Symphogen is currently experiencing an increase in activities within both the early and late stage projects. Furthermore, Symphogen is planning to start phase III clinical trials, and to apply for a Manufacturing and Import Authorization (§39 Licence).
Symphogen therefore plan to strengthen the QA organization with a Quality Manager.
As Quality Manager you will be involved in every step of the manufacturing process from generation of cell banks, upstream and downstream processes, final formulation, filling, analysis and release of the final drug product. The manufacturing is outsourced to various CMO's in EU and US.
The Quality Manager will participate for the quality group in our projects covering process- and analytical validation, PPQ, clinical supply, and eventually marketing application.
Tasks and Responsibilities
The responsibilities include, but are not necessarily limited to:
- Support the development of Symphogen QMS to ensure compliance with EU and FDA GMP
- Supervision of GMP manufacturing of clinical trial material including review and approval of qualification and validation protocols and reports, master batch records, SOPs, and other documents
- Support planning, conducting and following up on external audits of suppliers and CMOs
- Release of drug products for clinical trials in the EU and US, initially for clinical trials, and eventually commercial use
- Execution of internal audits in both production, laboratory and IT areas
- Compliance with all relevant GxP guidelines including GLP, GMP, and GCP
- Supervision of internal and external process development activities to ensure compliance with ICH guidelines Q8 and Q9
- Participation in development of the company's lead candidate to prepare for process validation and eventually marketing application
The ideal candidate:
- Has a university education in life science (MSc or similar) fulfilling the requirements for Qualified person
- Has preferably 5-10 years relevant experience from the biopharmaceuticals industry
- Has profound current GMP knowledge, including familiarity with the current FDA, EMA, and ICH guidelines within the biopharmaceutical area
- Has experience with GMP manufacturing of biologic API and drug products for clinical trials
- Has experience in auditing according to GMP, preferably a lead auditor
- Has experience in technical transfer of processes and analysis, preferably in collaboration with R&D staff
- Professional English oral and in writing
- Is a strong communicator, who is able to be flexible and cooperative
- Is honest and openminded
- Has a good humor and interest in peoples relations and teamwork
Working in Symphogen
When being a part of Symphogen you will always have a challenging job in a creative, goal oriented, value-based biotech environment with a meaningful mission. You will be a part of a highly engaged organization with a passion of being the worldwide leading recombinant polyclonal antibody company.
You will have good development opportunities, in an organization that is inspiring and growing, with focus on diversity, teamwork, commitment and you as a person.
For further information
For more information please contact QA Director, Marianne Sort at +45 2447 9171 or HR Coordinator, Pia Holm Olesen at +45 4526 5050. Please also see www.symphogen.com for more information about our company.
If you are interested in the position, please mark your application and CV "Quality Manager" and email it to: firstname.lastname@example.org no later than February 18, 2018. Potential candidates will be invited for interview as they apply and we reserve the right to terminate before the posting expires.
We look forward to hearing from you!
Antibody therapeutics is currently the fastest growing business in the pharmaceutical industry. Following the historical success of monoclonal antibodies, Symphogen is striving to develop and commercialize superior antibody mixtures based on the diversity of the natural human immune system by use of Symphogen's proprietary technology suite. Symphogen A/S has built an innovative oncology pipeline consisting of mAbs and mAb mixtures, and performs activities from early discovery to mid-stage clinical development, which translates into new and challenging opportunities for our organization and employees. Symphogen is located in Ballerup in the greater Copenhagen area. The company currently employs approximately 110+ people.
Developing symphonies of antibodies require an orchestrated mix of scientific disciplines. Symphogen is fortunate to employ a dynamic team of hardworking, passionate scientists and professionals committed to advancing the frontier of antibody therapeutics.
We offer a professionally challenging working environment to candidates with the right skill set within antibody immunotherapy, molecular biology, antibody discovery, and protein expression. Preferred applicants for scientific positions should hold a minimum of three years post-doctoral research experience within oncology.
Should you possess such skills, we invite you to join a vibrant discovery and development culture that strives for excellence and innovation for pioneering achievements in the world of antibody mixtures.
We encourage qualified candidates to send their CV by e-mail to email@example.com.