Senior Manager/Associate Director, Planning & CMC Project Management

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 Senior Manager/Associate Director, Planning & CMC Project Management Gene Therapy to support the tactical and operational aspects of novel CNS Monogenic Gene Therapy at all stages of pre-clinical and clinical development.

Here Is What You Will Be Doing:

Responsible for all activities related to managing and planning the overall supply chain, inventories, clinical supplies of Gene Therapy clinical candidates for domestic and international distribution from Bulk Drug Product to Patient delivery from plasmids to delivery to the patient.
Responsible for the overall supply chain planning of critical materials, plasmid production, drug substance, and drug product supply based on the evolving clinical needs and coordinate the overall portfolio supply relative to the clinical demand.
Develop and lead the Clinical Supply Planning function and the associated processes and procedures.
Provide technical, project management support to the internal development, CMC, clinical, and project management operations group
Plan and coordinate the external CRO/CMO activities and coordinate release and product supply and expiry.
Responsible for projections and forecasting of drug substance, drug product, and finished product inventories and supplies.
Plan and coordinate necessary CMC projects, studies, and activities leading to manufacturing and quality operations
Liaison with internal functions such as Quality Assurance, Clinical Operations, Regulatory Affairs, Project Management, and CMC & Technical Operations functions.

Here Is What You Will Bring To The Table:

Bachelors degree in a scientific field of study with a minimum of 6 years of relevant experience working in the Biopharmaceutical industry.
Background in Chemical Engineering, Chemistry, Life Sciences is preferred.
Demonstrated experience with clinical supply management planning, labeling, packaging, and distribution.
Proven track record of supply chain planning, materials/inventory management, and business process facilitation
Experience in clinical and/or commercial supply chain management of gene therapy products is preferred.
In-depth knowledge of FDA, EMA, GMP, GCP, and ICH regulatory requirements
Excellent written and oral communication skills
Ability to operate in a fast-paced, multi-disciplinary environment

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.