Passage Bio is an exciting, fast-paced, rapidly growing gene therapy company headquartered in Philadelphia, PA. Our portfolio of rare monogenic CNS gene therapies is the result of an exclusive collaboration with the renowned Gene Therapy Program (GTP) at the University of Pennsylvania (Penn) that provided Passage Bio with 17 gene therapy candidates developed in the lab of gene therapy pioneer Dr. James Wilson. Passage Bio is on a mission to provide life-transforming gene therapies for patients with rare monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve.
The Role:
The process development upstream team is seeking a highly motivated and innovative process scientist. The successful applicant will have experience in laboratory research, and a desire to continue in a laboratory-focused role. This individual will be responsible for planning and executing lab-scale cell culture experiments, developing robust, efficient, scalable cell culture processes, participating in the manufacture of cGMP clinical bulks, and transferring processes to clinical or commercial manufacturing facilities for AAV-based gene therapy drug products. The Scientist will be responsible for working with fellow scientists to develop robust, efficient, scalable strategies for improving process performance. The role will also be responsible for providing technical support to technology transfer, scale up, and internal/external manufacturing, as well as regulatory filings as needed.
Here Is What You Will Be Doing:
- Working in a highly collaborative environment, the successful candidate in this laboratory-based position will:
- 70% Design and execute lab experiment to develop efficient, robust, scalable and cost-effective upstream process
- Independently develop, design, and conduct viral vector production experiments and evaluate new technologies to increase product yield and process understanding using design of experiment.
- Develop, maintain, and demonstrate advanced knowledge of principals and techniques in cell culture, bioreactor operation, viral vector production, process intensification and media development.
- Lead development of study design, optimization of production process conditions, media screening and perform troubleshooting experiments and communicate findings with appropriate working groups.
- Lead scale-up activities to implement a manufacturing process based on applied cell culture knowledge.
- Extensive understanding of analytical tools and calculations such as cell counting, oxygen uptake rates, metabolite consumption rates, viral vector titer and product quality assessments.
- 20% Analyze and interprets process and analytical data to make sound decisions. Maintain accurate and complete lab notebooks. Authoring technical reports, data summaries, tech transfer reports. Present results in internal meetings or external conferences.
- 10% Interact with internal and external partners, may represent functional area on cross functional teams. Support downstream process tech transfer, scale-up, clinical and commercial manufacturing as needed. Support regulatory filings. Leverage personal strength, knowledge and experience to mentor colleagues or junior scientists.
- Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered. Proof of vaccination required.
Here Is What You Will Bring To The Table:
· Ph.D. in Chemical/Biochemical Engineering, Biological Sciences, or a related scientific discipline, with 5-8 years of industry experience or relevant academic experience.
· Experience with high throughput technologies as applied to upstream process development is preferred
· Advanced knowledge of principles and techniques in viral vector production is preferred.
· Experience with process technology transfers and performing gap analyses and risk assessments.
· Strong understanding of the principles of Quality by Design and ability to apply DOE to upstream development. Knowledge of statistical methods for DOE design and data analysis (e.g. JMP) is highly desirable
· Expertise in technical report writing, and ability to draft manuscripts for external publications.
· Knowledge of analytical methods to support product and process characterization is preferred
· Experience with upstream process development of biological products, such as viral vectors, vaccine, recombinant proteins is preferred
Here’s What We’ll Bring To The Table · Up to $270 for public transportation and parking · Highly competitive healthcare coverage including: medical offered (HMO/PPO), dental, and vision offered · Summer hours from May to September with 1pm office closure* · Flexible Spending Accounts for medical expenses and dependent care expenses · 12 weeks of 100% paid parental leave for all new parents within 6 month · 401k (traditional and Roth offered) with 5% match · A suite of Passage Bio paid insurance coverage, including: life insurance, short-term and long-term disability · Voluntary legal assistance as well as pet, liability, critical illness, hospital indemnity and accident assistance · 20 days’ vacation and Unlimited sick time per year, and 14 company paid holidays (includes 2 floating holidays in addition to a discretionary winter shut down)
Passage Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Passage Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.