Transfer Specialist

The Transfer Specialist - Reagent Manufacturing supports the introduction of new assays, reagents, and bulk materials for tissue diagnostics 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.

REQUIRED QUALIFICATIONS

--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.
--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).
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 *** (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.

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.