Analytical Development Research Associate (Open Rank)

Wheeler Bio is seeking a motivated analytical mind with a passion for problem solving and fast-paced environments to join the analytical team. The Analytical Development Research Associate will participate in the development of robust analytical techniques designed for seamless transition to a quality control environment in a manner to emphasize “right first time” and prolonged success. The position will require scientific knowledge of bioanalytical techniques that are used to assess and characterize proteins with a focus on monoclonal antibodies.

Responsibilities

• Possesses basic knowledge of protein biochemistry, analysis, and associated techniques.
• Participates in client analytical programs with a focus on quality and timeline.
• Assists in the development of new analytical methods, processes, or technologies.
• Participates in method qualifications and transfer to Quality Control.
• Authors analytical plans, protocols, SOPs, and summary reports.
• Understands and applies required techniques in support of projects and studies according to pre-defined plans and protocols.
• Maintains a laboratory notebook according to company guidelines.
• Uses and applies complex instrumentation, computer systems and software for data acquisition and analysis.
• Ability to work with team members to troubleshoot and solve complex problems to meet project needs.
• Ability to present scientific data regarding problems, updates, and/or results.
• Maintains analytical instrumentation as needed and interfaces with external vendors for instrument installation and operation qualifications.
• Ensures lab is maintained (organized, clean, properly supplied).
• As appropriate, participates in training of Quality Control, Process Development, and Manufacturing teams performing analytical techniques.
• Maintains continuous performance improvement metrics and participates in improvement strategies.
• Integrates ongoing quality and operational improvement strategies into workflows.
• Expands expertise to other types of assays.
• All other duties as may be assigned.

Knowledge / Skills / Experience Requirements

• Preferred Master’s or Bachelor’s degree (in biochemistry, chemistry, virology, microbiology, or other life-science discipline) with previous experience.
• Preferred knowledge of and experience with various analytical techniques (e.g., HPLC, ELISA, enzyme activity, BLI/SPR, mass spectrometry, bioassays) demonstrated through industry or academic performance.
• Preferred experience in assay development
• Ability to work independently with supervision.
• Work professionally as part of a team.
• Ability to work on multiple projects at once.
• Implementation of new methods and processes.
• Ability to generate technical reports and presentations.
• Ability to clearly communicate scientific information.
• Ability to write and perform detailed analytical procedures.
• Basic knowledge of FDA, ICH, EMA, JP, and other regulatory guidance on CGMP manufacturing.
• Experience with statistical analysis techniques and specialty software.

Working Conditions and Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Wheeler will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. While performing the duties of this job, the employee is regularly required to:

• Prolonged sitting, standing, walking, bending, stooping, and stretching
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopies, telephone, calculator, other office equipment, along with specialty analytical equipment such as pipettes
• Occasionally lifting 50 pounds maximum
• The position is offered to on-site and is not eligible to work from home