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:

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• Provide technical guidance in the production and analysis of oligonucleotides in a regulated manufacturing environment.
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• 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
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• 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.
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• Utilize change management practices to drive safety, quality, efficiency, and/or cost improvements.
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• Support teams in the transfer of manufacturing processes between manufacturing locations.
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• Responsible for productive cross-site and cross-functional relationships
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• Execution of manufacturing builds when needed to support Development, Pre-Production and Production orders.
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• Able to plan and prioritize assigned tasks and activities with minimal guidance.
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• Execution of tasks independently and with guidance as necessary from project lead or manager.
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• Influences technical decisions in own area of responsibility.
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• Tracks component COGS and associated project expenses
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Requirements:

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

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