Senior Scientist, Engineering
Our Company Manufacturing Division is a team of dedicated, energetic individuals who are committed to be the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
As part of the Our Company Manufacturing Division, within Manufacturing Systems Design and Commercialization (MSDC), the Biologics Process Development and Commercialization (BPDC) department provides the technical process management and laboratory capabilities in sponsor of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). For pipeline programs, BPDC promotes 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 investigations and trend evaluations, process enhancements, next generation process (i.e., post approval) development and characterization, process validation, and regulatory submission authoring.
Under the general scientific and administrative direction of the Director of BPDC Upstream Process Development and Commercialization, and working in conjunction with internal and external partners, this colleague will sponsor late stage bulk process development, characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to therapeutic proteins. The person will demonstrate scientific, experimental and tech transfer skills focused on cell culture processes.
Contributes to commercialization activities of late stage pipeline and /or commercial manufacturing sponsor for biologics (therapeutic proteins) | Late stage pipeline commercialization, activities include technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions | Commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring
Technical direction on design, planning, and executing laboratory experiments and investigations for the purposes of generating new data and knowledge | Authors experimental protocols and documents work in a lab notebook. Documents lab activities, findings, and conclusions in scientific reports, and presents knowledge at appropriate forums | Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations
Managing large multifaceted projects as the principal of a cross-functional team | principal contributor, may be concerned with clearly identifiable elements or functions within a larger project team | Oversee and coordinate work performed by contractors
Systematically and scientifically conducting cell cultures experiments for process development activities and comprehension/troubleshooting manufacturing deviations and raw material assessment
Train junior staff for operations in laboratory-scale and pilot-scale bioreactors
Contribute to a safe and compliant laboratory work environment
Working outside of core business hours to promote lab studies and/or on-site activities related to tech transfer and manufacturing
GMP tasks include authoring, reviewing and approving technical and regulatory documents
B.S. in Chemical Engineering or Biochemical Engineering or related field with a minimum six years of relevant knowledge; or Master's in Chemical Engineering or Biochemical Engineering or related field with a minimum four years of relevant Knowledge; or Ph.D in Chemical Engineering or Biochemical Engineering or related field with a no minimum relevant knowledge
Knowledge and Skills
Upstream process development and manufacturing sciences knowledge
Scientific comprehension of cell biology and engineering standards for recombinant protein production with mammalian cell culture
Ability to execute studies and experiments in the context of long-term commercialization plans
Cell culture aseptic technique, assays and general laboratory practices
Proven ability to design and execute cell culture experiment objectively from protein expression to different cell culture scales including shaker flasks and bioreactor
Subject Matter Expert on processes such as fed batch and perfusion.
partner with downstream, process analytics, and other functional teams in both R&D and manufacturing to advance biologics inline/pipeline.
Knowledge with statistical data analysis
tools such as design of experiment and multivariate data analysis
Strong passion and investment to integrate science to biologic process development
Ability to foster a combined work environment
Outstanding communication and people skills
High throughput cell culture technique and automation
Perfusion cell culture and cell retention devices such as ATF, TFF, acoustic wave etc.
Bioreactor and/or process control systems such as MFCS and DeltaV
Bioanalytical techniques such as flow cytometry, microscopy, biochemical assays and cell functional assays
Design of Experiments (DOE), and Lean Six Sigma standards
Software and statistical tools (JMP, Spotfire, SIMCA) for data mining, data analysis, modeling and statistical process control (SPC)
Our Manufacturing & Supply Division is dedicated to being 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 …
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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