Genezen

Genezen

QC Senior/Principal Scientist, Analytical Method Validation

Lexington, MA · Principal

Work authorization required$120k-$160kDetected 77 days ago
Data AnalysisStatisticsProject ManagementExcelClinical TrialsGMPFDA RegulatoryqPCRCRISPRMolecular BiologyMass SpectrometryProtein AnalysisWestern BlottingLeadershipCommunicationMentoringWritingAdaptabilityOrganizational Skills

About the role

  • The QC Senior/Principal Scientist for Analytical Method Validation is key role within our Quality Control Technical Services (QCTS) department within our CDMO facility.
  • The individual in this role will work collaboratively with new and current clients, analytical development team, quality control, manufacturing and quality assurance.
  • Works independently and is responsible for optimization, qualification, transfer and validation of analytical methods associated with cGMP production.

Responsibilities

  • Support cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, out-of-specification (OOS) results, and other investigations or assay troubleshooting.
  • Provide coaching to QCTS scientists and develop and contribute to their technical development
  • Lead training of new analytical methods and support QC analysts on execution, data analysis and technical review of data generated in GMP lab.
  • Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency

Requirements

  • Adaptability required as work schedule may change based on business needs
  • Criminal background check required
  • Scientist to design and qualify critical materials required for cell based methods to support phase appropriate readiness
  • Assure that laboratory procedures are current and facilitate updates as required
  • Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning

Nice to have

  • Minimum 8 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer.
  • Prior experience with analytical method validations, analytical data trending/statistical analysis
  • Understanding of QC instrument qualification is preferred.
  • Thorough understanding of industry testing requirements/standards
  • Preferred experience with performing cell based bioassays using mammalian cell-lines (such as HELA, HEK-293, Huh-7 etc.) along with QC instrument qualification is essential.
  • Thorough understanding of industry testing requirements/standards related to gene/cell therapy products.
  • Working knowledge of quality systems requirements

Skills

  • Ph.D or MS in Molecular Biology/Biochemistry or other related Life Sciences
  • Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.)
  • Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential
  • Proven demonstration of technical writing skills such as protocol, reports, procedures etc.
  • Effective project management and presentation skills
  • Good/effective communication and organizational skills with the ability to work well with others and independently
  • Ability to work collaboratively with cross functional departments

Compensation

  • Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
  • Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
  • Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
  • Occasionally exposed to extremely loud noise levels
  • Regularly sit for long periods of time
  • Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms

Benefits

  • Frequently utilize close vision and the ability to adjust focus
  • 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

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.
  • We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

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.