Scientist I, Analytical Development
Genezen
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Job summary
Genezen, based in Lexington, MA, seeks a Scientist I to lead method establishment in Analytical Development and QC for biophysical characterization of AAV particles using HPLC with CAD and MALS detectors. You will validate analytical methods, shepherd tech transfer, and work under cGMP with cross-functional teams.
Requires 2–4 years CRO/CDMO bioanalytical experience, hands-on MALS/CAD, LC-MS, and ELN/LIMS familiarity; strong leadership and communication skills are essential.
Qualifications
- 2-4 years CRO/CDMO experience in design, development and execution of bioanalytical methods (i.e. method development, qualification, validation and transfer).
- Direct hands on experience with MALS and CAD detectors in AAV analytics
- Expertise in the biophysical characterization of AAV particles and associated impurities.
- Experience with LC-MS based assay development
- Experience with documentation and reporting of results using electronic lab notebooks
Responsibilities
- Expert in HPLC based methodology development and establishment including with the use of CAD and MALS detectors for use in the characterization of AAV vectors.
- Operate HPLC associated equipment including equipment troubleshooting as required.
- Extensive experience with the use of ASTRA software.
- Familiarity with OpenLab software for the analysis of HPLC based readouts.
- Maintain familiarity with other current analytical and bioassay methods, including Flowcytometry, ELISA, qPCR and ddPCR based assays in Lenti, Retro and AAV platforms.
- 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.
- Assist with training AD Associates and other team members where needed and work closely with other departments, assisting in project planning
- Support the establishment of electronic record keeping systems for site; e.g. LIMS or ELN
- 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
- 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
Skills
Education
Tools
Job description
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.
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.
Lead the establishment of methods in the Analytical Development (AD) and Quality Control lab from the bench. This is a hands on position that requires technical expertise and ability to design and execute experiments for the biophysical characterization of viral vector particles. This individual will be accountable for development and validation of analytical and QC assays, equipment specification and selection. The incumbent will also be responsible for analytical method from the analytical development lab to the QC lab while operating under cGMP standards under guidance from department head and QC/QCTS leadership. 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 position requires expertise in the biophysical characterization of AAV particles with an emphasis on HPLC based methodology using various detectors including UV-Vis, CAD, and MALS detectors. Experience using Astra software for SEC-MALS analysis is required
- Expert in HPLC based methodology development and establishment including with the use of CAD and MALS detectors for use in the characterization of AAV vectors.
- Expected to be able to operate HPLC associated equipment including equipment troubleshooting as required.
- Extensive experience with the use of ASTRA software.
- Familiarity with OpenLab software for the analysis of HPLC based readouts.
- Maintain familiarity with other current analytical and bioassay methods, including Flowcytometry, ELISA, qPCR and ddPCR based assays in Lenti, Retro and AAV platforms.
- 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.
- Assist with training AD Associates and other team members where needed and work closely with other departments, assisting in project planning
- Support the establishment of electronic record keeping systems for site; e.g. LIMS or ELN
- 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
- 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
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
BS in scientific/technical discipline
2-4 years of CRO/CDMO experience in design, development and execution of bioanalytical methods (i.e. method development, qualification, validation and transfer).
Direct hands on experience with MALS and CAD detectors in AAV analytics
Expertise in the biophysical characterization of AAV particles and associated impurities.
Experience with LC-MS based assay development.
Experience with documentation and reporting of results using electronic lab notebooks
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
The annual salary range for the Scientist I is $85,000-$110,000.
While performing the duties of this job, the employee is required to meet the following physical demands:
- Frequently required to work in BSL2 environment with personal protective equipment/aseptic gowning
- Occasionally exposed to moving mechanical parts, toxic or caustic chemicals, hazardous waste, and similar hazards associated with pharmaceutical lab facilities
- 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
Committed to Science
We are committed toscientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
- Paid vacation days, amount based on tenure
- 401(k) plan with company match up to 6% of salary
- Choice of several healthcare plans
- FSA and HSA programs
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- 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.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
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