Scientist I, Analytical Development

Genezen • Lexington, MA

70d

About The Position

Lead the establishment of methods in the Analytical Development (AD) and Quality Control lab from the bench. This individual will be accountable for development and validation of analytical and QC assays, equipment specification and selection and the direction of analytical method transfer from the analytical development lab to the QC lab while operating under cGMP standards. 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.

Requirements

• 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).
• Expertise in the biophysical characterization of AAV particles and associated impurities.
• 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.

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.
• 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.
• Supervise and train AD Associates and AD Technicians 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees