At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
We strive to be the leading supplier using science and technology to improve the quality of life.
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?
Job Description Summary
The Head of Upstream Process Development will be accountable to provide Lonza Cell & Gene Therapy customers with best-in-class process development and technology transfer services from Lonza’s new state-of-the-art facility in Pearland, TX. This senior role will be responsible for high-performing upstream viral vector process development Team, with functions including generation and oversight of design (DOE), development, data analysis, scale-up, internal tech transfer, process optimization and all related documentation, for Upstream Development activities, including cell line development, banking, cell culture, viral vector production, recovery through generation of column load material, with of focus on AAV production. Accountable to drive upstream AAV and Ad5 Process Characterization activities. Leadership responsibilities include supervision and mentorship, hiring and training, troubleshooting and occasional hands-on work, as well as serving as viral development and production SME for investigations, customer meetings and business development as needed. Team member will interface closely with other departments (MSAT, GMP Operations, Quality Control, Program Management, Quality Assurance).
The successful candidate will have industry experience with viral vector development (preferably AAV) and serve as the department lead for client-specific upstream batch viral process development and process tech transfer (from client and to Production group). Ability to manage and prioritize several projects in parallel is key. Ensures schedules, and performance requirements are met.
Primary Role Responsibilities
- Oversight, scheduling and planning of new AAV, Ad5, Lentivirus and other process development and tech transfer activities in the PD lab related to all upstream processes, to include process optimization and problem-solving processes and equipment.
- Critically analyzes processes for improved productivity, through-put and scalability, and utilizes background and expertise in upstream viral production, harvest and recovery technologies to establish and optimize new processes for incorporation into viral product manufacturing.
- Accountable for upstream data analysis, generation of reports and tech transfer documentation (BFD, PPL, etc) as well as oversight on new development protocols, and IP disclosures when applicable. Technical writing to include SOPs, PD batch records etc.
- Drives upstream viral Process Characterization including C&E and Risk analyses, FMEA, and DOE to provide process characterization package.
- Serves as viral vector development and production SME for proposals, new client development and for upstream team to design and execute study plan. Represents Lonza process development in publications and presentations at conferences.
- Accountable for meeting timelines and achieving timely deliverables, and clearly communicating results to clients and internal cross-functional teams.
Closely interacts internally with other departments principally Manufacturing Sciences and Technology, GMP operations, and Program Management for PD functions, and externally with vendors to identify and secure new technology.
Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
Is knowledgeable and complies with all pertinent safety policies, rules and regulations. Ensures that all team members comply with safety rules and regulations.
Provides appropriate coaching and performance feedback to direct reports and assures that team members are being developed.
Skill and/or Education Requirements
PhD degree in biochemical engineering, biosciences, virology or related discipline plus 10+ years of related bioprocess experience in an FDA-regulated environment. Candidates without a PhD may be considered based on prior experience in pharma/CDMO. Preferential consideration given to candidates with direct process development and/or manufacturing experience using viral vectors, preferably AAV.
- Outstanding technical writing and oral communications skills are mandatory.
- Must have thorough knowledge of cGMP requirements and facilities to put safety and product quality first
- Demonstrated experience with viral vector production process scale-up (AAV preferred) with a solid understanding of STR, clarification/depth filtration, UF/DF including hands-on expertise with scalable bio-production platforms and equipment.
- Demonstrated skills in problem-solving and proposing solutions
- Demonstrated ability to prioritize projects and manage time of self and reports, including the ability to meet immutable deadlines
- Independent work skills; strong work ethic; delegating skills; ability to motivate and to excel in a team setting are essential for this leadership position
Some work may be done in the laboratory environment. While working in the laboratory environment appropriate gowning, including safety equipment, is required as denoted for the designated area (i.e. lab coat, gloves, safety glasses). Some lifting of items up to 20 pounds. Exposure to potentially hazardous chemicals is possible. Eyestrain and/or repetitive motion symptoms may occur due to use of the computer. Occasional extended daily or weekend hours may be required.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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