Company Overview:
Prestige Biologics Co., Ltd is a biopharmaceutical CDEMO (Contract Development Engineering Manufacturing Organization) that provides complete solutions to the development and manufacturing requirements in your drug discovery from early stage to product registration and commercialization.
Based on our fully established antibody drug & vaccine manufacturing capabilities, we now offer our upgraded CDMO service, CDEMO in which we provide customized engineering solutions for your manufacturing process in a customized manufacturing suite speed-built with our proprietary technology, ALITA Smart BioFactory™.
Position Overview:
We are seeking a dynamic and experienced Tech Transfer PD(MSAT) Lead Engineer/Senior Lead Engineer to provide high-level technical expertise for the transfer of development processes into GMP manufacturing. The successful candidate will be responsible for working with process teams internally and/ or externally, as well as other departments e.g. manufacturing, engineering, QA, QC, SCM, to ensure smooth technology transfer of processes pertaining to biological drug substances (DS) especially on drug products (DP) processes. He/She shall utilize scientific, engineering, and regulatory expertise to handle technical challenges, and take lead position to resolve any technical issues ahead of or during GMP biopharmaceutical manufacturing. A good team player with collaborative spirit.
Key Responsibilities:
· Technology transfer
- Perform product technology transfer for DS and especially on DP, specifically for mammalian cell culture and purification processes from the Process Development team and/or external customer site to GMP manufacturing site.
- Ensures that all tech transfers into manufacturing operations are controlled and implemented within GMP regulatory guidelines.
- Ensures the availability of relevant SOPs and documentation to enable right first time and on time delivery of customer technology transfer projects.
- To keep abreast of regulatory guidelines to meet GMP compliance.
· Strategic Planning
- Participates in resource and capacity planning for the GMP manufacturing site.
- To liaise with the R&D, PD team (or customer for direct transfer of external processes) to ensure processes for GMP manufacture are robust, scalable, and suitable for the equipment on-site.
· Manufacturing and Engineering Activities
- To have a strong technical understanding in USP, DSP of DS, DP and analytical testing.
- To be familiar with set up and operation of equipment used in bioprocess manufacturing (DP & DS)
- To write and review GMP production reports and related documents to support CMC requirements.
- To review GMP material assessments and bill of materials for use in manufacturing.
- To participate in writing, reviewing process descriptions, equipment SOPs, process change controls, process risk assessments, batch manufacturing records and other documentation relevant to GMP manufacturing.
- To support Manufacturing and Engineering teams with fit assessments/ gap analysis of equipment, facilities, and processes.
- To perform risk assessment and mitigation (both process and safety related) to ensure processes are not adversely impacted.
- To use technical knowledge to lead equipment PQ, process deviation investigations, impact assessments and reports, CAPA and Change Control.
- Develop and review Manufacturing Process Description, Master Production Records and Process Performance Qualification/Process Validation Protocols.
- To write and perform Product Impact Assessment whenever there is a Deviation/Incident
- To collaborate with cross-functional team to investigate and derive the probable root cause due to deviation/incident.
- Support audit activities when necessary.
- To support in specifications developments.
- To support in regulatory inspections such as FDA and EMA inspections from technical perspective.
Qualification
· Educational Qualifications:
- Bachelor degree, Master’s degree or Ph.D in Chemical Engineering, Biochemical Engineering, Biotechnology or equivalent.
- Certifications in GMP and Six Sigma can be advantageous.
· Professional Experience:
- Minimum of 8-10 years of experience in biologics process development or biologics commercial manufacturing.
· Technical Skills:
- In-depth knowledge of process development, scale-up, and transfer of biopharmaceutical processes.
- Strong understanding of GMP regulations and compliance requirements.
- Proficiency in data analysis and interpretation, with the ability to troubleshoot and resolve technical issues.
· Interpersonal Skills
- Excellent team collaboration skills, with the ability to work effectively with cross-functional teams, including manufacturing, engineering, QA, QC, and supply chain management.
- Strong verbal and written communication skills, able to convey complex technical information clearly to different stakeholders.
- Proven problem-solving skills, with a proactive approach to identifying and resolving technical challenges.
