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Associate Principal Scientist, Biologics Upstream Process Development

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

Our Development team ensure production can be scaled up whilst remaining stable, effective, deliverable and safe. Following formulation, cutting edge computer modelling techniques are used to simulate outcomes and, if successful, PKPD and toxicity studies bring the science one step closer to giving hope to patients.

The Biologics Process Research & Development organization within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics, and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new manufacturing technologies. We work with our partners in our company's Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and energetic individual to join our Upstream Process Development Department as Associate Principal Scientist.  Applicant must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities. Evidence of strong cross-functional collaboration, leading projects, and strong external presence through scientific excellence, and capacity for team leadership and mentoring junior staff are expected.

In this role, the successful candidate will work closely with highly motivated team of Scientists and Engineers in the Upstream Process Development Department and contribute to CMC development of our company's pipeline, playing an active role in design, development and optimization of cell culture processes and transfer processes to clinical and commercial manufacturing sites. She/He will also participate to developing and refining strategies related to next generation processes through technology development initiatives for assets in early and late stage clinical development. 

Responsibilities include, but not limited to:

  • Participates in and/or leads upstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable cell culture processes.
  • Responsible for process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs an BLAs for the company's pipeline.
  • Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies.
  • Advancing the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs.
  • Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies.
  • Keep up to date with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies.

EDUCATION REQUIREMENTS: 

  • Ph.D. or Master’s in chemical engineering, Bioengineering, Biological Engineering, or a related field with 4+ years (for Ph.D.) or 8+ years (for Masters) of industry experience.

REQUIRED SKILLS:

  • Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins.
  • Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems.
  • Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.).
  • Understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors and bioreactor scale-up principles from laboratory to large scale.
  • Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
  • Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
  • Plan, execute, analyze, and communicate complex and critical data in a highly organized manner.
  • Excellent verbal, written communication, and interpersonal skills.
  • Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors.
  • Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
  • Productivity and efficiency working in the laboratory.
  • Ability to deliver complex objective under aggressive timelines.

PREFERRED SKILLS:

  • Experience with cell culture media development.
  • Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.
  • Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.
  • Background in data science approaches related to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts).
  • Experience with late stage commercial process development, technology transfer, scale-down model qualification and process characterization.
  • Knowledge of biologics CMC development cycle and scale-up/down, tech transfer to GMP manufacturing site.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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.

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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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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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.

Search Firm Representatives Please Read Carefully 
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:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R139385

Associate Principal Scientist, Biologics Upstream Process Development

Kenilworth, NJ
Full Time

Published on 12/31/2021

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