Bio-Techne · 4 hours ago
Technical Transfer Engineer
San Marcos, CA
Full-time
Onsite
Mid, Senior Level
$73K/yr - $120K/yr
3+ years expBio-Techne is a company focused on enabling cutting-edge research in Life Sciences and Clinical Diagnostics. They are seeking a Technical Transfer Engineer responsible for transforming diagnostic products into manufacturable processes, ensuring compliance and operational efficiency through close collaboration with various departments.
BiotechnologyGeneticsManufacturingMedicalMedical Device
Responsibilities
Translate R&D development work into clear, detailed, and compliant work instructions, batch records, formulation instructions, and work instructions
Ensure all operational documentation reflects customer product design requirements, performance specifications, and regulatory constraints
Identify manufacturability gaps early and collaborate with R&D to refine processes for operational efficiency and robustness
Lead the tech transfer process of new products and processes from development into manufacturing
Develop comprehensive tech transfer packages including process flows, equipment needs, critical parameters, and quality controls
Support training of manufacturing personnel on new SOPs, workflows, and product-specific handling requirements
Support engineering runs, pilot lots, OQ/PQ and initial production batches to confirm documentation accuracy and process readiness
Create standardized templates and documentation frameworks to streamline future tech transfers
Define critical process parameters, in-process controls, and acceptance criteria in collaboration with R&D and Quality
Ensure all operational documents are optimized for clarity, usability, and compliance
Serve as the operational bridge between R&D, Manufacturing, Quality Assurance, Quality Control, and Program Management
Participate in customer meetings to clarify design intent, operational constraints, and documentation expectations
Provide input on project timelines, resource planning, and manufacturability considerations
Author and revise work instructions, batch records, and technical reports in compliance with GMP and ISO standards
Support internal and external audits on tech transfer by providing accurate, up-to-date operational documentation
Maintain document control discipline, ensuring revisions, approvals, and change controls are properly executed
Identify opportunities to improve process clarity, reduce variability, and enhance operational efficiency
Drive updates to tech transfer SOPs and new product batch records based on production feedback, deviations, and CAPA outcomes
Contribute to the development of best practices for documentation, tech transfer, and operational readiness
Qualification
Required
Bachelor's degree in Biochemistry, Molecular Biology, Chemistry, Biomedical Engineering, or related field
3–7 years of experience in diagnostics, IVD manufacturing, or biotech operations
Experience writing SOPs, batch records, or technical manufacturing documentation is strongly preferred
Strong understanding of IVD manufacturing processes, including reagent preparation, filling, lyophilization (if applicable), labeling, and packaging
Experience with statistical tools for assessing process capability and quality control
Familiarity with ISO 13485, GMP/QSR, design control, and risk management (ISO 14971)
Ability to interpret development data, customer requirements, and assay performance characteristics to define operational processes
Exceptional technical writing and documentation skills
Strong attention to detail and commitment to accuracy
Effective communicator who can collaborate across R&D and operations
Organized, proactive, and comfortable managing multiple projects in parallel
Preferred
Experience writing SOPs, batch records, or technical manufacturing documentation is strongly preferred
Background in IVD assay development, reagent formulation, or calibrator/control production is a plus
Benefits
Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield
401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA
Mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more
Employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging
An accrued leave policy with paid holidays, paid time off, and paid parental leave
A culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table
Company
Bio-Techne
Bio-Techne is a supplier of tools for life science research, therapeutic manufacturing, and clinical diagnostics.
1001-5000 employees
H1B Sponsorship
Bio-Techne has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (4)
2022 (9)
2021 (6)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
unknown1989-05-19IPO
Leadership Team
Gary Latham
Chief Technology Officer
Jim Hippel
Executive Vice President and Chief Financial Officer
Recent News
2026-02-05
2026-02-04
Company data provided by crunchbase