Process Development Engineer 1

This position is intended to support Project Sol activities on the MTO team which may include, but not limited to the following:

Responsibilities:

• Provide technical guidance in the production and analysis of oligonucleotides in a regulated manufacturing environment.
• Collaborate with cross-functional teams to both (1) address operational sustaining needs (i.e. resolve production issues related to safety, yield, quality, and/or throughput) and (2) develop and transfer new processes/products to production and/or to enhance existing processes/products
• Represents and advocates for Operations’ needs in cross-functional meetings to ensure quality, continuity and efficiency of products and processes transferred to and implemented within manufacturing teams.
• Utilize change management practices to drive safety, quality, efficiency, and/or cost improvements.
• Support teams in the transfer of manufacturing processes between manufacturing locations.
• Responsible for productive cross-site and cross-functional relationships
• Execution of manufacturing builds when needed to support Development, Pre-Production and Production orders.
• Able to plan and prioritize assigned tasks and activities with minimal guidance.
• Execution of tasks independently and with guidance as necessary from project lead or manager.
• Influences technical decisions in own area of responsibility.
• Tracks component COGS and associated project expenses

Requirements:

• Manufacturing experience of organic synthesis is highly desirable
• Working knowledge and experience of automated synthesis, preparative and analytical chromatography. LC-MS and ability to interpret NMR is desirable
• Experience in process support and development in a GMP environment
• Strong analytical, problem solving, troubleshooting, and root cause analysis skills
• Strong interpersonal, verbal and written communication skills required
• Must be detail oriented
• Strong understanding of GMP
• Experience with standard laboratory practices
• Experience with SAP or equivalent ERP system
• Experience working in an ISO 13485 or FDA regulated environment is desirable

Education:

• BS/MS degree with 2 years of related experience
• Field of study in Organic Chemistry, Chemistry, Molecular Biology/ Biochemistry, Chemical Engineering, Biochemical Engineering preferred

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.