Senior Scientist, Downstream Bioprocess Drug Substance and Commercialization ( MERCUSR187816ENUS)
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 the Manufacturing Division, the Bioprocess Drug Substance and Commercialization (BDSC) department provides technical process leadership and laboratory capabilities in support of late stage pipeline and commercial manufacturing processes for large molecule products, including biologic and vaccines. Within BDSC Bioprocess Engineering, we partner across areas of our Company Manufacturing Division and cross-divisionally with our Research & Development Division with the ultimate goal of delivering innovative products to patients.
The primary responsibility of the engineers and scientists within the Bioprocess Engineering group is to deliver Stage 2 validation requirements for novel, pipeline products to the intended commercial manufacturing sites. BDSC Process Engineering supports various commercialization activities, including technology transfer to internal and external manufacturing sites, process validation, authoring of regulatory submissions, manufacturing investigations and trend evaluations, process enhancements, and next generation process (i.e., post approval) characterization. Through process engineering, we ensure that our company’s large molecule drug substance processes can be scaled up or scaled out into the manufacturing facilities with our respective partners.
This person will support late stage and commercial downstream technology transfer, large scale process optimization, characterization, and validation of purification processes for multiple indications. This person will demonstrate scientific, experimental, and tech transfer skills focusing on downstream processing.
- Participates in and/or leads project team focusing on late-stage clinical process characterization, technology transfer and validation of biopharmaceutical molecules with line-of-sight for licensure and commercialization.
- Participates and/or drives optimization of scalable, efficient, high-yielding, high-purity, and cost-effective downstream purification processes.
- Participate and/or recommend technical innovations for the continuous improvement of platform technologies for recovery and purification of novel therapeutic programs
- Establish and implement appropriate strategies for stage 2 process validation, including strategies for mixing, resin/membrane reuse, and hold time studies.
- Responsible for planning or executing scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally. Leads design of experiments, data analysis, interpretation and authoring of documents.
- Provides technical leadership in the interpretations of trends observed in commercial 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.
- Focus will be on downstream processing, but to have a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, analytical, and drug product.
- Position will interact with and influence various functions across late-stage development and commercialization (i.e. process development, analytical, quality, technical operations, external manufacturing, regulatory, value chain management).
- Supports or authors required regulatory and technical documentation associated with process Tech Transfer, PPQ, and validation. Ensures that process/product are developed and documented according to standard company practices. Supports regulatory queries and inspections as required.
Education Minimum Requirement:
- B.S. in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 6 years relevant knowledge OR M.S. in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 4 years relevant knowledge. PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry candidates with 0+ year(s) of relevant knowledge will also be considered.
Required Expertise and Skills:
- Technical knowledge in purification of biopharmaceutical molecules, including laboratory models for chromatography and filtration systems. Experience with downstream purification of biopharmaceutical molecules required, with an in-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.
- Expertise with technology transfer and/or scale-up of processes to pilot and manufacturing scales for biopharmaceutical manufacture.
Preferred Expertise and Skills:
- Working knowledge of the requirements associated with site readiness for new product introductions, and ability to oversee teams through these requirements. Should have familiarity with GMP principles and regulations
- Expertise with site operations and commercial scale equipment.
- Technical operations expertise in the manufacture of biopharmaceutical molecules at the pilot- and/or commercial-scale is a plus.
- Prior expertise 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 biopharmaceutical processes.
- Working understanding of analytical methods to characterize biopharmaceutical processes and /or US/EU regulatory requirements and / or working knowledge of cGMPs is a plus
- Excellent oral and written communication skills. Ability to effectively articulate understanding of process science to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
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 …
We are known as Merck & Co., Inc., Rahway, 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 …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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