Associate Principal Scientist, Downstream Process Development

Biologics Process Research & Development – Associate Principal Scientist

The Biologics Process Research & Development organization within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work closely with colleagues in Discovery, Pre‑clinical and Early Development to rapidly develop manufacturing processes for biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and the development and implementation of new manufacturing technologies.

We work with our partners in the company's Manufacturing Division to commercialize and launch new products.

• Lead biologic downstream process development for first‑in‑human and commercial processes, efficiently developing high‑yield, robust and scalable processes.
• Independently design and conduct experiments using relevant operational parameters and analytical inputs.
• Provide technical supervision for process development and characterization.
• Collaborate with upstream process development, Biologics Analytical R&D, and other cross‑functional teams in both Research and Manufacturing to advance the biologics pipeline.
• Advance downstream platform process technical strategy and champion creative process improvement initiatives.
• Assess new technologies, sciences, and industry strategies and their relevance to the company.
• Collaborate with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies.
• Keep up to date with the external patent and literature environment; actively present and publish externally and pursue patenting strategies.
• Mentor junior scientists.

• Ph.D. with 3+ years of industry experience
• Master’s with 6+ years of industry experience
• BS with 8+ years of industry experience in Chemical Engineering, Biochemical Engineering, or a related field

• Proven record of accomplishments in downstream process and technology development with a scientific publication and presentation track record.
• Scientific understanding of the engineering principles for recombinant protein purification unit operations and the ability to design and execute protein purification experiments independently.
• Ability to direct the planning, execution, analysis, and documentation of all stages of downstream process development.
• Ability to work in a matrixed team environment and collaborate with both internal and external partners, including vendors.
• Knowledge of biologics CMC development cycle.
• Demonstrated ability to take initiative, creativity, and innovation in problem solving.

• Experience with high‑throughput experimentation using automation platforms such as TECAN.
• Experience using and/or programming process control systems such as Delta
  
  V and PCS 7.
• Experience with integrated and continuous processing and equipment including multi‑column chromatography systems (BioSMB, PCC, or similar).
• Background or experience in data science approaches related to downstream processes and predictive modeling (multivariate data analysis, machine learning/artificial intelligence, leveraging PAT).

• Medical, dental, vision, and other healthcare benefits for employee and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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