Biologicals Subject Matter Expert(m/w/x)

# Biologicals Subject Matter Expert (m/f/d) **Kiel, Germany** | **Full time** ## Job Description: At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world. Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging and rewarding careers – we are motivated to make a difference. To reach our full potential we collaborate, and respect and value diverse contributions so that we can grow as an organization and as professionals. Together we can influence the world around us to make life and work better. **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. The position will be based at Ferring GmbH in Kiel, Germany, with business travel to other Ferring sites up to 30%. You will be surrounded by highly skilled and dedicated colleagues, including various experts that you will collaborate with as part of your activities. As a Biologicals Subject Matter Expert (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, robustness). **Your day at Ferring** 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. It is a permanent full-time position. The **preferred base** for this role is **Germany (Kiel)**. **Your contribution to make a difference.** * 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 and be accountable 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. **Your qualifications that enrich us.** * Master’s degree (or equivalent) in a relevant scientific discipline such as Cellular Biology, Virology, or Immunology. * At least 5 years of hands-on experience in biological analytical methods for biologics and large molecules, with strong technical expertise in techniques such as cell-based assays, ELISA, viral titration, and other potency and identity assays. * Minimum of 3 years’ experience in the pharmaceutical industry operating under cGMP regulations, ICH guidelines, and pharmacopoeia standards. * Function efficiently & independently in a 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 but is not mandatory. **People come first at Ferring.** * Make your own contribution to **helping people worldwide**. * Communicate on equal terms through **flat hierarchies** and be a full member of the Ferring family. * At Ferring, you have various opportunities for **individual career planning and personal development** in an internationally operating and innovative environment (e.g., strengths-based coaching). * **Balance your work and private life** through: attractive working time models (with shift and on-call duty allowances based on participation) with the possibility of overtime compensation, part-time work, remote work for positions where it’s possible according to operational needs, as well as 30 days of vacation per year for full-time employees. * **Your performance pays off**: receive an attractive, performance-oriented compensation for your commitment in both the collective bargaining area (based on the IG BCE collective agreement, Chemical Tariff Agreement of Schleswig-Holstein) as well as in the non-tariff area, along with very good annual benefits (Christmas and vacation pay, and an attractive bonus model). * The pme Family Service offers practical advice and support to help balance private and professional life. * **Building Families at Ferring (BFF):** Family and family planning are a heartfelt issue for Ferring, so we support our employees on their own path to starting a family, depending on the type of employment. * **Benefit from Ferring's pension concept**: This includes, depending on whether you have a fixed-term or permanent contract, capital-forming benefits, company pension schemes, and time-value accounts. * A **safety mindset** is crucial at Ferring. We focus on workplace safety but also health: ergonomic advice, height-adjustable desks, workplace inspections, and various health promotion offerings (e.g., Hansefit). * **Transportation support**: Do you commute by bike, bus, train, or car? We offer covered bike storage, subsidies for public transport, and free parking spaces. * Free hot and cold beverages and fresh fruit are a given, but we still want to mention it. * **Corporate Benefits:** Benefit from attractive offers from various companies. * Become part of the Ferring family – surrounded by employees with the same mission. **Behind our purpose... There’s you.** ## Location: Ferring Germany Production