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 Downstream Process Development will be accountable to provide Lonza Cell & Gene Therapy customers with best-in-class viral vector downstream process development and technology transfer activities from Lonza’s new state-of-the-art facility in Pearland, TX. This senior role will be responsible for oversight and management of all vector Downstream Development activities, including chromatographic purification, deadend filtration, UF/DF, centrifugation, product formulation, process scale-up and optimization activities, and all technical documentation impacted by the Downstream Team. The Head of DS PD will drive downstream rAd5 and rAAV Process Characterization initiatives using DOE and support process Validation/PPQ. Leadership responsibilities include supervision and mentorship, hiring and training, troubleshooting and occasional hands-on work, as well as serving as viral vector SME for investigations, customer meetings and business development as needed. Team member will interface closely with other departments (MSAT, GMP Operations, QC, Program Management, QA)
The successful candidate will have demonstrated prior industry experience developing viral vector downstream purification, and will serve as senior leadership for the downstream process development and process tech transfer team, accountable for the full process development project lifecycle from client to PD to Production floor. Ability to manage and prioritize several projects in parallel is key. Ensures schedules and performance requirements are met.
Primary Role Responsibilities
- Oversight, scheduling, planning and reviewing of new Ad5, AAV, lentivirus and other vector process development and tech transfer experiments in the PD lab related to all downstream processes and in-process analytics, to include process optimization and problem-solving processes and equipment. Uses DOE when needed.
- Critically analyzes processes for improved recoveries, through-put and scalability, and utilizes background and expertise in downstream purification, and product formulation technologies to establish and optimize new processes for incorporation into viral product manufacturing.
- Accountable for analysis of data from downstream, 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 downstream viral vector Process Characterization activities.
- Serves as viral vector SME for proposals, new client development and for downstream team to design and execute study plan; represents Lonza C> in technical presentations and reports and industry conferences
- Accountable for meeting timelines and achieving timely deliverables, and shaping communication of 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 as an SME for downstream 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 bioprocess experience in an FDA-regulated environment. Outstanding technical writing and oral communications skills are mandatory. Candidates without a PhD may be considered based on prior pharma/CDMO experience.
- Must have thorough knowledge of cGMP requirements and facilities to put safety and product quality first.
- Must have formal, demonstrable understanding of tech transfer and scale-up using chromatography skids, UF/DF, of formulation development through pilot-scale facilities. Solid understanding of and experience with in-process and final product analytics for product quality monitoring is a must.
- Demonstrated leadership and prioritization abilities; ability to motivate, deliver and to excel in a team setting are essential for this leadership position.
- Prior experience with PD automation such as TECAN is desirable, as is prior experience on the manufacturing floor.
- Prior experience in late-stage clinical or commercial product development of virus or protein is highly desirable.
A portion of work is 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.
Doctorate: Biomedical Engineering
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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