Technical Transfer Specialist - Manufacturing Operations

The Fountain Group LLC

Tucson, AZ

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JOB DETAILS

SKILLS

Assays, Best Practices, Biochemistry, Biology, Biomedical Engineering, Biotech and Pharmaceutical, Chemistry, Continuous Improvement, Corporate Compliance, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Data Processing, Data Quality, Documentation, Documentation Standards, GMP (Good Manufacturing Practices), Identify Issues, Interpersonal Skills, Lean Manufacturing, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing Requirements, Manufacturing/Industrial Processes, Matrix Management, Medical Equipment, Mentoring, Minitab, Operations Processes, Physiology, Problem Solving Skills, Process Analysis, Process Management, Process Validation, Product Design, Project Tracking, Project/Program Management, Regulations, Research & Development (R&D), Risk Management, Safety Compliance, Six Sigma, Standard Operating Procedures (SOP), Standards Development, Statistics Software, Support Documentation, Team Player, Technical Support

LOCATION

Tucson, AZ

POSTED

9 days ago

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.

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., Client 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.

REQUIRED QUALIFICATIONS:

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.
Proven ability to strictly follow standard operating procedures (SOPs), operational procedures (OPs), and quality protocols, ensuring compliance and data integrity.
Basic knowledge of Lean principles or familiarity with Six Sigma methodologies is a plus.
Strong teamwork and interpersonal skills, with the ability to effectively collaborate across multiple functions, anticipate team needs, and navigate a matrix organization.

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About the Company

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE

500 to 999 employees

INDUSTRY

Staffing/Employment Agencies

WEBSITE

https://www.thefountaingroup.com/

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