Scientist I, Analytical Development

Genezen•Indianapolis, IN

About The Position

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 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. JOB SUMMARY We are looking for someone with high emotional intelligence and is comfortable working closely across the team to join us in facilitating the production of viral vectors. The Scientist role will be responsible for developing, implementing and qualifying analytical methods in addition to sample testing. The role will require close collaboration with Process Development and Quality Control as well as a flexible mindset to adjust to shifting dynamics within the organization.

Requirements

BS degree in scientific/technical discipline
BS with 5-7 years of CRO/CDMO or pertinent industry experience in bioanalytical methods (development, qualification and transfer)
Familiarity with aseptic technique and cell culture
Experience with PCR methods, flow cytometry, and ELISAs
Strong people leadership skills
Ability to interpret and analyze data, define problems, establish facts, draw valid conclusions and make decisions
Ability to maintain multiple projects and timelines
Excellent verbal and written communication skills
Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills
Adaptability required as work schedule may change based on business needs
Criminal background check required
Other duties as assigned

Nice To Haves

PhD in a scientific discipline
PhD with 0 – 2 years of pertinent experience
Proven assay qualification/validation experience
3+ years of cGXP experience
Experience with documentation and reporting of results using electronic lab notebooks

Responsibilities

Develop, optimize and standardize analytical methods for viral vector characterization, including Lentiviral (LVV), Retroviral (RVV) and Adeno-associated Virus (AAV) vectors.
Execute assays involved in viral vector characterization using modalities like flow cytometry, ddPCR, ELISA and cell culture.
Assist with in-lab and out of lab (e.g., report writing) activities to qualify assays per ICH guidelines.
Plan and execute analytical timelines to meet program and corporate objectives.
Implement best laboratory practices to maintain efficiency, consistency and accuracy of work performed.
Train new staff members and fellow employees in designated processes.
Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory standards.
Maintain appropriate documentation of processing activities, including written and electronic data.
Assist with sample management for process development and clients.
Handle and track laboratory materials and inventory.
Help engage with new technology evaluations and incorporate new platforms.
Perform routine lab maintenance and maintenance of laboratory equipment.
Deal with abstract and concrete variables in situations where only limited standardization exists.
Contribute to a collaborative, creative and rigorous culture of scientific excellence.
Adaptability in schedules is highly required as work schedules may change based on business needs.
Intent to work with the manager on meeting the company mission, vision and values to achieve department goals.
Criminal background check required.
Other duties as assigned.