Genezen
Overview
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.
Working at Genezen Manypeople 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.
Job Summary The individual in this role will work collaboratively with the analytical development, quality control, and quality assurance teams to support successful transfer and implementation of QC analytical methods for the testing of viral vectors and gene therapy products in support of Genezen's services and commercial products. The role includes executing assays, training personnel, managing materials, and generating documentation in compliance with cGMP standards and regulatory guidelines. Additionally, the role contributes to critical material and method lifecycle management and documentation.
Essential Job Functions
Support the implementation and technology transfer of QC analytical methods, including assay execution, personnel training, procurement of materials and reagents, documentation generation, and facilitation of knowledge transfer.
Execute Performance Qualification (PQ) activities for new equipment.
Compile and analyze data to support tech transfer and method implementation.
Draft and revise equipment operational SOPs and method SOPs/worksheets in accordance with cGMP.
Receive training on new analytical methods and support assay execution during tech transfer.
Conduct QC Operations training for new methods and equipment.
Manage Bill of Materials (BOM) creation and coordinate procurement for tech transfer activities.
Lead inventory maintenance of critical materials, including freezer mapping and QC handoffs.
Support lifecycle management of critical materials, including qualification/re-qualification and COA review and generation.
Assist with data trending and compilation of trend reports.
Support drafting of protocols and reports for QC method transfer, qualification, verification, and validation.
Review, revise, and maintain procedures, including protocols and technical reports.
Assist in lifecycle maintenance of laboratory procedures and SOP updates.
Support QMS related activities by generating documentation to support change controls, deviations and investigations in eDMS systems.
Assist in assay troubleshooting and support continuous improvement initiatives.
Special Job Requirements
Adaptability required as work schedule may change based on business needs.
Criminal background check required.
Other duties as assigned.
Knowledge, Skills and Experience
Education:
BS or higher degree in Biology, Biochemistry, Molecular Biology or related Life Sciences.
On-the-job experience:
5+ years of relevant industry experience in QC and 2+ years of relevant experience with gene therapy/viral vector production.
Experience with laboratory techniques (qPCR, ddPCR, ELISA, cell-based assays, etc.).
Computer/software literacy (MS Word, Excel, JMP, Minitab, LIMS, etc.).
Proficiency in technical writing (protocols, reports, procedures).
Strong communication and organizational skills.
Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork are essential.
Ability to manage workload based on changing priorities.
Ability to work collaboratively with cross-functional departments.
Physical Demands
Regularly sit for long periods of time.
Frequently required to stand, sit, walk, balance and perform repetitive tasks.
Occasionally required to walk, climb, or balance, and stoop, kneel, crouch, or crawl.
Frequently lift and/or move up to 10 pounds; rarely lift and/or move 25 pounds.
Requires vision to communicate by talking, hearing, using telephone and e-mail.
Genezen's Value-Based Competencies
C ommitted to Science – we are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
U rgency in action for the patients – we operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners’ programs.
R esilience & Grit in operations – we are committed to overcoming challenges, learning from failures, and persistently striving for success.
E xecute with Excellence & Integrity – we are dedicated to delivering quality results and upholding ethical principles.
S olutions driven for our partners – we are committed to being a proactive, collaborative, creative and open-minded partner.
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.
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.
This position requires a criminal background check.
Locations Genezen has operations in two locations: Fishers, Indiana and Lexington, Massachusetts.
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Working at Genezen Manypeople 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.
Job Summary The individual in this role will work collaboratively with the analytical development, quality control, and quality assurance teams to support successful transfer and implementation of QC analytical methods for the testing of viral vectors and gene therapy products in support of Genezen's services and commercial products. The role includes executing assays, training personnel, managing materials, and generating documentation in compliance with cGMP standards and regulatory guidelines. Additionally, the role contributes to critical material and method lifecycle management and documentation.
Essential Job Functions
Support the implementation and technology transfer of QC analytical methods, including assay execution, personnel training, procurement of materials and reagents, documentation generation, and facilitation of knowledge transfer.
Execute Performance Qualification (PQ) activities for new equipment.
Compile and analyze data to support tech transfer and method implementation.
Draft and revise equipment operational SOPs and method SOPs/worksheets in accordance with cGMP.
Receive training on new analytical methods and support assay execution during tech transfer.
Conduct QC Operations training for new methods and equipment.
Manage Bill of Materials (BOM) creation and coordinate procurement for tech transfer activities.
Lead inventory maintenance of critical materials, including freezer mapping and QC handoffs.
Support lifecycle management of critical materials, including qualification/re-qualification and COA review and generation.
Assist with data trending and compilation of trend reports.
Support drafting of protocols and reports for QC method transfer, qualification, verification, and validation.
Review, revise, and maintain procedures, including protocols and technical reports.
Assist in lifecycle maintenance of laboratory procedures and SOP updates.
Support QMS related activities by generating documentation to support change controls, deviations and investigations in eDMS systems.
Assist in assay troubleshooting and support continuous improvement initiatives.
Special Job Requirements
Adaptability required as work schedule may change based on business needs.
Criminal background check required.
Other duties as assigned.
Knowledge, Skills and Experience
Education:
BS or higher degree in Biology, Biochemistry, Molecular Biology or related Life Sciences.
On-the-job experience:
5+ years of relevant industry experience in QC and 2+ years of relevant experience with gene therapy/viral vector production.
Experience with laboratory techniques (qPCR, ddPCR, ELISA, cell-based assays, etc.).
Computer/software literacy (MS Word, Excel, JMP, Minitab, LIMS, etc.).
Proficiency in technical writing (protocols, reports, procedures).
Strong communication and organizational skills.
Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork are essential.
Ability to manage workload based on changing priorities.
Ability to work collaboratively with cross-functional departments.
Physical Demands
Regularly sit for long periods of time.
Frequently required to stand, sit, walk, balance and perform repetitive tasks.
Occasionally required to walk, climb, or balance, and stoop, kneel, crouch, or crawl.
Frequently lift and/or move up to 10 pounds; rarely lift and/or move 25 pounds.
Requires vision to communicate by talking, hearing, using telephone and e-mail.
Genezen's Value-Based Competencies
C ommitted to Science – we are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
U rgency in action for the patients – we operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners’ programs.
R esilience & Grit in operations – we are committed to overcoming challenges, learning from failures, and persistently striving for success.
E xecute with Excellence & Integrity – we are dedicated to delivering quality results and upholding ethical principles.
S olutions driven for our partners – we are committed to being a proactive, collaborative, creative and open-minded partner.
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.
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.
This position requires a criminal background check.
Locations Genezen has operations in two locations: Fishers, Indiana and Lexington, Massachusetts.
#J-18808-Ljbffr