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David Careers

Scientist I, Analytical Development

Posted 5 days ago

genezenLexington (MA)
ChemistsResearch and Development in Biotechnology

SENIORITY

Senior

SALARY

$85,000-$110,000

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About the role

Scientist I, Analytical Development Lexington, MAThe 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.
Job Summary: 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
Job 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.
  • 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 ELNWork 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
  • 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 ExperienceEDUCATION / CERTIFICATIONS / LICENSES - Essential/DesiredBS in scientific/technical discipline - EssentialON-THE-JOB EXPERIENCE2-4 years of CRO/CDMO experience in design, development and execution of bioanalytical methods (i.e. method development, qualification, validation and transfer). - Essential Direct hands on experience with MALS and CAD detectors in AAV analytics - Essential Expertise in the biophysical characterization of AAV particles and associated impurities. - EssentialExperience with LC-MS based assay development. - EssentialExperience with documentation and reporting of results using electronic lab notebooks - EssentialSKILLS / ABILITIESPeople training and leadership skills - Essential Ability to maintain multiple projects and timelines - Essential Excellent verbal and written communication skills - Essential Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills - Essential
Pay Range: The annual salary range for the Scientist I is $85,000-$110,000.Physical Demands While performing the duties of this job, the employee is required to meet the following physical demands:
  • Work Environment
  • 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
  • MovementFrequently 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
  • LiftingFrequently lift and/or move up to 10 pounds
  • Occasionally lift and/or move up to 25 pounds
  • VisionFrequently utilize close vision and the ability to adjust focus
  • CommunicationFrequently required to communicate by talking, hearing, using telephone and e-mail
  • Genezen's Cures Value-Based Competencies
Committed to Science We are committed to scientific 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. Genezen's Benefits Paid vacation days, amount based on tenure Paid sick time10 observed holidays + 2 floating holiday + 1 volunteer day 401(k) plan with company match up to 6% of salary Share Appreciation RightsChoice of several healthcare plansFSA 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
Additional Details: 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.

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