Technical Transfer Specialist - Manufacturing Operations

The Technical Transfer Specialist supports the introduction of new assay reagents and bulk materials for tissue diagnostics into manufacturing operations. This role ensures the seamless integration of new products from Development into Operations, with a strong focus on manufacturability, quality, cost, and schedule. You will apply your technical expertise, project management capabilities, and understanding of lean manufacturing principles to enable efficient, scalable, and compliant manufacturing practices in a regulated environment.

Responsibilities

• Execute product design transfer activities from late-stage development through commercial launch, ensuring smooth handover into manufacturing.
• Coordinate process transfers from Research and Development to internal or external manufacturing sites and closely track project milestones and deliverables.
• Collaborate cross-functionally with Operations, Development, Regulatory, and Project teams to align on manufacturability, quality, and cost objectives for new products.
• Document and integrate end-to-end manufacturing requirements and best practices, including scalability and design-for-manufacturability considerations, into transfer projects.
• Apply project management methodologies to plan and execute transfer activities, monitor progress, troubleshoot issues, and support the evaluation and implementation of new tools and technologies.
• Support process validation readiness by gathering and organizing required documentation and partnering with Validation Engineers to ensure compliance with validation requirements.
• Actively participate in training and mentorship activities to help build technical excellence within the design transfer team.
• Ensure all processes and activities are conducted safely and in strict adherence to current Good Manufacturing Practices (cGMP), local and international regulations, and internal quality management system standards.
• Assist with audit readiness by collecting, organizing, and maintaining documentation and by supporting investigations and corrective actions related to non-compliance events, such as nonconformance reports.
• Stay current with relevant regulations and internal standards to help maintain ongoing compliance in manufacturing operations.
• Learn and apply basic Lean principles and structured problem-solving methodologies, such as Five Whys and Fishbone diagrams, to identify and eliminate process inefficiencies.
• Use statistical tools and software, such as Minitab, to analyze process data, assess risks, and develop actionable plans for process improvements.
• Develop, standardize, and maintain procedures and documentation for manufacturing processes to support consistency, compliance, and continuous improvement.
• Apply scientific methods and principles to process transfer tasks, focusing on documenting and incorporating design and manufacturing elements that support a design-for-manufacturability approach.
• Contribute to the understanding and optimization of end-to-end production processes for assays and reagents, including formulation, filling, and packaging operations.
• Produce clear, accurate, and comprehensive technical reports and documentation to support design transfer, validation, and regulatory needs.
• Manage multiple low-complexity assignments simultaneously, prioritize tasks effectively, and meet project timelines in a matrixed environment.
• Collaborate effectively across multiple functions, anticipate team needs, and contribute positively to a culture of teamwork, quality, and continuous improvement.

• Bachelor's or Master's degree in a Life Sciences discipline (such as Biology, Chemistry, Biochemistry, Physiology) or in an Engineering discipline (such as Biomedical or Chemical Engineering).
• Minimum of 1 year of directly relevant work experience, preferably within the pharmaceutical, biotechnology, or medical devices industry.
• Experience working in a GMP or otherwise regulated manufacturing environment.
• Foundational knowledge of applying scientific methods and principles to process transfer and design-for-manufacturability activities.
• Basic understanding of end-to-end production processes for assays and reagents, including formulation, filling, and packaging.
• Basic knowledge of Lean principles and their application to process improvement.
• Proven ability to strictly follow standard operating procedures, operational procedures, and quality protocols to ensure compliance and data integrity.
• Excellent stakeholder management, communication, and project coordination skills, with the ability to work effectively in cross-functional teams.
• Strong organizational, critical thinking, and problem-solving abilities, with the capacity to manage multiple low-complexity assignments and meet project deadlines.
• Advanced technical writing skills, with the ability to produce clear, accurate, and detailed technical reports and documentation.
• Strong teamwork ethic and exceptional interpersonal skills, with the ability to collaborate across functions, anticipate team needs, and operate effectively within a matrix organization.

• Experience in the pharmaceutical, biotechnology, or medical device sectors, particularly in technical transfer or manufacturing support roles.
• Familiarity with Six Sigma methodologies and their use in process optimization and problem solving.
• Experience applying Lean tools and structured problem-solving techniques, such as Five Whys and Fishbone diagrams, to identify root causes and drive improvements.
• Experience using statistical tools and software, such as Minitab, to analyze process data, quantify risks, and support data-driven decision making.
• Knowledge of current Good Manufacturing Practices (cGMP) and quality management system requirements in a regulated environment.
• Experience supporting audits, nonconformance investigations, and implementation of corrective actions.
• Comfort working within a matrixed organization and collaborating with diverse technical and non-technical stakeholders.

This is an onsite role within a regulated manufacturing operations environment focused on tissue diagnostics, assays, and reagent production. You will work closely with cross-functional teams including Operations, Development, Regulatory, Validation, and Project Management, often in a matrix structure that encourages collaboration and knowledge sharing. The setting follows cGMP and internal quality management system standards, with a strong emphasis on safety, documentation, and process discipline. Work involves both office-based tasks, such as project coordination, data analysis, and technical writing, and time spent in manufacturing or laboratory areas where adherence to standard operating procedures and appropriate gowning or protective attire is required. The environment supports continuous learning and application of Lean and statistical tools, with access to software such as Minitab and other standard office and technical systems. Working hours typically follow standard business schedules, with flexibility as needed to meet project milestones and support key transfer and validation activities.

Job Type & Location

This is a Contract position based out of Oro Valley, AZ.

The pay range for this position is $30.00 - $32.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Oro Valley,AZ.

This position is anticipated to close on May 8, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.