Senior Associate Scientist, Technical Transfer

Summary of Major Responsibilities

Essential Duties and Responsibilities

• Assist in the design and development of In Vitro Diagnostic (IVD) medical device manufacturing processes and procedures in accordance with cGMP, ISO13485, and FDA guidelines.
• Lead or assist in process development, training, and pilot scale manufacturing for moderately complex processes and products, as well as more complex buffers.
• Define, characterize, and proceduralize Critical Process Parameters (CPP), Proven Acceptable Ranges (PAR), and critical control points as an output of process design.
• Ability to characterize basic test method variability, design and coordinate execution of basic measurement system analysis studies, and propose specifications with support from subject matter experts for simple measurement systems.
• Establish Production Work Instructions, Receiving Inspection Methods, Technical Summary Reports, Standard Operating Procedures, and other technical and GMP manufacturing documents as required.
• Identify, source, and characterize novel manufacturing equipment.
• Support or lead training and transfer of new processes and procedures to production operators.
• Work externally to understand raw material sourcing, specifications, and risks in collaboration with research and development (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 frequently 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 grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to comply with any applicable personal protective equipment requirements.
• 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

• Bachelor's degree in biology, molecular biology, chemistry, or other science related field as outlined in the essential duties; or Associate's degree in biology, molecular biology, chemistry, or other science related field as outlined in the essential duties and 2 years of relevant experience in biology, molecular biology, chemistry, or a science related field in lieu of Bachelor’s degree.
• 4+ years of experience working with medical device products in a cGMP manufacturing and/or technical role.
• Proficient in a variety of common laboratory skills and techniques with a base knowledge in chemistry, biochemistry, molecular biology, or science related field as outlined in the essential duties.
• Demonstrated understanding of 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.

• 4+ years of experience working on IVD product development and manufacturing.
• Experience with project management principles and practices.
• Knowledge in design for Six Sigma and statistics.
• Knowledge in continuous improvement methodologies and principles, such as LEAN Six Sigma.