Senior Scientist, Process Engineering, Upstream (Remote)

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 guides 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 the assistance of site-to-site process transfers, process enhancements, next generation process (i.e., post approval) development and process characterization, 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 manufacturing facilities with our respective partners.

Under the general scientific and administrative direction of a Principal Scientist, Biologics Process Engineering and working in conjunction with internal and external partners, this person will assist with late stage and commercial biologics program activities within BPDC. This person will demonstrate scientific, experimental and technology transfer skills primarily focusing on upstream processing while collaborating with partners to drive downstream processing, analytical and overall process modeling activities.

Job Skills:

• Serves as a sub-team guide for and participates on cross-functional teams in sponsorship of technology transfer, process validation/PPQ, facility fit, risk assessments, manufacturing campaigns, process and plant modeling, regulatory filings (IND/BLA/PAS) and post approval life cycle management.

• Provides technical influence in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA))

• Provides technical influence for technical investigations and process changes that seek to drive improvements to yieldand/or robustness.

• Partners with laboratory on the design of experiments, data analysis and interpretation of bench/pilot scale studies to assist with technology transfer and process characterization.

• Partners with multiple functions, including the manufacturing site, to establish the commercial process description and integrated control strategy.

• Primary focus will be on drug substance upstream processing, but position requires a working knowledge of the various aspects of product manufacture and functional area interdependencies, including downstream processing, analytical, and site readiness.

• Actively interacts with internal and external counterparts. May represent functional area on cross-functional and cross-divisional teams and directs technical teams through matrix structures.

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

Position Qualifications:

• Education: BS, MS or PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 6+ years for BS, 4+ years for MS, 0+ year(s) for PhD

Skills:

• Cell culture skills to produce biological molecules from mammalian-based expression systems, with an in-depth knowledge of seed expansion, production bioreactor (fed-batch and perfusion mode) and harvest. Demonstrated comprehension of the fundamentals and/or modeling of unit operations.

• Late stage process development, process characterization, technology transfer, facility fit assessments, commercial control strategy, process validation/PPQ, manufacturing site readiness and regulatory submissions (IND, BLA, PAS).

• Ability to effectively articulate appreciation of process engineering to drive results, impact assessments, design of studies, etc., in a multi-disciplinary team environment.

• Excellent oral and written communication skills.

Preferred Skills:

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

• Direct skills with internal and external contract manufacturing organizations.

• Prior skills with PAI, regulatory inspections and working knowledge of cGMPs.

• 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 biologics processes.

• Working comprehension of analytical methods to characterize biologics.

• Application of process and/or economic modeling related to biologics drug substance manufacturing.

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 Our Company & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and Our Company 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.

Residents of Colorado

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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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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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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:

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Number of Openings:

Requisition ID:R117982