Product expert Jobs in Schönkirchen

Job Description :

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy : disease.

Ferring+You

You will be part of the Global Manufacturing Technology and Science (MTS) department which is at the interface between the development and the manufacturing operations, supporting a given product and / or process including analytical methods, prior to, during and post- commercialization. MTS ensures that the processes perform as developed and validated while ensuring continuous improvement through the application of scientific expertise. As a Subject Matter Expert Biologicals (m / f / d) , you will work on various biological analytical methods projects. You will be the go-to person for all subjects related to biological assay (compendial requirements, validation / verification, transfer, troubleshooting. Your overall focus will be to provide technical and scientific expertise through partnerships with the relevant departments of multiple sites, global functions, and third-party laboratories to introduce and maintain robust biological analytical methods for GMP release of biological products. The primary focused assays will be potency, and activity assays but will also include a variety of other analytical methods such as, process and host-cell residuals testing, quantitative ddPCR methods, infectivity assay, compendial method verification.

With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs.

Your day at Ferring

Identify and lead initiatives on bioassay robustness.

Lead, design, and follow-up experimental studies with third-party laboratories.

Support the introduction, implementation, and validation of bioanalytical methods into the manufacturing organization for GMP release.

Drive and or support troubleshooting activities related to bioassays using root cause analysis tools.

Support / drive part of the 3Rs program (Replacement, Reduction and Refinement)

Advocate best practices for specific biological analytical methods.

Participate in cross-functional projects as bioassay SME team member.

Author and maintain relevant SOPs, guidelines, and tools.

Create, maintain, expand, and continuously update scientific knowledge-based on the technologies in scope.

Behind our innovation…There’s you

Master of Science or equivalent, in a relevant field such as cellular biology, virology, immunology.

A minimum of 5 years of knowledge in biological analytical methods for biologics and large molecules.

Subject matter expert for biologicals methods in accordance with cGMP, ICH guidelines and pharmacopoeia requirements.

Solid technical skills and experiences in :

Potency assays (Cell-based assay, in vivo bioassay, ELISA)

Verification and validation of bio-analytical methods

Analytical transfer

Troubleshooting activities / Root-cause analysis

Methods improvement

Data-driven mindset

Critical thinking, troubleshooting and problem-solving skills.

Engagement & accountability towards the defined purpose

Function efficiently & independently in dynamic environment

Strong team player and communication skills required with an ability to interact with individuals and teams at all levels across the organization and the global network.

Strong working knowledge of statistics will be highly regarded.

Business travel to other Ferring sites up to 30%.

Location : The position will be based in Kiel, Germany.

People come first at Ferring

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.

Behind our purpose… There’s you

Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.

Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.

We are proud to be an Affirmative Action / Equal Opportunity Employer (including Disability / Protected Veterans). We maintain a drug-free workplace.

Location :

Ferring Germany Production