Bioanalytical Expert

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

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.

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

The position will be in one of the following locations: Parsippany/Ocean Township, NJ, USA; Copenhagen, Denmark; France; Italy; Germany.

You will be surrounded by highly skilled and dedicated colleagues, including various experts that you will collaborate with as part of your activities.

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 cell-based content, 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, etc.

With your expertise in biological assays, your activities will include (but are not limited to):

- 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

To be successful in this role, you should have the following competencies:

- Master of Science or equivalent, in a relevant field such as cellular biology, virology, immunology.
- A minimum of 7 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.
- Willingness to travel for up to 40%.

People come first at Ferring
- Get inspired from our commitment to advocate for everyone’s right to build a family, no matter who you are, where you live or who you love
- Our inclusive support package - “Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role. Available to all employees after the first year of employment.
- Parental leave for both birthing and non-birthing parents
- Extended support on family building journey

Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expert