Senior Scientist, Downstream, Biologics Process Development and Commercialization

Job Description

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 Manufacturing Division, within the Manufacturing System Design & Commercialization organization, the Biologics Process Development & Commercialization department provides the technical process leadership and laboratory capabilities in support of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). For pipeline programs, the department supports various commercialization activities, including technology transfer to internal and external manufacturing sites, process characterization, process validation, and authoring of regulatory submissions. For commercial programs the scope includes manufacturing investigations and trend evaluations, process enhancements, next generation process (i.e., post approval) development and process characterization, process validation, and regulatory submission authoring.

As part of the Downstream Process Sciences group, this person will be part of a team of scientists and engineers promoting late stage and commercial biologics programs with a focus on downstream processes and laboratory capabilities. We are seeking an energetic colleague with strong partnership and communication skills, who will demonstrate scientific and experimental abilities focusing on downstream processing of biologics.

Technical Scope

• Driving scientific advancements and rigor within teams focusing on late stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.

• Accountable for laboratory-scale downstream/purification studies to promote commercial process definition and characterization (development of control strategy), and investigation evaluations, including studies performed either in-house or externally. Provides technical influence for the design of experiments, data analysis and interpretation.

• Provides technical direction in the interpretations of trends observed in 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 downstream process sciences and experimentally based work packages, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including upstream processing, analytical, and tech transfer.

• Actively interacts with internal and external counterparts. May represent functional area on cross-functional and cross-divisional teams.

• Authors regulatory and technical documentation. Ensures that process/product are developed and documented according to standard our Company practices.

Education Minimum:

BS or MS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 6 years (for BS) or 4 years (for MS) relevant knowledge. PhD candidates with 0+ year(s) of relevant knowledge will also be considered.

Knowledge and Skills:

• Technical background in protein biochemistry, and in purification of biological molecules, including laboratory models for chromatography and/or filtration systems.

• Excellent oral and written communication skills. Good working knowledge of general office software (e.g., Microsoft Word, Powerpoint, etc)

Preferred Knowledge and Skills:

• Biological molecules in a laboratory setting is desired.

• Technical operations knowledge in the manufacture of biological molecules at the pilot- and/or commercial-scale is a plus.

• Practical industry knowledge in biologics process development, manufacturing batch record reviews and/or operations, authoring regulatory BLA sections are all advantages for this role.

• Working knowledge of statistics (e.g., statistical process control (SPC), multivariate analysis (MVA), or Design of Experiments (DoE)) including use of software such as JMP or Design Expert is a plus

• Working knowledge of analytical methods to characterize biologics is a plus

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., 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.

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.

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R135064