Merck Associate Principle Scientist - Surface Plasmon Resonance in North Wales, Pennsylvania
The Biologics and Vaccines Analytics (BVA) department within our Manufacturing Division is seeking a talented and self-motivated scientist with solid experience in maintaining and advancing a Surface Plasmon Resonance (SPR) testing program, in order to advance SPR development and testing for large molecule (biologics) products; partner with our Company's Research Laboratories to guide the development and transfer of methods into our Manufacturing Division; develop strategies and perform method qualifications within our Manufacturing Division to demonstrate fit for purpose method qualification, and provide technical support for products during late stage development and throughout the commercial product lifecycle.
The successful candidate will have experience in method development, qualification and/or testing of biologic products and be familiar with current industry and regulatory thought and innovative approaches to utilization of surface plasmon resonance methods to control product quality throughout the product commercial lifecycle.
Position Qualifications :
Education Minimum Requirement:
Ph.D. degree with 3 year relevant working experience
Master degree with 6 years relevant working experience
Bachelor degree with 10 years relevant working experience
Required Experience and Skills:
Hands-on experience in Surface Plasmon Resonance method development, validation and troubleshooting for protein biologics
Prior experience in analytical technology transfer and day-to-day management and oversight of laboratories performing release, stability or characterization testing of biologic or vaccine products
Ability to design experiments; interpret, discuss and present results
Strong knowledge of current global regulatory thought related to all aspects of Surface Plasmon Resonance Technology
Experience in use of common electronic laboratory systems and software, including Empower, LIMS, electronic laboratory notebook
Knowledge in troubleshooting and maintenance of common UPLC, HPLC and CE platforms
Excellent organizational skills to manage multiple projects
Good written and oral communication skills
Ability to work and lead in a collaborative multidisciplinary working environment.
Preferred Experience and Skills:
Experience in biologic and/or vaccine drug product manufacturing, process development and release testing
Experience in day-to-day management of laboratory analysts performing method development, validation, release and stability testing
Familiarity with additional or emerging/innovative SPR technologies
Training and proficiency in current good manufacturing practices
Successful track record of interactions of a biologics or vaccines quality control or analytical development laboratory
Experience in authoring of regulatory documentation and health authority interactions representing analytical function
Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
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 .
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Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R102280
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