Passage Bio is seeking a motivated and experienced Associate Director Manufacturing Operations, Gene Therapy to provide technical and operational leadership and expertise in manufacturing operations of Gene Therapy products.

Responsibilities:

·         Ensure the GMP manufacture and supply of high-quality gene therapy products to support early and late stage clinical product development.

·         Act as the primary contact with the CMO to ensure effective collaborations

·         Effectively represent the company in interactions with the CMOs and affiliates.

·         Coordinate conference calls, meeting, event logistics and interactions, schedule and prepare agendas and minutes for key project meetings with external CMO partners and internal stakeholders.

·         Establish outsourcing plans, negotiate contracts and statements of work and provide management oversight to outsourcing activities including budgeting, invoicing and financial reporting.

·         Generate, draft/format and negotiate Project Orders/Statement of Work documents. 

·         Facilitate and follow internal contract review and approval process with external legal counsel, sign-off authority and relevant internal teams.

·         Administer the Project Orders/SOW tracking and record keeping procedures and tools.

·         Schedule and coordinate quarterly CMO Joint Steering Committee Meetings.

·         Maintain CMO calendar, including scheduling key meetings and major operations activities.

·         Provide coordination support to the Processl Development, Manufacturing and Quality team

·         Responsible for the day-today communications with the CMO on downstream process issues and plans.

·         Ensure CMO network supplies high quality gene therapy products for clinical trials by providing oversight through material orders; equipment orders and analytical testing supplies orders

·         Assist with the day to day and short term planning activities at the CMO

·         Oversee CMO supply chain including critical raw materials including DNA plasmids, mammalian-based production cell lines, and cell banks.

·         Partner with Quality functions (Quality Assurance/Quality Control, Qualified Persons, and CMO Quality organizations) to ensure timely and appropriate batch disposition.

·         Partner with Financial planning and Financial controlling to establish manufacturing budgets and financial controls

·         Communicate routine production manufacturing status to company stakeholders.

 

Requirements:

·         BS/MS in a scientific field of study with 8+ years of relevant experience working in Manufacturing/Contract Manufacturing in the Biopharmaceutical/ biotech industry

·         Background in Chemical Engineering, Chemistry, Life Sciences is preferred.

·         Biologics experience required with AAV Gene Therapy products is preferred

·         Technical and regulatory understanding of GMP biologics manufacturing and supply chain, as well as applicable international regulations and standards in all phases of product development and commercialization

·         Strong collaboration and communication, and organizational skills required

·         Experience working with and managing third party contractors and vendors

·         Proven ability to work independently, leadership aptitude and good people skills with the desire and ability to work in a fast-paced, start-up environment

·         Excellent written and verbal communication skills

·         Knowledge of FDA, EMA, GMP, GCP and ICH regulatory requirements

·         Experience with external manufacturing financials, Purchase Order and Invoicing systems is preferred

·         Experience with CMO contracting is a plus

Passage Bio is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled