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Associate Principal Scientist, Upstream Process Development

Merck Cherokee

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Kenilworth, NJ
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Job Description

As posted by the hiring company

Job Overview:

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Attention NJ Applicants: In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, the NJ work location for this role will be temporarily based and the exact timing of the departmental move to Rahway, NJ will be communicated at a future date.

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 Development Department in a lab-based role as an Associate Principal Scientist. Applicant must have effective organizational and multi-tasking skills, demonstrated excellent technical leadership, and superior written and oral communications abilities. Evidence of strong cross-functional collaboration, leading projects, and external presence, including capacity for team leadership and mentoring junior staff, are expected.

In this role, the successful candidate will work closely with other Scientists in the Upstream Process Development Department and contribute to CMC development of our company's pipeline, playing an active role in development of cell culture processes and transfer to clinical and commercial manufacturing sites. They will also participate to develop and refine strategies related to next generation processing for assets in early- and late-stage clinical development.

Primary Responsibilities:

  • 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 and 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

  • Advance 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; Present and publish externally and pursues patenting strategies

Education Requirements:

  • Ph.D. or Master’s in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with 3+ years (for Ph.D.), 6+ years (for Masters) of industry experience, 8+ years (Bachelors)

Required Experience and Skills:

  • Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins

  • 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.

  • 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

Preferred Experience and 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

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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:

10%

Flexible Work Arrangements:

Not Specified

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

2