Associate Principal Scientist, Biologics Process - Kenilworth, United States - Merck Sharp & Dohme

Mark Lane

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Mark Lane

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Description
Our Research Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we partner to deliver the next medical breakthrough.


BPR&D within Our Research Laboratories is on a mission to rapidly deliver diverse biotherapeutics to patients by efficiently developing innovative, robust manufacturing processes and technologies.

To achieve this, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing while providing a diverse and inclusive environment for all.

Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. Examples include investments for development of continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific community to influence the field.


Responsibilities include, but not limited to:

  • Participate in and/or lead upstream development of first-in-human and commercial processes by efficiently developing high yield, robust and scalable cell culture processes.
  • Responsible for process characterization and regulatory filing activities to ensure a smooth and clear path to successful commercialization.
  • Collaborate with downstream process development, Analytical R&D, and other crossfunctional teams in both Research and Manufacturing to advance biologics pipeline
  • Advance and improve upstream platform processes through creative initiatives that increase operational efficiency and reduce costs.
  • Assess new technologies, and industry strategies that are relevant to our company
  • Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new technologies.
  • Keep up to date with the external patents and literature; actively present and publish externally and pursue patenting strategies.
  • Mentor junior scientists.

MINIMUM EDUCATION REQUIREMENTS:


  • Ph.
D. with 3+ years OR Master's with 6+ years OR B.S. with 8+ years of industry experience and background in chemical engineering, Bioengineering, Biological Engineering, or a related field


REQUIRED EXPERIENCE AND SKILLS:


  • Technical background and handson experience with mammalian cell culture and fedbatch processes to produce recombinant proteins.
  • Scientific understanding and working knowledge of mammalian cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems.
  • Working knowledge of statistical methods (design of experiments, multivariate data analysis) and tools (SIMCA, JMP, etc.).
  • Understanding of cell culture bioreactor performance and principles across scales
  • Track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation history
  • Excellent verbal, written communication, and interpersonal skills.
  • Ability to work effectively in crossfunctional and matrixed team environment; collaborate with both internal and external partners including vendors.
  • Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
  • Capacity for team leadership

PREFERRED EXPERIENCE AND SKILLS:


  • Cell culture media development.
  • High throughput microbioreactor systems and advanced _in situ_ analytics for process monitoring and control.
  • Stateoftheart cell culture processes including intensified inoculuM/Fedbatch and perfusion process development.
  • Data science approaches related to cell culture and predictive modeling e.g., (metabolic flux analysis, omics, machine learning; integration of process analytical technologies).
  • Knowledge of biologics CMC development cycle, scaleup, scaledown model qualification, process characterization, and technology transfer to manufacturing sites.
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.


NOTICE FOR INTERNAL APPLICANTS


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.

BPRD #PRD #EligibleforERP

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with

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