Title:  Process Development Scientist I

Job Summary

Provides support for new product formulation, aseptic & topical process development, process transfers and troubleshooting existing manufacturing processes.

Area Of Responsibility

• Work with production to support the transfer of manufacturing processes
• Provide support for new product formulation and process development, including lyophilization development and process transfer into manufacturing
• Execute laboratory experiments
• Assist with investigations of established manufacturing procedures
• Draft scientific experimental plans and protocols, execute and document experiments
• Perform data analysis, prepare reports and other documents as needed
• Provide investigational support of established manufacturing procedures
• Prepare protocols, SOPs, technical reports and other cGMP documents
• Work under supervision using standard and safe laboratory practices and procedures
• Work with external contractors to obtain new equipment, technology or solutions for experimental plans
• Other duties as assigned

Work Conditions:

• Laboratory, fume hood, warehouse and office areas
• Exposure to noise, hazardous and nonhazardous chemicals and waste
• Must wear protective clothing in lab - lab coat, safety glasses and gloves

Physical Requirements:

• Periodic use of repetitive motion
• Stand, sit, use hands and fingers to handle or feel, reach with hands and arms, talk, and hear
• Close and color vision; depth perception, ability to adjust focus
• Lift up to 10 lbs.

Travel Estimate

Up to 5%

Education and Job Qualification

• BS in related scientific major
• Ability to write technical reports to document outcomes of experimental plans
• Ability to work independently and as a member of a cross functional team
• Attention to detail and ability to manage multiple assignments concurrently

Experience

• Minimum 1-3 years related experience preferably in a pharmaceutical / biotech industry
• Experience with techniques such as chromatography, lyophilization, formulation, sterile filtration, and process validation
• Practical knowledge of chemical engineering principles, quality by design, and project management
• Experience with aseptic techniques in a clean room environment
• Experience working in a cGMP environment
• Excellent verbal, written and interpersonal communications skills
• Working knowledge of online collaboration tools, such as Sharepoint, Google Workspace, etc.

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).