Summary of Major Responsibilities
The Senior Associate Scientist, Technical Transfer will lead or assist in a variety of technical transfer and continuous improvement activities that facilitate 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 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.
- 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.