Genezen

Genezen

Process Engineer III, Manufacturing Sciences & Technology

Lexington, MA · Mid

Work authorization required$105k-$130kDetected 7 days ago
Data AnalysisStatisticsProject ManagementProcess ImprovementCustomer SupportClinical TrialsGMPFDA RegulatoryCRISPRCommunicationPublic SpeakingOrganizational Skills

About the role

  • The MSAT group plays a critical role in successful manufacturing of clinical and commercial products.
  • The person in this role assists in the transfer of technologies, process validation and cGMP manufacturing of products.
  • This individual will contribute as a core member of various cross-functional teams, and interacts extensively with other departments within Genezen, including Process Development, Manufacturing, Engineering, Quality, and Regulatory Affair etc..

Responsibilities

  • Supports downstream processing unit operations for process implementation, data collection, data analysis, and real time troubleshooting (i.e. chromatography, filtration, TFF, buffer generation, drug product filling)
  • Assist technology transfer to GMP manufacturing by reviewing process description documents, technology transfer reports, reviewing master batch records, and providing on-floor support for transfer operations
  • Assist manufacturing technical support, including process trouble-shooting, root cause analysis and investigation on process and/or quality discrepancies and deviations during GMP productions, change controls and CAPAs
  • Support plan and execution of process/product life cycle management, including continuous process improvement to improve robustness/capacity/productivity, and to increase level of safety and/or compliance
  • We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
  • S olutions driven for our partners
  • We are committed to being a proactive, collaborative, creative and open-minded partner.

Requirements

  • Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)
  • Criminal background check required
  • Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems
  • Ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands
  • Frequently required to stand
  • Occasionally required to walk
  • While performing the duties of this job, the employee is required to meet the following physical demands:

Nice to have

  • Experience with technology transfer and GMP manufacturing technical support is preferred

Skills

  • BS/MS or degree in Engineering or other related scientific discipline preferred
  • Regularly sit for long periods of time
  • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
  • Frequently lift and/or move up to 10 pounds
  • Occasionally lift and/or move up to 25 pounds
  • Frequently utilize close vision and the ability to adjust focus
  • Frequently required to communicate by talking, hearing, using telephone and e-mail
  • Essential/Desired
  • Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal
  • Strong communication skills, including writing and oral presentations
  • Experienced project management skills

Compensation

  • 401(k) plan with company match up to 6% of salary
  • The annual salary range for this position is $105,000-$130,000.

Benefits

  • Paid vacation days, amount based on tenure
  • 10 observed holidays + 2 floating holiday + 1 volunteer day
  • Choice of several healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Voluntary disability, universal life/personal accident insurance
  • We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
  • We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Company info

  • The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients.
  • We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
  • Many people have worked in environments where you feel like just another nameless part of an enormous machine.
  • Genezen is different.
  • We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company.
  • We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.
  • Every employee contributes to the success of the company and you can be part of that team.

Equal opportunity

  • Genezen is an Equal Opportunity Employer.

Visa & Work Authorization

  • en 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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This listing is sourced directly from Genezen's careers page and normalized into a canonical job model.