Work unit process developer who supports and contributes to the development of novel/new biotherapeutics via approved standard operating procedures (SOPs) and product validation for FDA-regulated, cGMP compliant manufacturing operations under the intellectual and scientific guidance of process development director, scientists, and managers.
Responsible for improvement of existing methods or implementation of novel technology of proven validity within the work unit. Analyze, organize, and present data in clear, concise manner. Creates batch record documentation, maintains laboratory notebooks and prepares protocols and reports in a compliant manner.

Additional Information:

Work unit process developer who supports and contributes to the development of novel/new biotherapeutics via approved standard operating procedures (SOPs) and product validation for FDA-regulated, cGMP compliant manufacturing operations under the intellectual and scientific guidance of process development director, scientists, and managers. Responsible for improvement of existing methods or implementation of novel technology of proven validity within the work unit. Analyze, organize, and present data in clear, concise manner. Creates batch record documentation, maintains laboratory notebooks and prepares protocols and reports in a compliant manner.

*This position does not support visa sponsorship

Bachelor's degree in biotechnology, biological science, chemistry, immunology, cell/molecular biology, bioengineering or other related science from an accredited institution with 5+ (Bachelor’s) years of related process development or laboratory experience within the biologics industry. Master's degree from an accredited institution in chemical, physical, biological, immunological, cell/molecular or bioengineering preferred. Self-motivated, highly organized, efficient, and able to work under minimal supervision, exercising strong decision-making skills. Excellent written and verbal communication skills are necessary. Capable of reproducing a reference method using available procedures with minimal supervision. Demonstrated analytical and scientific competency with process development and/or validation of lab techniques or procedures. Experience with data collection, organization, analysis and delivery of information.