Hiring company: Kite Pharma
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?
Kite is seeking a highly motivated individual with biotechnology experience to work on innovative T cell therapies for cancer treatment. Part of the Site Manufacturing Sciences and Technology, the Manager, Process Engineering, is a key leadership role within Kite Pharma’s Process Development and Technical Operations. As a Manager you will provide technical and organizational leadership support to the commercial manufacturing for cell therapy. As a member of Site MSAT Leadership Team you are expected to oversee MSAT team’s responsibilities for product/process response and investigations, project management, and process improvements. The ideal candidate must have experience in cell therapy and/or biologics, GMP manufacturing and excellent understanding of regulations.
Responsibilities (include but are not limited to):
- Manage team of process scientists and engineers in support of commercial manufacturing process
- Build a high performing team, provide necessary training and ongoing mentoring and recognition
of direct staff, including performance reviews according to Kite standards - Develop and lead aspects of the MSAT team’s contribution towards:
- Authorship of process and product impact assessments
- Lead cross functional teams to perform root-cause investigations and deviation resolution
- Monitoring process performance through data-based trending
- Performing data-based deviation resolution and improvement projects
- Supporting manufacturing through risk assessments and remediation measures
- Collaboration with technical and operational stakeholders, write and review SOPs, batch records, and other operational related documents as needed
- Act as communication channel between global organizations and site manufacturing and as a process expert for site leadership councils
- Lead and coach team members to execute continuous improvement projects
- Provide leadership, design studies, and author protocols and reports for process understanding/characterization and validation studies
- Support evaluation of new technology, process automation, and IT infrastructure projects
- Support site change management and process related CAPAs
- Support regulatory inspections and projects for regulatory commitments
- Act as sending unit or receiving lead for technology transfers and support new product introductions
- Experienced understanding of process development, validation, and Lifecycle management to support comparability studies, process validation, and licensure changes
- Conducts technical and scientific training
- Additional duties as assigned
- These duties can be delegated to designated deputies of a satisfactory qualification level as needed
Basic Requirements:
- PhD in Biochemical Engineering, Biotechnology or Life Sciences with 3+ years of biotech experience
- Masters Degree in Biochemical Engineering, Biotechnology or Life Sciences with 5+ years of biotech experience
- Bachelors Degree in Biochemical Engineering, Biotechnology or Life Sciences with 7+ years of biotech experience
- High School Diploma with emphasis in Biochemical Engineering, Biotechnology or Life Sciences with 11+ years of biotech experience
Preferred Qualifications:
- Cell therapy experience
- Knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development
- Some experience with people leadership
- Expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Experience interacting with regulators and inspectors as part of site inspections and audits preferred
- Experience with leading investigations, writing, deviation reports, change controls, and corrective actions
- Ability to share complex principles of knowledge to others (team member, stakeholder, external, or inspection) along with strong technical writing abilities
- Support leadership in providing vision to team, determining objectives for group. Plan schedules, resources, and arranges team activities in accomplishing objectives
- Experience supporting cross functional teams to obtain project deliverables
- Knowledge of scientific and engineering principles
- Knowledge of data management tools and statistical process controls
- Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus
- Flexible, resilient, and self-motivated; willing to accept temporary responsibilities outside of initial job description
Are you a problem solver and do you have a continuous improvement mindset? Be sure to include this, also.
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Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.