Scientist, MST

  • Anywhere

Company :
WaVe Life Sciences

Location :
Lexington, Massachusetts

Expiry Date :
Wed, 16 Dec 2020 23:59:59 GMT

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Description :
Scope Job Description * Ensure effective and efficient manufacturing of oligonucleotide product * Provide technical expertise to manufacturing technicians in the manufacturing process * Responsible for maintaining strict quality standards and adhering to cGMP practices throughout the process * Function as interface/liaison between Process Development group and Manufacturing * Collaborate with the Process Development group on scale-up of existing PD processes to manufacturing-ready levels * Responsibilities * May include some or all of the following: * Gives technical support to manufacturing associates in the production of oligonucleotides, including synthesis, purification, desalting and lyophilization * Organize work to ensure efficient utilization of time and materials and to complete all procedures in a cGMP compliant manner * Identifies, understands and resolves technical difficulties * Recognizes and initiates process deviations and non-conformances * Supports continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and helping to implementing those strategies once approved * Respond quickly and effectively to multiple and changing priorities, and to schedule work effectively to ensure that current and future needs are met * Accurately and consistently record methods, materials, and results in batch records according to established formats * Keep manager informed on status of all projects and of significant findings and results in critical areas * Ability to operate and maintain instrumentation * Primary contact from manufacturing to ensure proper process transfers internally and externally (CMOs) * Technical review of batch records and process instructions internally and externally (CMOs) * Participate in meetings to identify and troubleshoot manufacturing issues internally and externally (CMOs) * Participate in on-site visits at CMO from time to time * Give guidance and mentorship to junior team members of the MS&T group * Education_/_Experience * M.S. or Ph.D. degree in chemistry, science or engineering is preferred or equivalent work experience * 2+ years bio-pharma manufacturing industry experience in a cGMP environment * Oligonucleotide manufacturing experience * Experience w/ AKTA platform preferred * Hands-on experience w/ preparative HPLC pref d * Skills_/_Pre-requisites * Familiarity with and ability to work under cGMP guidelines * Ability to work in a collaborative team environment * Good verbal and written communication skills * Must have good working knowledge of MS Excel and Word Show moreShow less