Director, Downstream Biologics Process Engineering

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.

For pipeline programs, BPDC Process Engineering 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 sponsorship of site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, 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 commercial manufacturing facilities with our respective partners.

Under the general scientific and administrative direction of the Director, Process Engineering and working in conjunction with internal and external partners, this person will promote late stage and commercial biologics program activities within BPDC. This peer will demonstrate technical and team direction skills with a focus on downstream processing and tech transfer.

Additional Assignments:

• Manages a team with remit for technology transfer of downstream manufacturing processes for biologics into internal and external commercial facilities

• Directs and/or participates on drug substance working group teams and other cross-functional teams with oversight of various aspects of late stage clinical process characterization, technology transfer and validation with line-of-sight for licensure and commercialization

• Provides technical influence on the team to resolve investigations and manage PPQ related deliverables at receiving sites in partnership with partner groups (e.g. Quality, Regulatory, Site Operations)

• Oversee the team’s efforts to develop regulatory content for biologics unit operations for new products. Author, review, and approve documents associated with team’s deliverables for tech transfer, PPQ, validation, and regulatory submissions (e.g. protocols and reports)

• Provides technical direction in the interpretations of trends observed in commercial process manufacturing and identification of process changes that seek to drive improvements to productivity and/or robustness

• Primary focus will be on downstream processing, but with a working knowledge of the end-to-end processes and functional interdependencies to manufacture and introduce new biologics products, including upstream, diagnostic, site readiness

• Actively interacts with internal and external counterparts to identify and use best practices | May represent functional area on cross-functional and cross-divisional teams

• Ensures that process/product are developed and documented according to standard company practices

Education:

• BS or MS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 14 years (for BS) or 12 years (for MS) relevant knowledge. PhD candidates with 8+ year (s) of relevant knowledge will also be considered.

Knowledge and Skills:

• Technical background in purification of biological molecules, including scale-down models and full-scale setups for chromatography and filtration systems

• Technology transfer and scale-up of biologics processes to pilot and manufacturing scales

• Coaching and mentoring a team of scientists and engineers to deliver on peer, group, and departmental objectives

• Ethical verbal and written communication skills | Ability to effectively articulate comprehension of issues to drive result making in a multi-disciplinary team environment

Preferred

• Direct line management

• Demonstrated knowledge of the fundamentals and/or modeling of unit operations is a plus

• Late stage process development, process performance qualification and validation, site readiness, pre-approval inspections, batch record reviews, authoring regulatory sections and/or working with external contract organization for development and or manufacturing of biologics

• Working appreciation of diagnostic methods to characterize biologics and/or US/EU regulatory standards and/or working knowledge of cGMPs is a plus

• In-depth knowledge of preparative chromatography, tangential flow filtration, virus retaining filtration, and viral clearance desired

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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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.

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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:R133134