recombinant proteins such as monoclonal antibodies, cytokines and hormones), manufacturing sciences, analytics, quality control and regulatory strategy we support a broad range of clients globally, from emerging biotech startups to leading global pharmaceutical companies.

For our site in Julich (Germany) we are looking for a highly motivated specialist to join our Cell Line Development team.

**Cell Banking Specialist (M/F/d)**:
**(full-time, permanent)**:
We are striving for innovative and efficient approaches to process development and welcome fresh thinking combined with solid skills. You will be part of a team that values respect, trust, reliability and positivity.

**Main area of responsibility**:

- Follow the timelines for cell banks´ productions and characterization activities.
- Presenting the cell banking related activities on project specific meetings and to senior management.
- Organizing the selection of production and characterization site
- Organizing the order of production and characterization activities.
- Oversight of production and characterization activities at the vendor and participate in possible deviation solving.
- Participate in setting up the cell bank production procedure.
- Review of Cell Bank characterization results and related records.
- Follow the characterization assays at the vendor according to Study plans.
- Ensure work is conducted according to regulatory guidelines.
- Support preparation of Cell Bank CoA and release.
- Archival of the cell bank related documents.
- Participate in the creation of Specifications with acceptance criteria, ensuring characterization meets regulatory requirements.
- Participate in organization of shipments of cell banks.
- Responsible for response coordination in audits/inspections, questions from the authorities.
- Authoring of relevant regulatory documents.
- Creation of reports
- Analytical data collection, interpretation and ensuring proper documentation of experimental data.
- Provide technical training as needed.
- Provide technical support where required.
- Identifying required document changes and updating of quality documentation through change control process
- Be aware of and comply with current EHS policies.

**Required experience**:

- University degree in a relevant scientific discipline (life sciences such as biology, biomedical sciences, virology, biotechnology, biochemistry, genetics etc.).
- Previous experience with working with cells in GMP environment in pharma industry.
- Knowledge of industry regulatory requirements and knowledge of viruses and/or genetic techniques expected.
- Previous experience with running/leading projects
- Excellent written and verbal communication skills

You are a smart, proactive and solution-driven scientist with a hands-on attitude who is able to independently progress projects, prioritize tasks adequately and work against tight timelines. At the same time you maintain a high quality standard in your work, support the team and foster a sense of positivity. The team´s success is your success.

**Language**: English, German is highly beneficial.
**Work Experience**: Industrial work experience (biotechnology/biopharma) is highly appreciated

**What we offer**:
Our Julich site with currently 40 employees offers an innovative, vibrant and multicultural environment that gives you the chance to bring in all of your competencies, and together with a highly motivated team drive the change and develop personally. We believe in a culture of respect, trust, reliability and positivity.