Lab Tech, Analytical Development (Temp)
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. 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. Develop and execute analytical methods for the characterization and release of therapeutic viral vectors. This individual will be accountable for method development, intake from partner organizations, as well as transfer from the analytical development unit to quality control. The person is expected to work collaboratively with the team to establish and implement best regulatory, laboratory practices and to lead the execution of complex experiments. The successful candidate will have previous hands-on experience with potency assay development and execution for AAV as well as with ddPCR, qPCR and ELISA.
Requirements
- BS in scientific/technical discipline
- People training and leadership skills
- Ability to maintain multiple projects and timelines
- Excellent verbal and written communication skills
- Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills
Nice To Haves
- Previous hands-on experience with potency assay development and execution for AAV
- Previous hands-on experience with ddPCR, qPCR and ELISA
Responsibilities
- Direct hands-on experience developing and executing cell-based potency assays
- Direct hands-on experience developing and executing ddPCR and qPCR molecular assays
- Direct hands-on experience developing and executing ELISA methods
- Maintain familiarity with current equipment used in Analytics lab
- Help management evaluate new technology and bring new platforms in-house
- Qualify/validate analytical methods to support cGMP testing
- Help facilitate tech transfer of analytical and bioassays from clients to AD lab and from AD lab to QC lab
- Support the establishment of electronic record keeping systems for site; e.g. LIMS or eLN
- Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of biological products
- Work as a team with process development, manufacturing, quality assurance and quality control departments as needed
- Advise site and quality management of potential and actual actions that could adversely affect the business represent quality exposures, or represent opportunities to be pursued
- Execute research timelines to meet program and corporate objectives
- Deal with abstract and concrete variables in situations where only limited standardization exists
- Maintain high quality deliverables and open communication, creating a collaborative working environment
- Contribute to collaborative, creative and rigorous culture of scientific discovery
- Provide weekly reports to department head in 1:1 environment
Benefits
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
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What This Job Offers
Career Level
Entry Level
