Transfer Specialist – Reagent Manufacturing Operations

Job Description

Job Summary:

• The Transfer Specialist – Reagent Manufacturing supports the introduction of new assays, reagents, and bulk materials for tissue diagnostics into client’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.

Duties and 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 Client (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.

Education and Experience:

• Bachelor’s or Master’s degree in a Life Sciences (Biology, Chemistry, Biochemistry, Physiology, etc.) discipline.
• Excellent stakeholder management, communication, and project coordination skills.
• Strong teamwork ethic and exceptional interpersonal skills, with the ability to effectively collaborate across multiple functions, anticipate team needs, and navigate a matrix organization.
• 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.
• Proven ability to strictly follow standard operating procedures (SOPs), operational procedures (OPs), and quality protocols, ensuring compliance and data integrity.

Competencies:

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).

Knowledge, Skills, and Abilities:

• 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.
• Excellent stakeholder management, communication, and project coordination skills are required.
• Strong organizational, critical thinking, and problem-solving abilities, with the capacity to manage multiple low-complexity assignments and meet project deadlines.
• 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.
• Strong organizational, critical thinking, and problem-solving abilities, with the capacity to manage multiple low-complexity assignments and meet project deadlines.