Senior Principal Scientist, Downstream Biologics Process Development

Job Description

Our Scientists are our Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science, and technology, we collaborate to deliver the next medical breakthroughs. We are looking for a collaborative, self-motivated  scientific leader with expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.

BPR&D within our company's Research Laboratories (is committed to rapidly delivering diverse biotherapeutics to patients by efficiently developing innovative and robust manufacturing processes and technologies. To achieve our goals, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a diverse and inclusive environment. In addition to process development for pipeline biologics, we are focused on innovating and building next-generation biomanufacturing technologies. This includes 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 a Senior Principal Scientist, you will drive various strategic initiatives and translate strategies into  implementation for our company's Downstream Processing of Biologics. You will collaborate with a creative and dedicated team of scientists and engineers to design purification processes while developing and applying  strategies related to downstream processing for drug candidates in both early and late-stage development.

Responsibilities include, but are not limited to:

• Serve as a scientific leader to shape and drive innovation across the Biologics pipeline, strategy, and science.

• Anticipate and solve scientific and technical challenges across projects and functional teams, in a fast-paced, multidisciplinary environment.

• Lead the development of robust and scalable purification processes for biologics in various stages of clinical development, as well as process characterization and regulatory filings for successful commercialization.

• Improve downstream processes by increasing efficiency and cost-effectiveness through research and innovation, while evaluating technologies and industry best practices.

• Collaborate with academia, industry, and vendors to facilitate the development and early adoption of novel process technologies.

• Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.

• Conceptualize, plan, and execute projects using effective organizational, prioritization, and problem-solving skills.

• Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through conference participation.

• Represent BPR&D as a downstream bioprocess expert/co-leader in internal and cross-functional project teams.

• Supervise, coach, and develop talent within the functional area; guide career development; build strong, collaborative teams.

• Champion compliance and safety while promoting a culture of diversity, equity, and inclusion.

Minimum Education Requirements:

• Ph.D. with 10+ years, MS with 12+ years, or BS with 14+ years of industry experience in Chemical/Biochemical Engineering or a related field.

Required Experience, Skills, and Competencies:

• In-depth knowledge and expertise in downstream processing of biologics, biologics CMC development, and the associated challenges.

• Extensive experience in conducting and directing the design, execution, analysis, and documentation of purification process development.

• Proven track record of accomplishments in downstream bioprocessing, including peer-reviewed publications and presentations.

• Ability to adapt to and prioritize complex objectives under tight timelines in a rapidly changing environment.

• Experience leading internal and external cross-functional, matrixed teams.

• Demonstrated scientific leadership with significant, measurable project impacts across a diverse set of programs.

• Action-oriented mindset with a capacity for creativity; ability to take initiative, innovate, iterate, and solve problems.

• Supervise and coach scientists to maximize talent development and utilization.

• Excellent interpersonal and communication skills.

Preferred Experience & Skills:

• Leadership of CMC development teams.

• Experience with continuous biomanufacturing integrated with process-analytical technologies.