Process Development Scientist, Advanced in Santa Clara, CA at Volt

Date Posted: 11/17/2020

Job Snapshot

Job Description

Volt is seeking a Process Development Scientist. In this role you will lead process development and scale-up of manufacturing processes production in a lab environment. Designs and develops processes for manufacturing using statistics based experimentation and principles of process excellence. Works with internal organizations and vendors to ensure regulatory and company compliance of manufacturing processes. Involved in new product scale-up, purification, process optimization, technology transfer and process validation activities. Develops production procedures and product specifications. Monitors the performance of processes and equipment and makes recommendations for continuous improvement. Develops custom pilot scale and commercial manufacturing equipment. Works with equipment vendors to define, develop, implement and qualify process equipment.

In this role you will be responsible for the synthesis, isolation, purification, and analysis of synthetic oligonucleotides, and in transferring the knowledge and skills to production personnel.  Key responsibilities will include the preparation and purification of synthetic RNA and chemically modified synthetic RNA using automated solid-phase synthesis techniques. You will be responsible for maintenance, monitoring and qualification of the hardware components used for the synthesis, purification and analysis of the RNA products. You will be expected to help optimize protocols for use in the manufacturing environment. As a Process Development Scientist, the successful candidate will work as a member of a team that develops, validates and documents new manufacturing processes and QC processes, troubleshoots existing processes and analyzes process data in order to identify potential problems and opportunities for improvement.

Determines and develops approaches to assignments

Leads process development projects requiring coordination with other functions, suppliers

Solves a broad range of problems varying in scope and complexity"

Required Qualifications:

- BS/BA or MS/MA or PhD in Chemistry or Biochemistry, or equivalent

- Typically, 4+ years relevant experience for entry to this level.

- Experience with HPLC purification techniques

- Experience with Mass Spectrometry

- Demonstrated track record of successful process development and process troubleshooting

- Practiced in the preparation and bottling of buffers and reagents, as well as the management of laboratory chemicals and raw materials inventories

- Excellent time management, record keeping, attention to detail, teamwork and communication skills

- Computer literacy including proficiency with Word, Excel and PowerPoint

- Requires in-depth knowledge and experience in job and ability to work independently

Desired Qualifications

- 2+ years experience in solid-phase oligonucleotide synthesis, using and trouble-shooting automated solid-phase synthesizers and optimizing synthetic protocols and reaction schemas.

- 2+ years experience in the evaluation, analysis, characterization, purification, and optimization of purification protocols of oligonucleotides (RNA and DNA) via HPLC.

- Hands-on experience manipulating and synthesizing RNA and practiced in anhydrous and RNAse-free lab techniques.

- Experience in an ISO 13485 or FDA regulated environment, familiarity with analytical method qualification and process validation

- Working knowledge of basic statistics and process monitoring

Volt is an Equal Opportunity Employer