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 seeking a motivated and experienced Sr. Director Process Development, Gene Therapy to provide technical, operational and strategic leadership, and expertise in the purification development, mid-stream and operations development, tech transfer and manufacturing operations support of rAAV Gene Therapy products.

Here Is What You Will Be Doing:

·        Serve as a Subject Matter Expert (SME) for the development of robust, high performing downtream processes with emphasis on transferability to cGMP manufacturing and supports regulatory filings.

·        Develop robust, scalable, transferable processes for downstream production of rAAV clinical gene therapy vectors.

·        Demonstrate innovative design, development, and execution of process development projects through literature review and scientific teamwork.

·        Responsible for chromatographic and physical separations (TFF) development and bulk drug substance development operations. 

·        Provide tactical direction to all related department operations.

·        Manage all subject matter experts (SMEs) for both internal and external (CDMO) projects in all areas of process development.

·        Act as the primary SME contact with the CDMO to ensure effective development, tech transfer and validation of processes and analytical methods.

·        Support the technology transfer for early stage and late stage gene therapy candidates to CDMO from internal and external partners.

·        Act as the primary CMC contact with the R&D function for rAAV gene therapy preclinical assets.

·        Act as the primary CMC technical lead in regulatory filings and regulatory authorities’ interactions.

·        Direct the design, development, scale-up, and technology transfer of late stage gene therapy manufacturing processes.

·        Direct process and method optimization and development of manufacturing platform across multiple products

·        Responsible for process characterization and validation strategy and execution.

·        Provide SME oversight through batch record review, deviation assessment, batch disposition.

·        Write study development reports, process characterization reports, transfer documents, and regulatory documents.

·        Oversee CDMO development operations.

·        Assist in the generation of project and cost proposals, timelines, and work plans by applying scientific knowledge and project management experience.

·        Author manuscripts and presents results at scientific meetings.

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:

·        A PhD in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant discipline and a minimum of 10 years of progressively responsible experience in gene therapy/vaccines/complex biologics process development roles.

·        Experience with rAAV Gene Therapy products is preferred; experience with plasmid process development is a plus.

·        Regulatory understanding of GMP biologics manufacturing as well as applicable international regulations and standards in all phases of product development and commercialization.

·        Experience writing /prior success filing writing appropriate sections of CTX, NDA, BLA, MAA IND & IMPD documents

·        Proven leadership experience and people management skills

·        Knowledge and experience with process characterization and transfer is essential. Expertise in DOE and statistical analysis of data is a plus.

·        Strong organizational, analytical, and problem-solving skills.

·        Work planning, data analysis, and record keeping skills (with strong attention to detail) will be required.

·        Ability to work in a fast-paced, start-up environment.

·        Strong collaboration and team-building, communication, and organizational skills required.

·        Experience working with and managing third party contractors and vendors.

·        Excellent written and verbal communication skills.

·        Demonstrated experience with scientific and technical writing in regulatory submissions.

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.

·        Monthly Wellness Day

·        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).

 

Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered.  Proof of vaccination required.

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.