Technical Transfer Specialist - Manufacturing Operations

• 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.

• 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 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.

• 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.

• 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.

Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.