Senior Scientist, Biologics Process Engineering ( MERCUSR117712ENUS)
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's Manufacturing Division, within Global Vaccines and Biologics Commercialization (GVBC), the Biologics Process Development & Commercialization (BPDC) department provides technical process leadership and laboratory capabilities in support of late stage pipeline and commercial manufacturing processes for biologics. Within BPDC Process Engineering, we partner across areas of our Company's Manufacturing Division and cross-divisionally with our Research & Development Division with the ultimate goal of delivering innovative products to patients.
For pipeline programs, BPDC Process Engineering 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 support of site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process (i.e., post approval) development and process characterization, process validation, and regulatory submission authoring. Through process engineering, we ensure that our company’s biologics processes can be scaled up or scaled out into the manufacturing facilities with our respective partners.
Under the general scientific and administrative direction of the Associate Principal Scientist, Biologics Process Engineering and working in conjunction with internal and external partners, this individual will support late stage and commercial biologics program activities within BPDC. This individual will demonstrate scientific, experimental and technology transfer skills primarily focusing on upstream processing while collaborating with partners to drive downstream processing, analytical and overall process modeling activities.
Participates in teams focusing on late stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.
Responsible for technology transfer and scale-up of drug substance biologics processes to both internal and external manufacturing sites. Provides technical leadership for the design of experiments, data analysis and interpretation of bench/pilot scale studies to support technology transfer and process characterization.
Provides technical leadership in the interpretations of trends observed in drug substance process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
Primary focus will be on upstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including downstream processing, analytical, and site readiness.
Actively interacts with internal and external counterparts. May represent functional area on cross-functional and cross-divisional teams.
Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to standard Company practices.
Education Minimum Requirement:
BS, MS or PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 6 years (for BS), 4 years (for MS), 0+ year(s) (for PhD) of relevant experience.
Required Experience and Skills:
Experience with technology transfer and scale-up of processes to pilot and manufacturing scales for biologics manufacture.
Technical background in cell culture for the production of biological molecules, including bench scale bioreactor laboratory models.
Excellent oral and written communication skills. Ability to effectively articulate understanding of process engineering in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
Preferred Experience and Skills:
Experience with cell culture for the production of biological molecules required, with an in-depth knowledge of seed expansion, production bioreactor (fed-batch and perfusion mode) and harvest. Demonstrated understanding of the fundamentals and/or modeling of unit operations.
Technical operations experience in the manufacture of biological molecules at the pilot- and/or commercial-scale.
Prior experience in late stage process development, process characterization including viral clearance studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.
Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes.
Working understanding of analytical methods to characterize biologics and/or US/EU regulatory requirements and/or working knowledge of cGMPs.
Application of process and/or economic modeling related to biologics drug substance manufacturing.
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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