Manufacturing Science and Technology Associate/Project Coordinator (GMP)

Type: Contract, W2 only

Duration: 12 months

Location: Tucson, AZ

Pay: $30/hr-$32/hr, DOE

Please note that at this time, we are unable to sponsor employment authorization (both new and transfer)

A leading Global Biotech Company is seeking an MSAT Specialist/Project Coordinator to support the introduction of new assays, reagents, and bulk materials for tissue diagnostics into manufacturing processes. This role ensures the seamless integration of new products from Development into Operations, focusing on manufacturability, quality, cost, and schedule. You will leverage technical knowledge, project management skills, and lean manufacturing principles to support efficient, scalable, and compliant manufacturing practices.

Responsibilities:

Technical Transfer (70%)

• Execute product design transfer tasks from late-stage development through commercial launch.
• Coordinate process transfers from R&D to manufacturing sites (local or external) and track project milestones.
• Collaborate cross-functionally with Operations, Development, Regulatory, and Project teams to align on manufacturability, quality, and cost objectives.
• Document and integrate end-to-end manufacturing requirements and best practices, including scalability considerations, into transfer projects.
• Utilize project management methodologies to execute transfer activities, troubleshoot issues, and support the evaluation of new tools and technologies.
• Support process validation readiness by gathering necessary documentation and collaborating with Validation Engineers.
• Actively participate in training and mentorship to develop technical excellence within the design transfer team.

Quality, Safety, and Compliance (15%)

• Ensure all processes are conducted safely and adhere strictly to current Good Manufacturing Practices (cGMP), local, international, and company's standards.
• Assist in audit readiness by collecting and organizing documentation, and supporting non-compliance events (e.g., NCR investigations and corrective actions).
• Keep updated with relevant regulations to maintain company compliance.

Continuous Improvement (15%)

• Learn and apply basic Lean principles and problem-solving methodologies (e.g., Five Whys, Fishbone diagrams) to identify and eliminate process inefficiencies.
• Use statistical tools and software (e.g., Minitab) to analyze process data, minimize risk, and generate actionable plans for improvements.
• Develop and maintain standardized procedures and documentation for processes.

Qualifications:

• Bachelor's or Master's degree in Life Sciences (Biology, Chemistry, Biochemistry, Physiology, etc.) or Engineering (Biomedical/Chemical) discipline.
• Minimum of 1 year of directly relevant work experience, preferably within the pharmaceutical, biotechnology, or medical devices industry.
• Foundational knowledge in applying scientific methods and principles to process transfer tasks, focusing on learning how to document and incorporate basic design and manufacturing elements while supporting a design for manufacturability approach.
• Basic understanding of the end-to-end production process for assays and reagents (formulation, filling, and packaging).
• Advanced technical writing skills to produce reports and documents.
• Experience operating in a GMP/regulated environment. Basic knowledge of Lean principles. Familiarity with Six Sigma methodologies is a plus.
• Proven ability to strictly follow standard operating procedures (SOPs), operational procedures (OPs), and quality protocols, ensuring compliance and data integrity.

We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs.