OFFICIAL JOB APPLICATIONS MUST BE SUBMITTED TO THE MERCK JOB SITE AT www.merck.com
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Externalization team within the Early Formulation and Externalization (EFEx) group is focused on executing the Pharmaceutical Sciences sourcing strategy across all phases of small and large molecule R&D development operations. The Senior Specialist will serve as a bridge between our organization’s Pharmaceutical Sciences product development teams, internal partner groups (quality, analytical, procurement, and global clinical supply) and external service providers to execute drug product batch manufacturing campaigns development and current good manufacturing practice (cGMP). Projects may include solid oral dosage forms (tablets, capsules, modified release formulations), sterile products, or specialty dosage forms. They will also design and implement strategies to realize new manufacturing technologies and dosage forms in the external network. The candidate will have opportunities to improve business practices and work with project teams on the technical aspects of products in development.
Project management and execution of external development and cGMP manufacturing activities
Provide manufacturing and compliance expertise to project teams
Support Pharmaceutical Sciences technology development efforts by sourcing external services such as equipment trials, research collaborations, software trials, etc.
Identify and champion continuous improvement projects for the workflows within the group
Education Minimum Requirement:
Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline.
Required Experience and Skills:
3 years pharmaceutical industry experience in drug product development or manufacturing.
Detailed knowledge of cGMP requirements for drug product manufacturing
Direct experience of working with wide range of external suppliers inc. contract manufacturing organizations
Preferred Experience and Skills:
Experience with development and/or manufacturing of sterile drug products
Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate
Effective management of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure
Ability to sustain high levels of performance in a constantly changing environment
Proven time management skills and ability to be flexible to meet job demands and take on new initiatives and improvement efforts
Internal Number: PRO018369
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