The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Process Engineer role at the Associate Principal Scientist level will serve as a leader in the FLEx sterile GMP facility. As the facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, regulatory certification, as well as other workstreams' critical activities to enable facility startup. This individual is expected to build and develop a team of process engineers and foster a culture of collaboration, learning and innovation. This individual will collaborate closely with the formulators, engineers, Quality reps, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of Merck's pipeline. Once the facility is up and running, this role will support facility operations, formulation and process development activities, quality investigation and change management, author current good practices (GXP) documentation and manage/lead scientists and contractors. The role is based in New Jersey and reports to the Director of the FLEx GMP facility in Pharmaceutical Operations and Clinical Supply.Education Minimum Requirements:
Required Experience and Skills:
- Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 8 years relevant experience
- Master's degree with 6 years of relevant experience, or a
- PhD degree with 3 years of relevant experience.
Preferred Experience and Skills:
- Extensive knowledge and experience of drug product aseptic processing, equipment and sterile technique.
- Experience with Commissioning, Qualification and Validation.
- Experience in leading and supporting quality investigations and change management.
- Familiarity with United States and European Union GMP and Safety compliance regulations.
- Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
- Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
- Experience with quality systems.
- Effective interpersonal and communication skills, both verbal and written.
- Excellent organizational skills to multi-task.
- Desire and willingness to learn, contribute and lead.
- Track-record of independent problem-solving.
- Experience with new sterile GMP facility startup.
- Experience with managing direct reports or matrix teams.
- Knowledge of Investigational drug regulatory requirements.
- Understanding of Clinical Supply Chain Operations.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.Who we are ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives
while Inspiring Your Career Growth
.INVENT.IMPACT.INSPIRE.NOTICE FOR INTERNAL APPLICANTS
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