Senior Specialist, MTS

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.  

The Senior Specialist, MTS is accountable for functional, technical, and business objectives and supports project execution for drug product technology transfer, continuous improvement, and regulatory compliance at the US Production site (Ferring Production, Inc.).

In this role, the Senior Specialist develops and improves processes to meet business needs, manages complex issues within their area of expertise, and contributes to project delivery while ensuring compliance. They also maintain and expand the CPV program and collaborate with Quality Control to assess and enhance analytical methods for cell and gene therapy drug products.

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. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country. 

Responsibilities:  

•  Maintain and expand CPV Program, including gathering and review of CPV data, providing statistical analysis of equipment and process related data, generation of CPV plans, investigating process related OOTs, and supporting analytical method investigations.

• Accountable for functional and technical objectives to support aseptic fill/finish drug product manufacturing including process/analytical method improvements/optimizations, process and analytical technology transfer.

• Author and review technical documents including, but not limited to technology transfer studies, engineering studies, FMEA, CPV, and associated protocols/reports.

• Execute technical/engineering studies related to design of experiment (DOE) studies for process/analytical method understanding, process development studies, and process validation to ensure robustness and quality of drug products.

• Contribute to the authoring of common technical documents for Chemistry, Manufacturing and Controls and associated modules.

• Initiate, track and resolve Production/Packaging related non-conformance investigations. Assist area management in the investigation of the root causes, recommend corrective action(s).

• Support URS development and the execution of FAT, SAT, and IOPQ as required for new equipment

• Support the continuous improvement initiatives through the Lean Six Sigma (LSS) program.

Requirements: 

• Bachelor’s degree in biology, biotechnology, chemical engineering, or a related scientific discipline required.

• Master’s degree in a related field preferred.

• 3+ years of relevant experience in biopharmaceutical, pharmaceutical, biotechnology, or laboratory research environments.

• Laboratory or manufacturing experience with biological, pharmaceutical, or gene/cell therapy products

• Experience supporting process development, analytical method development, or process monitoring

• Knowledge of aseptic techniques, sterile processing, or controlled environments

• Experience with statistical analysis, data trending, or design of experiments (DOE)

• Familiarity with GMP or other regulated laboratory environments preferred.

• Experience documenting experimental procedures, preparing technical reports, or maintaining laboratory documentation.

• Strong problem-solving, analytical thinking, and troubleshooting abilities

• Experience analyzing process or experimental data

• Ability to interpret and summarize scientific or technical information

• Ability to work cross-functionally with manufacturing, quality, research, and technical teams

• Strong written and verbal communication skills

• Experience with process validation, technology transfer, or statis