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:  

Passage Bio is looking for Director of Bioassays who will lead bioassay development strategies and drive the bioassay development, qualification, and validation to support the company clinical-stage gene therapy programs.  This important leadership role will function as an expert to provide technical guidance to scientists to design the cell-based functional assays to quantify the level of vector transgene expression and the functionality of the transgene products in vitro.  The role calls for close collaboration to work on cross-functional development teams and support regulatory submissions. 

Here Is What You Will Be Doing: 

• Lead and oversee bioassay development and validation activities for cell-based functional assays such as infectivity assay, transgene expression level, and functionality of the expressed proteins.  
• Provide guidance to design, develop, optimize, qualify, validate and transfer cell-based potency assay, enzyme activity assay, and other bioassays to support the release and characterization of AAV gene therapy vectors in conformance with cGxPs.
• Lead and support characterization and comparability studies, and support establishment of control strategy for late-stage programs.
• Partner with the stakeholders and SMEs to align on priorities, resources, support, and expertise as required.
• Build up bioassay team and develop talents, and promote team work orientated initiatives and operational excellence.

  

 Here Is What You Bring To The Table: 

  

·        Ph.D. in Biological Sciences, Cell Biology or Molecular Biology and 8+ years of related experience, or BS/MS in the scientific field of study with 12+ years of relevant experience working.

·        5+ years’ experience in managing direct reports as well as staff and activities in the network and matrix environment.

·        Demonstrated ability to lead programs and/or projects, ability to influence in a highly technical environment and must have strong communication skills.

·        Direct experience with AAV-based gene therapy, potency assay development and qualification and validation are highly preferred.

·        Excellent communication skills and the ability to work effectively as a member of a cross-functional team.

  

  

 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 1 pm 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