Principal Scientist, Downstream Process Development

Overview

BPR&D within our Company's Research Laboratories is on a mission to rapidly deliver biotherapeutics to patients by efficiently developing innovative, robust manufacturing processes and technologies. We work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing while providing an inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies, including investments in continuous manufacturing, green and sustainable processes, and proprietary technology platforms.

We actively publish and engage with the scientific community to influence the field.

• 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
  1) development of robust and scalable purification processes for biologics in different stages of clinical development,
  2) 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 at premier conferences, publish in 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 inclusion

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

• 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

Adaptability, Adaptability, Artificial Intelligence (AI), Biomanufacturing, Bioprocess Engineering, Career Development, Cell Culture Process Development, Cell Line Development, Combination Products, Data Analysis, Finite Element Analysis (FEA), Innovation, Innovative Thinking, Leadership Mentoring, Manufacturing Operations, Pharmaceutical Process Development, Prioritization, Process…