The Manufacturing Technical Transfer Lead (contractor) plays a pivotal role in facilitating the seamless transition of RUO and Clinical products from development to manufacturing to ensure the successful transfer of products, processes, and technologies. This role is a laboratory position that ensures that all transfers meet quality, cost, and timeline objectives while complying with GMP, ISO, and regulatory standards. Responsibilities include planning and managing technology transfers, preparing and maintaining documentation, pilot manufacturing, and supporting validation activities such as IQ/OQ/PQ. The specialist responds to cross-functional teams-including R&D, Quality, Regulatory, and Operations-to align requirements, troubleshoot technical issues, and implement corrective actions. Additionally, the role involves developing and driving continuous improvement initiatives to optimize processes and reduce costs.
Core Responsibilities- Execute technology transfer initiatives, ensuring timely commercialization of new products and efficient scale-up of existing products.
- Contribute to project oversite, managing all technical components to meet key deliverables and deadlines.
- Serve as a technical authority in cross-functional meetings, representing Manufacturing and Operations interests and providing expert guidance.
- Design and execute experiments for troubleshooting and for enhancing process efficiency, robustness, scalability, and continuous improvement.
- Collaborate with Product Development to define material and manufacturing process specifications, in-process controls, and final product quality acceptance criteria.
- Generate pilot kit build and finalize manufacturing documents and SOPs.
- Act as a subject matter expert in resolving complex production issues, including process failures, equipment malfunctions, and material changes.
- Prepare, review, and maintain technical documentation such as protocols, reports, batch records, and change management requests.
- Support the adoption and maintenance of electronic batch records and ensure record-keeping in compliance with cGMP and regulatory standards.
- Mentor and provide technical support and training to manufacturing and quality control staff, fostering knowledge transfer and best practices.
- Drive operational excellence by leading or participating in initiatives focused on process improvement and efficiency gains.
- Act as a liaison between R&D, Manufacturing, and Quality teams to ensure alignment and effective communication.
Required Qualifications- Bachelor's or Master's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Chemical Engineering, or a related discipline.
- 5-7 years of relevant industry experience in pharmaceutical manufacturing, technology transfer, or process development.
- Demonstrated expertise in reagent manufacturing, process optimization, and technology transfer within the life sciences or clinical diagnostics sector.
Preferred Skills and Attributes- Hands-on experience with molecular biology techniques (e.g., PCR, sequencing, ELISA), and the handling of oligonucleotides and proteins.
- Proficiency in experimental design, data analysis, and the use of statistical and visualization tools.
- Strong understanding of cGMP, FDA regulations, ISO 13485, QMS, and design control principles.
- Experience with electronic batch records, LIMS, and process monitoring systems.
- Familiarity with automation, robotics, laboratory instrumentation, and analytical equipment.
- Excellent technical writing, organizational, and communication skills, with the ability to present complex data to diverse audiences.
- Proven ability to manage multiple projects, prioritize tasks, and meet tight deadlines.
- Strong collaborative skills, with experience in cross-functional teams and engaging with external partners or vendors.
- High level of initiative, independent problem-solving ability, and sound judgment in recommending solutions.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to stay current with scientific advancements and industry trends in process technologies.
- Physical capability to move within office and lab environments and occasionally lift up to 25 lbs.
The base salary range for this full-time position is $55/hour - $65/hour. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted.
