Summary of Major Responsibilities

The Associate Scientist II, Technical Transfer role will assist in a variety of technical transfer and continuous improvement activities facilitating process and product transfer into Operations. This position will develop, document, validate, and implement new processes and procedures into production as part of the design transfer process.

Essential Duties and Responsibilities

• Assist in design and development of In Vitro Diagnostic (IVD) medical device manufacturing processes and procedures in accordance with cGMP, ISO13485, and FDA guidelines.
• Define, characterize, and proceduralize Critical Process Parameters (CPP), Proven Acceptable Ranges (PAR), and critical control points as an output of process design.
• Establish Production Work Instructions, Receiving Inspection Methods, Technical Summary Reports, Standard Operating Procedures (SOPs), and other technical and GMP manufacturing documents, as required.
• Support processes and exhibits capability through execution of development, pilot scale, and process validation batch production.
• Identify, source, and characterize novel manufacturing equipment.
• Support training and transfer of new processes and procedures to production operators.
• Work externally to understand raw material sourcing, specifications, and risks in collaboration with R&D and Supply Chain teams.
• Act as project team member for key business initiatives and continuous improvement projects.
• Participate in investigations and risk assessment activities; including Process Failure Mode Effects Analysis (pFMEA).
• Work collaboratively with Production, R&D, Quality Engineering, Regulatory Affairs, Supply Chain, and other cross-functional areas, as necessary.
• Ability to design basic experimental plans and interpret technical data.
• Ability to effectively work on several varied projects at one time, with frequent changing priorities.
• Strong analytical and problem-solving skills.
• Ability to work effectively in team situations, as well as independently.
• Ability to collaborate across functions and within a workgroup to meet business objectives.
• Excellent oral and written, communication, interpersonal, and presentation skills.
• Strong attention-to-detail.
• Ability to prioritize tasks and adhere to project schedules and timelines 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 50 pounds for approximately 5% of a typical working day.
• 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, and 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 10% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

• Bachelor's degree in Biology, Molecular Biology, Chemistry, or a science related field; or Associates degree and 2 years of relevant experience in Biology, Molecular Biology, Chemistry, or a science related field in lieu of bachelor's degree.
• 1+ years of experience working in a life sciences manufacturing setting.
• Proficient in a variety of common laboratory skills and techniques with a base knowledge in chemistry, biochemistry, molecular biology, or a related field.
• Professional working knowledge or coursework with IVD product manufacturing processes, Biochemical, Molecular, and Real-Time-PCR Assays.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 2+ years of experience with medical device products in a cGMP manufacturing and/or technical role.
• Knowledge in Design for Six Sigma and Statistics.
• Knowledge in continuous improvement methodologies/principles; such as LEAN Six Sigma.
• Experience with project management principles and practice.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.