Job details
Job type full-time
Full job description
Job description
Are you ready to fill a key technical role contributing to process improvements that impact patient outcomes? come join us in our mission to cure cancer!
Kite is seeking a highly motivated individual with process development and tech transfer experience to join our expanding global manufacturing science & technology (msat) teamAs an associate director, you will lead the tech transfer of kite’s pipeline products from process development to manufacturing and facilitate strategic project execution across multiple global production sitesThe qualified candidate will be the primary interface with both internal and external technical teams, provide project leadership and project management for transfer of product, process, analytical methods and vector knowledge and materials from the process development team or sending site to the receiving unitYou will oversee all required activities for from kick off of tech transfer activities with process development/design for a clinical project to the realization of commercial launch and resupply campaignsPrimary responsibility will be to lead the established tech transfer process from process development for clinical and commercial projectsSecondary support will be provided for tech transfer of the developed manufacturing process to external manufacturing sites and/or partnershipsAdditionally, you will lead project planning, strategy and authoring of tech transfer plans and reports.
Responsibilities (include but are not limited to):
Lead tech transfer of kite’s pipeline cell therapy and viral vector products from process development to domestic and global manufacturing sites, external partners or joint ventures
Lead global tech transfer and technology from sending to receiving units during various stages of product lifecycle, such as clinical or commercial manufacturing
Lead project planning and strategy through various stage gates from project initiation through bla filing submission and/or routine production post-ppq
Utilize project management methodology to develop high level and detailed schedules and drive tech transfer activities and collaboration
Utilize expertise in process development, cell therapy production and/or biologics operations to resolve technical challenges encountered during tech transfer
Lead cross-functional tech transfer teams, track project status, provide routine updates to steering committee/executive leadership
Identify program gaps and perform risk identification/mitigation and facilitate risk assessments to ensure timely execution of tech transfer
Author tech transfer master plans and tech transfer summary reports
Review and approve process validation master plans, protocols and reports
Basic requirements:
Phd in biochemical engineering, chemical engineering, biotechnology, chemistry, biology with 2+ years of experience or
Ms in biochemical engineering, chemical engineering, biotechnology, chemistry, biology with 8+ years of experience or
Bs in biochemical engineering, chemical engineering, biotechnology, chemistry, biology with 10+ years of experience or
Hs diploma and 14+ years of experience
Preferred qualifications:
Working knowledge of cgmp manufacturing and regulatory regulations and requirements for biologics, pharmaceuticals and medical devices
Extensive biologics process development and/or manufacturing operations is required.
Cell therapy process development experience is a plus.
Cell culture and aseptic processing experience is required
Experienced in project management and project management methodology is a plus
Experience participating or leading tech transfers is required
Knowledge of product lifecycle – product and process development, clinical trials, validation and regulatory submissions, commercial cgmp manufacturing is required
Expertise in industry best practices, guidelines and/or regulations related to process validation (pda/ich/bpog) and boards of health (fda/ich/ema/pics) is desired
Expertise in process validation lifecycle and specifically process performance qualification (ppq) through continuous process validation (cpv) program and pre-approval inspection (pai) is desired
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
Working experience using microsoft project (or similar) to manage schedule slip and redirect efforts to ensure timely project execution is desired
Excellent presentation and communication skills
Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team-based decisions
Self-motivated and willing to accept temporary responsibilities outside of initial job description
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
As part of tech transfer travel may be required
Does this sound like you? if so, please apply today!
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