Manufacturing Operations Specialist

We’re seeking a Technical Transfer Specialist (Manufacturing Specialist) to join a dynamic team in Oro Valley, Arizona for a 12-month contract with the potential for extension. In this role, you’ll support the seamless introduction of new assays and reagents into manufacturing processes, focusing on quality, cost, and schedule. If you have experience in GMP environments and a background in Life Sciences or Engineering, we'd love to connect!

Job Title: Technical Transfer Specialist - Manufacturing Operations

Job Location: Oro Valley, Arizona 85755

Job Duration: 12 months with possible extension

THE OPPORTUNITY

The Technical Transfer Specialist supports the introduction of new assays, reagents, and bulk materials for tissue diagnostics into Roche's 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.

REQUIRED QUALIFICATIONS

Education: Bachelor’s or Master’s degree in a Life Sciences (Biology, Chemistry, Biochemistry, Physiology, etc.) or Engineering (Biomedical/Chemical) discipline.

Experience: Minimum of 1 year of directly relevant work experience, preferably within the pharmaceutical, biotechnology, or medical device industry.

Regulatory Experience: Experience operating in a GMP/regulated environment.

Lean Principles Knowledge: Basic knowledge of Lean principles. Familiarity with Six Sigma methodologies is a plus.

Skills: Excellent stakeholder management, communication, and project coordination skills.

Compliance: Proven ability to strictly follow standard operating procedures (SOPs), operational procedures (OPs), and quality protocols, ensuring compliance and data integrity.

Teamwork: Strong teamwork ethic and exceptional interpersonal skills, with the ability to effectively collaborate across multiple functions, anticipate team needs, and navigate a matrix organization.

KEY 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 Roche (MQMS) 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.

KNOWLEDGE, SKILLS, AND ABILITIES

Scientific Knowledge: 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.

Production Process Understanding: Basic understanding of the end-to-end production process for assays and reagents (formulation, filling, and packaging).

Technical Writing: Advanced technical writing skills to produce reports and documents.

Stakeholder Management: Excellent stakeholder management, communication, and project coordination skills.

Problem-Solving: Strong organizational, critical thinking, and problem-solving abilities, with the capacity to manage multiple low-complexity assignments and meet project deadlines.

Compliance Adherence: Proven ability to strictly follow standard operating procedures (SOPs), operational procedures (OPs), and quality protocols, ensuring compliance and data integrity.

Team Collaboration: Strong teamwork ethic and exceptional interpersonal skills, with the ability to effectively collaborate across multiple functions, anticipate team needs, and navigate a matrix organization.

Multi-tasking: Strong organizational, critical thinking, and problem-solving abilities, with the capacity to manage multiple low-complexity assignments and meet project deadlines.