Executive Director of Quality Control

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 Executive Director of Quality Control for Gene Therapy provide technical, operational and strategic leadership and expertise in analytical methods development, transfer, qualification and validation for Gene Therapy products.

Here Is What You Will Be Doing:

· Maintain a broad, flexible and strategic view of the AD/QC function and support.

· Provide strategic/tactical direction to all related department operations.

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

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

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

· Act as the primary AD/QC contact with the R&D testing groups for method development and transfer into non-GMP and GMP testing sites for Gene Therapy assets.

· Act as the primary Analytical and QC SME lead to support regulatory filings and regulatory authorities’ interactions.

· Lead the authoring of technical reports and CMC sections for regulatory filings Will provide technical content relevant to the analytical CMC sections of regulatory documents that support regulatory filings in US and ex-US

· Direct the design, development, transfer and qualification/validation of late stage gene therapy manufacturing release and characterization methods for AAV based Gene Therapy products.

· Responsible for all the methods developed and used for process characterization and process validation.

· Lead efforts to design and implement methods for the physicochemical characterization of AAV gene therapy/gene editing products.

· Lead and support tech transfer of analytical methods to internal and external quality, development and manufacturing organizations.

· Plan and direct the development of novel analytical studies and strategies for characterization of AAV gene therapy products.

· Responsible for the development, generation and review of Certificates of Analysis for AAV based products

· Oversees the approval of all specifications and testing procedures and responsible for the stability program oversight and expiry setting.

· Provide SME oversight through Analytical & QC testing record review, method deviation assessment, OOO’s/OOT’s, and ultimately batch disposition.

· Oversee CDMO and CRO method development operations.

· Will be responsible for setting up future analytical development laboratory, Quality Control laboratory and the associated hiring/developing.

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 Molecular Biology, Virology, Analytical Chemistry, Biochemistry or related discipline and a minimum of 12+ years of industry experience in gene therapy or biopharmaceutical related experience.

· Experience with analytical development for cell and AAV gene therapies is a strong plus

· Experience in molecular biology aspects and gene therapy/vaccines analytical aspects is required

· Experience in all stages of analytical development and product characterization from preclinical through product licensure, including intra- and inter-company technology transfers, CRO/CDMO management, and the evaluation of novel analytical technologies

· Proficiency streamlining the generation, review, and approval of test methods, development reports, qualification reports, stability protocols, and product characterization studies in support of technology transfers and IND/IMPD/BLA/MAA filings

· Fluency with global regulatory guidelines and requirements for advanced therapy medicinal products

· Fluency in the design and interpretation of accelerated and real-time drug product stability programs including forced degradation

· Demonstrated expertise with methods and instrumentation for ddPCR, qPCR

· Demonstrated expertise and hands-on experience with the development of potency assays and knowledge of infectivity methods for viral vector products

· Experience across a broad range of cellular, genomic, proteonomic, metabolomic, and biomolecular analytical methodologies including compendial methods, FACS, NGS, cell-based potency assays, HPLC, and mass spectrometry

· Proven leadership experience and people management skills

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

· Minimum 8-year people management experience with analytical SMEs

· 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

· In-depth knowledge of FDA, EMA, GMP, GCP and ICH regulatory requirements

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.