Summary of Major Responsibilities
The Senior Associate Scientist I, Assay Transfer will assist in a variety of design and test method transfer activities within operations. This position is primarily responsible for assisting the transfer and implementation of analytical and functional tests used to characterize and release products in operations. Additional responsibilities include, but is not limited to, collaborating with other departments to define test method requirements and development of new methods, as needed.
Essential Duties and Responsibilities
- Provide design and test method transfer support to operations by working cross-functionally with the production, quality control, supply chain, research and development (R&D), systems development, and quality teams.
- Support test method design and transfer via test method transfer forms/plans, characterization studies, method development reports, and quality specification documents through collaboration, experiment design, study execution, data analysis, and reporting.
- Lead and assist in training and knowledge transfer of test method development and execution.
- Generate experimental protocols, draft test method procedures, characterize test methods, and summarize activities clearly and accurately through general reports.
- Program and operate complex instrumentation such as micro plate readers, real-time polymerase chain reaction (PCR) instruments, analytical instruments; including, but not limited to, high performance liquid chromatography (HPLC), auto titrators, densitometers, spectrophotometers, and liquid handling automation.
- Troubleshoot automated liquid handling instrumentation, detection equipment, functional assays, and analytical methods.
- Support development and validation of automated liquid handling instrumentation and methods.
- Conduct bench level experiments within several product or technology areas to generate valuable product knowledge.
- Ability to effectively communicate with multi-level personnel as well as outside vendors and their representatives.
- Effective analytical, problem solving, and decision-making skills.
- Ability to work effectively independently and in team situations.
- Excellent oral and written communication, interpersonal, and presentation skills.
- Strong attention-to-detail.
- Ability to prioritize tasks and adhere to project schedules and timelines.
- Ability to thrive in a fast-paced, frequently changing, and evolving environment.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to lift up to 40 pounds on an occasional basis.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to use various types of laboratory equipment including microscopes, microtomes, blades, strainers, pipettes for extended periods of time.
- May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
- Ability and means to travel between Madison locations.
- Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
- Bachelor’s degree in life sciences or related field as outlined in the essential duties.
- 4+ years of biotechnology industry experience.
- 4+ years of experience with medical device products in a product development or assay transfer role.
- 4+ years working within an FDA regulated 21 CFR 820 environment, ISO 13485, ISO 12207, and/or cGMP structured environment.
- 4+ years of experience with in vitro diagnostic (IVD) product manufacturing processes, biochemical, molecular, and real-time-PCR assays, and/or analytical assays.
- 2+ years of experience with project management principles and practice.
- Professional working knowledge of design of experiments (DOE), measurement system analysis (MSA), characterization study design, and hypothesis testing.
- Proficient in a variety of common laboratory skills and techniques with base knowledge in chemistry, biochemistry, and/or molecular biology.
- Coursework or proficient working knowledge of statistical and mathematical methods; including, but not limited to, proficiency in JMP software.
- Proficient in Microsoft Office.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
- Master’s degree in life sciences or related field as outlined in the essential duties.