Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
We currently have an exciting opportunity for an experienced product development Scientist/Engineer to join Sterile Liquid Commercialization (SLC) supporting sterile/liquid process development. The group is based out of West Point, PA.
SLC is responsible for product development, process scale-up, registration support, and launch support for Merck's sterile drug products. SLC develops formulation and filling processes for sterile pharmaceuticals, vaccines, and biologics programs starting at Phase II and extending through initial years of product launch. SLC also supports life cycle management opportunities and significant process improvements for in-line sterile products.
The person in this role will have the opportunity to:
- Lead product and process development studies for sterile/liquid products.
- Represent SLC on cross-functional project teams and working groups.
- Develop robust and scalable manufacturing processes while minimizing time to launch.
- Implement process improvements to reduce cost structure and enhance robustness
- Oversee preparation of materials for clinical trials and stability studies by collaborating with an internal and external network of pilot plants and manufacturing facilities.
- Lead tech transfer of processes to commercial supply sites
- Support execution of validation lots and contribute to regulatory filing documentation.
- Be recognized as a technical expert and scientific contributor.
- Coach other employees on scientific/technical concepts and assist staff members with the design and execution of lab experiments.
- Lead in creating, sharing, and adopting best practices and business process strategies.
- Travel to global and domestic research and manufacturing sites as required.
- Learn new skills while developing your career in a highly diverse and dynamic organization.
• Bachelor's degree in Pharmaceutics, Chemical Engineering or related-field with a minimum of 8 years of experience; or Master's degree with a minimum of 6 years of experience; or Ph.D. with a minimum of 4 years of relevant experience
• Knowledge of cGMP and typical unit operations for the manufacture of sterile dosage forms.
• Experience in process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
• Prior experience with the development and commercialization of large molecule products (biologics and vaccines) is strongly preferred
• Experience in Design of Experiment (DoE) and statistical data analysis.
• Competency in technical writing.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.Search Firm Representatives Please Read Carefully:
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Visa sponsorship is not available for this position.
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