Principal Scientist, Upstream Process R&D

Job Description

Job Description:

Our Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities, cutting-edge science, and technology, we partner to deliver the next medical breakthrough. We are seeking a collaborative, self-directed learner with a penchant for problem-solving and expertise in upstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Principal Scientist.

BPR&D within 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.

As a Principal Scientist you will have the opportunity to influence the future direction of Upstream Processing of Biologics. You will work with an immensely creative and collaborative team of scientists and engineers to design upstream, cell-culture processes while developing technical strategies related to upstream processing and recombinant expression of drug candidates in early- and late-stage development.

Responsibilities include but are not limited to:

• 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 upstream processes for biologics in different stages of clinical development, 2) process characterization and regulatory filings for successful commercialization

• Advance upstream 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 an upstream, cell-culture 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

MINIMUM EDUCATION 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

REQUIRED EXPERIENCE, SKILLS, AND COMPETENCIES

• Strong fundamental knowledge and subject matter expertise in cell-culture process development for biologics, fed-batch cell culture, bioreactors across scales, as well as recent advances, and challenges in the field

• Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process development

• Track record of accomplishments in upstream 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

PREFERRED EXPERIENCE & SKILLS:

• Leadership of CMC development teams

• Continuous biomanufacturing and high-throughput microbioreactors integrated with process-analytical technologies

• Intensified inoculum, and perfusion process development

• Expertise in media/solution development and chemistry

• High-throughput experimentation, automation, and process control

• Knowledge of microbial fermentation

• Cell culture and predictive modeling (omics, metabolic flux analysis); statistics, data-science, machine learning, artificial intelligence

#BPRD #PRD

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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