Director, Engineering | Upstream Process Sciences

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, the Biologics Process Development & Commercialization department provides the technical process influence and laboratory capabilities in promotion of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). For pipeline programs, the department sponsors 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 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.

Reporting to the Executive Director in Upstream, the Director, Engineering | Upstream Process Sciences will direct a team of scientists and engineers promoting late stage and commercial biologics programs with a focus on upstream processes and laboratory capabilities. The person will demonstrate a deep scientific appreciation of the product and the process sciences, and will have broad, skillsets in both large-scale manufacturing sciences and in applicable business processes, including influencing technical direction at our company.

Position Tasks:

• Directs upstream and/or overall drug substance teams focusing on late stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization

• Manages junior staff in the upstream group | Empowers and develops employees to build strong partnership and find patient focused solutions

• Drives division wide initiatives that will enable our company's biologics manufacturing strategic goals, in areas such as supply chain design, advanced/flexible manufacturing formats, and data digitization/democratization

• Provides technical influence for laboratory-scale scale studies to promote commercial process validation, characterization, and deviation/trend investigations, including studies performed either in-house or externally

• 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, logical, health agency and quality system guidelines

• Builds and establishes internal and external networks to identify solutions to technical and business problems | Represents functional area on cross-functional and cross-divisional teams

• Authors and reviews regulatory and technical documentation

Education:

Bachelor or Master of Science or PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with fourteen years (for BS), twelve years (for MS), or eight years (PhD) relevant skill set

Skills:

• Record of biologics drug substance development and commercialization and manufacturing science & technology

• Upstream processing and process control strategies, and working knowledge of downstream & analytics

• Proven ability to drive Innovation

• Strategic and effective verbal and written communication skills | Demonstrated ability to effectively articulate comprehension of process science, to drive result making, impact assessments, design of studies, etc., in a multi-disciplinary team environment

Preferred:

• In-depth knowledge of cell culture, fed batch, perfusion, single use bioreactors, and harvest operations | Demonstrated comprehension of the fundamentals and/or modeling (Omics, CFD) of unit operations is a plus

• Late stage process development, process characterization including microbial/viral control 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 of statistical methods for DOE design, statistical process control (SPC), multivariate analysis(MVA), and/or process analytical technologies

• Working knowledge of (PAT) techniques for biologics processes

• Working realization of logical methods to characterize biologics and /or US/EU regulatory guidelines and / or working knowledge of cGMPs is a plus

• Demonstrated lean direction/operational excellence with applicability to functional area (e.g. labs) or manufacturing processes

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.

#LI-HW2

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.

Invent. Impact. Inspire.

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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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R121045