- Doctoral Degree
- Bachelor's Degree
- Master's Degree
- High-Performance Liquid Chromatography
- Communication Skills
- System Design
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
As part of our Company Manufacturing Division within Manufacturing Systems Design and Commercialization (MSDC), the Biologics Process Development and Commercialization (BPDC) department provides the technical process leadership and laboratory capabilities in support of late stage pipeline and commercial drug substance manufacturing processes for biologics (therapeutic proteins). For pipeline programs, BPDC supports various commercialization activities, including technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, the scope includes site-to-site process transfers, manufacturing investigation and trend evaluations, process enhancements, next generation process (i.e., post approval) development and characterization, process validation, and regulatory submission authoring.
Reporting to an Associate Principal Scientist in Downstream and Process Analytics, this individual will support late stage and commercial biologics programs with a focus on in-process analytics and characterization testing. The individual will demonstrate a scientific understanding of the product and the process sciences, and will develop broad, experience-based skillsets in analytical methods common for biologics required for the scope of BPDC activities.
Primary focus will be in-process analytics, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, purification, and site readiness. (As part of the broader Downstream and Process Analytics group, may also have some scope in downstream process work.)
Provides technical leadership for method development and qualification, as well as the execution of (internal) or management of (external) laboratory activities. Responsible for in-process characterization testing of laboratory-scale and manufacturing-scale studies to support commercial process validation, characterization, and investigation evaluations.
Leads process and product comparability assessments to support facility and process changes during late stage development or in-line product support.
Builds and establishes internal and external networks to identify solutions to technical and business problems. Represents functional area on cross-functional and cross-divisional teams.
Authors and reviews required regulatory and technical documentation.
Education Minimum Requirement:
BS, MS or PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 6 years (for BS), 4 years (for MS), or 0 years (PhD) relevant experience.
Required Experience and Skills:
In-depth technical knowledge and expertise in the characterization of biological molecules.
Experience with HPLC and/or UPLC method development and qualification.
Excellent oral and written communication skills. Demonstrated ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.
Preferred Experience and Skills:
Working knowledge of mass spectrometry.
Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software), statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes
Working understanding of US/EU regulatory requirements and working knowledge of cGMPs.
Demonstrated experience in lean leadership/operational excellence with applicability to functional area (e.g. labs) or manufacturing processes.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
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.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
If you need an accommodation for the application process please email us at email@example.com