Associate Principal Scientist, Downstream Biologics Process R&D

$135,500 - $213,400/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Associate Principal Scientist role in the Biologics Process Research & Development organization focuses on developing drug substance manufacturing processes for biologics. This position involves collaboration with various teams to design and optimize downstream purification processes for biological products, ensuring efficient manufacturing for clinical trials and commercial launch.

Responsibilities

• Leading biologic downstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable processes.
• Independently designing and conducting experiments using relevant operational parameters and analytical inputs.
• Providing technical supervision for process development and characterization.
• Collaborating with upstream process development, Biologics Analytical R&D, and other cross-functional teams in both Research and Manufacturing to advance the biologics pipeline.
• Advancing downstream platform process technical strategy and championing creative process improvement initiatives.
• Assessing new technologies, sciences, and industry strategies and their relevance to the company.
• Collaborating with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies.
• Keeping up to date with the external patent and literature environment; actively presenting and publishing externally and pursuing patenting strategies.
• Mentoring junior scientists.

Requirements

• Ph.D. with 3+ years of industry experience or Master with 6+ years industry experience or BS with 8+ years in 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.
• Proven 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 for taking initiative, creativity, and innovation in problem solving.

Nice-to-haves

• Experience with high throughput experimentation using automation platforms such as TECAN.
• Experience using and/or programming process control systems such as DeltaV 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).

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days