Genezen
Sr. Engineer, Manufacturing Sciences & Technology
Genezen, Lexington, Massachusetts, United States, 02173
Sr. Engineer, Manufacturing Sciences & Technology
Location: Lexington, MA The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, GMP viral vectors, and cell transduction for gene and cell therapy clinical trials. Overview
The Global MSAT group plays a critical role in successful manufacturing of clinical and commercial products. The person in this role assists MSAT team in the transfer of technologies, process validation and cGMP manufacturing of Genezen’s gene therapy products. Responsibilities
Lead all aspects of process technology transfer from early and late-stage process development for clinical and commercial manufacturing. Provide technical support to manufacturing and write product impact assessments to support deviations. Provide input on scope of work proposals to ensure clients’ goals are met. Cross-functional collaboration with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation and Supply Chain as needed. Ensure successful manufacturing production runs by assessing risk, setting preventative measures, investigating, and troubleshooting equipment and process issues. Lead client-facing meetings regarding technical topics and scope of work progress. Provide impact assessments and aid in root-cause analysis for critical deviations and determine CAPAs for manufacturing. Author technical documentation: protocols and reports. Assist process validation studies to develop a thorough understanding of operating and performance parameters. Support data monitoring and trending analysis using statistical process control charts. Special Job Requirements
Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner. Experience with customer-facing discussions. Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis). Knowledge, Skills and Experience
Education / Certifications / Licenses Bachelor's Degree in Engineering or related scientific discipline. Master's Degree in Engineering or related scientific discipline. On-the-Job Experience 6+ (BS) or 4+ (MS) or 0-2 (PhD) years of relevant experience in gene therapy or other biotechnology industry. Skills / Abilities Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing. Good understanding of upstream and downstream processes of viral vectors, cell therapy, or recombinant biologics. Essential Ability to present to and interact with clients on behalf of the MSAT team. Experience developing and executing tech transfer into GMP manufacturing. Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner. Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis). Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal. Proven knowledge and experience of risk-based approaches to process development and validation. Demonstrated knowledge in cell culture and cell & virus banking. Ability to cope with many topics in parallel, strict timelines and pressure. Knowledge of current pharmaceutical, regulatory, and technology trends. Knowledge of data management tools and statistical process controls. Physical Demands
Relevant physical demands include: Regularly sit for long periods. Movement: stand, sit, use hands, reach with hands and arms; occasional walking, climbing/balancing, kneeling, crouching or crawling. Lifting: frequently up to 10 pounds; occasionally up to 25 pounds. Vision: frequent close vision and focus adjustment. Communication: frequently communicate by talking, hearing, telephone and e-mail. Benefits
Paid vacation days, amount based on tenure 401(k) plan with company match up to 6% of salary, vested immediately Choice of several healthcare plans FSA and HSA programs Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance EEO / Additional Details
Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
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Location: Lexington, MA The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, GMP viral vectors, and cell transduction for gene and cell therapy clinical trials. Overview
The Global MSAT group plays a critical role in successful manufacturing of clinical and commercial products. The person in this role assists MSAT team in the transfer of technologies, process validation and cGMP manufacturing of Genezen’s gene therapy products. Responsibilities
Lead all aspects of process technology transfer from early and late-stage process development for clinical and commercial manufacturing. Provide technical support to manufacturing and write product impact assessments to support deviations. Provide input on scope of work proposals to ensure clients’ goals are met. Cross-functional collaboration with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation and Supply Chain as needed. Ensure successful manufacturing production runs by assessing risk, setting preventative measures, investigating, and troubleshooting equipment and process issues. Lead client-facing meetings regarding technical topics and scope of work progress. Provide impact assessments and aid in root-cause analysis for critical deviations and determine CAPAs for manufacturing. Author technical documentation: protocols and reports. Assist process validation studies to develop a thorough understanding of operating and performance parameters. Support data monitoring and trending analysis using statistical process control charts. Special Job Requirements
Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner. Experience with customer-facing discussions. Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis). Knowledge, Skills and Experience
Education / Certifications / Licenses Bachelor's Degree in Engineering or related scientific discipline. Master's Degree in Engineering or related scientific discipline. On-the-Job Experience 6+ (BS) or 4+ (MS) or 0-2 (PhD) years of relevant experience in gene therapy or other biotechnology industry. Skills / Abilities Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing. Good understanding of upstream and downstream processes of viral vectors, cell therapy, or recombinant biologics. Essential Ability to present to and interact with clients on behalf of the MSAT team. Experience developing and executing tech transfer into GMP manufacturing. Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner. Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis). Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal. Proven knowledge and experience of risk-based approaches to process development and validation. Demonstrated knowledge in cell culture and cell & virus banking. Ability to cope with many topics in parallel, strict timelines and pressure. Knowledge of current pharmaceutical, regulatory, and technology trends. Knowledge of data management tools and statistical process controls. Physical Demands
Relevant physical demands include: Regularly sit for long periods. Movement: stand, sit, use hands, reach with hands and arms; occasional walking, climbing/balancing, kneeling, crouching or crawling. Lifting: frequently up to 10 pounds; occasionally up to 25 pounds. Vision: frequent close vision and focus adjustment. Communication: frequently communicate by talking, hearing, telephone and e-mail. Benefits
Paid vacation days, amount based on tenure 401(k) plan with company match up to 6% of salary, vested immediately Choice of several healthcare plans FSA and HSA programs Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance EEO / Additional Details
Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
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