Sr. Engineer / Sr. Scientist & Group Leader– Cell Culture Process Development
The successful candidate in this role will lead the cell culture process development team for JHL Biotech to develop to develop and implement robust manufacturing processes for biological therapeutic proteins. They will use their strong scientific background and leadership in cell culture to ensure that JHL Biotech is a world class leader in CMC development and operations. This person will be very hands-on in the lab and will be accountable for the design, execution, and evaluation of laboratory scale cell culture experiments leading to robust processes suitable for clinical and commercial manufacturing. Responsibilities will also include leading technology transfer and providing technical support for clinical manufacturing as well as document authoring for regulatory submissions. This position will also require direct supervision of one or more reports, and will take leadership roles in collaborative projects with internal and external parties.
- Design, execute and evaluate laboratory-scale cell culture experiments in order to develop robust processes suitable for GMP clinical and commercial manufacturing
- Process development scope includes clone screening in bioreactors, media and feed development, defining optimal ranges for bioreactor operation and control parameters
- Develop phase-appropriate characterization and validation strategies for the developed processes
- Implement sound statistical DOE-based studies for efficient process optimization and characterization
- Seek out, evaluate, and implement new technologies to optimize efficient development of cell culture processes
- Provide direct supervision of one or more junior staff members including defining appropriate work allocation, training on laboratory techniques and procedures, and mentoring of career development
- Develop and maintain necessary process development documentation standards including process development reports, technical transfer reports, and characterization and validation protocols, as well as laboratory equipment data capture and storage.
- Support process transfer into manufacturing and lead process validation at scale
- Write and revise protocols, procedures, reports and other process related documentation as necessary to support GMP manufacturing operations
- Author cell culture sections of regulatory submission documents for world-wide health authorities
Job Qualifications (Education, Certifications, Experience)
- Requires a PhD in Chemical/Biochemical Engineering, Biochemistry, Cell Biology, or related discipline and 5+ years of relevant experience
- Strong Scientific and Engineering expertise developing novel upstream mammalian cell culture processes for the generation of monoclonal antibody and recombinant protein therapeutic products.
- Expertise in optimization of cell culture processes to manipulate product quality characteristics as well as productivity
- Experience with CHO-based expression systems highly desirable
- Extensive hands-on expertise with laboratory procedures and operations including set up and operating shake flasks, lab scale bioreactors and pilot scale bioreactors and associated analytical techniques used for mammalian cell culture processes
- Experience with single use bioreactors (SUBs) highly desirable
- Expertise leading media and feed development, scale-up, technology transfer and process validation activities
- Experience with cGMP’s highly desirable
- Experience authoring IND, CTA, and BLA regulatory documents highly desirable
- Proven record of technical leadership, including the ability to influence, motivate, and drive technical rigor
- Excellent written, oral and organizational skills