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Principal Scientist – Downstream Biologics Process R&D

Principal Scientist – Downstream Biologics Process R&D

CompanyMerck
LocationLinden, NJ, USA
Salary$169700 – $267200
TypeFull-Time
DegreesBachelor’s, Master’s, PhD
Experience LevelSenior, Expert or higher

Requirements

  • Ph.D. with 6+ years, MS with 8+ years, or BS with 10+ years of industry experience and background in Chemical/Biochemical engineering, or a related field
  • Strong fundamental knowledge and subject matter expertise in downstream processing of biologics, recent advances, and challenges in the field
  • Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of purification process development
  • Track record of accomplishments in downstream bioprocessing with a history of peer-reviewed publications and presentations
  • Knowledge of biologics CMC development
  • Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment
  • Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams
  • Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate and problem-solve
  • Demonstrated commitment to coach and mentor staff to maximize talent development and utilization
  • Excellent interpersonal and communication skills

Responsibilities

  • As an impactful contributor, shape and realize innovation across the Biologics’ pipeline, strategy, and science
  • Advance the pipeline by collaborating with cross-functional teams, from Research & Manufacturing, in a fast-paced, multidisciplinary environment
  • Participate in or lead development of robust and scalable purification processes for biologics in different stages of clinical development, process characterization and regulatory filings for successful commercialization
  • Advance downstream processes by improving efficiency and cost effectiveness through research and innovation, while assessing technologies and industry best practices
  • Collaborate with academia, industry, and vendors to drive development and early adoption of novel process technologies
  • Contribute to strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams towards its execution
  • Conceptualize, plan, and execute projects with effective organizational, prioritization and problem-solving skills
  • Stay abreast of scientific and regulatory landscape; actively present (premier conferences), publish (peer-reviewed journals) and patent
  • Represent BPR&D as a downstream bioprocess expert in internal, cross-functional project teams and external conferences/consortia
  • Mentor and actively share expertise; guide career development; build strong, collaborative teams
  • Champion compliance and safety; promote a culture of diversity, inclusion, and equity

Preferred Qualifications

  • Leadership of CMC development teams
  • Continuous biomanufacturing integrated with process-analytical technologies
  • High-throughput experimentation, automation, and process control
  • Knowledge of protein expression, analytics, conjugation chemistry and formulation
  • Biophysical, mechanistic and facility modeling; statistical analysis, data-science, machine learning, artificial intelligence