Position Title: Technical Transfer Specialist - Manufacturing Operations
Work Location: Tucson AZ
Assignment Duration: 12 Months
Work Arrangement: Onsite

Position Summary:

• This opening is for an onsite Technical Transfer Specialist in Manufacturing Operations. The Technical Transfer Specialist supports the introduction of new assays, reagents, and bulk materials for tissue diagnostics into The Organization's manufacturing processes.
• This role ensures the seamless integration of new products from Development into Operations, focusing on manufacturability, quality, cost, and schedule.

Key Responsibilities:

• 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.
• Ensure all processes are conducted safely and adhere strictly to current Good Manufacturing Practices (cGMP), local, international, and The Organization 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.
• 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.

Qualification & Experience:

• Bachelor's or Master's degree in a 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.
• Experience operating in a GMP/regulated environment.
• Basic knowledge of Lean principles. Familiarity with Six Sigma methodologies is a plus.
• Excellent stakeholder management, communication, and project coordination skills.
• Proven ability to strictly follow standard operating procedures (SOPs), operational procedures (OPs), and quality protocols, ensuring compliance and data integrity.
• Strong teamwork ethic and exceptional interpersonal skills, with the ability to effectively collaborate across multiple functions, anticipate team needs, and navigate a matrix organization.
• Basic Technical Problem-Solving: Candidates must have indirect or academic experience in troubleshooting, technical projects, or lab work (e.g., from college courses, a master’s program, or tutoring). Direct industry experience is not required.
• Collaboration & Independence: Candidates must work well with different teams and be capable of managing their own daily tasks independently after initial onboarding and training.
• Strong Professional Communication: Candidates must have great interpersonal skills, know how to self-manage their workload, and be comfortable escalating issues when needed.
• Curiosity & Eagerness to Learn: Well suited candidates should display a growth mindset, a strong willingness to learn, and the confidence to ask questions (e.g., a great fit for a recent grad or someone transitioning from a technician role).
• 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.
• Strong organizational, critical thinking, and problem-solving abilities, with the capacity to manage multiple low-complexity assignments and meet project deadlines.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 30.00/hr.