External Manufacturing Lead

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Date: Nov 16, 2023

Location: Philadelphia, PA, US, 19104

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. 

 

We don’t follow footsteps. We create the path.

 

 

 

Primary Duties

The External Manufacturing Lead will manage the day-to-day operations of Spark’s Contract Development and Manufacturing Organizations (CDMOs) that provide plasmids, cell banks, devices, drug substance, drug product formulation and aseptic filling, and packaging labeling services for drug substance/drug product intended for commercial and/or clinical distribution.  This role will be an external-facing role and requires a person who acts in a respectful and professional manner, demonstrating Spark’s values and in accordance with Spark’s code of conduct.

 

Ensures, in collaboration with the Supply Chain, CMC Program Management, and Tech Transfer teams, the timely routing and review of external manufacturing project/program deliverables including: manufacturing records, standard operating procedures, and other documentation needed to successfully execute required clinical and commercial activities. The incumbent will manage cross-functional teams and programs across sites, with a lighter touch during tech transfer moving into a heavier touchpoint for routine /commercial production. This role will be responsible for managing quality records and other activities required for release and delivery of materials per the supply plan.

 

Responsibilities

  • May act as primary point of contact for CDMO program management. Responsible for managing the day-to-day deliverables associated with technology transfer execution associated with the SOW and project plans.

  • Interfaces between the Spark technology transfer teams and the CDMO. Responsible for ensuring protocols, batch records, quality records, and other technical documents are managed according to the project schedule.

  • May lead internal team meetings to ensure alignment and action towards deliverables to achieve efficient routine Spark-vendor meetings.

  • Interfaces frequently with the Manufacturing Operations, Quality Control, Quality Assurance, Clinical, Regulatory, and Supply Chain teams to ensure expectations and timelines are well-communicated to facilitate efficient and seamless hand-offs in manufacturing and testing activities.

  • Responsible for initiating, authoring, and managing the on-time closure of quality records associated with external manufacturing of cell banks, plasmids, drug substance (commercial), drug product, and diluent fill and packaging.

  • Responsible for interfacing with Spark’s partners and providing information as requested to support change controls, regulatory requests, and batch disposition in accordance with partner agreements.

  • Provides metrics and performance data as required for reporting.

  • Provides technical expertise for drug substance and drug product manufacturing issues that arise as part of routine manufacturing, including leading the Spark troubleshooting efforts and technical evaluation of deviations that arise during manufacture. Enlists assistance from SMEs (i.e. Tech Dev / MS&T as needed).

  • Provides person-in-plant support during drug substance and product manufacturing activities.

  • Assists with the preparation, review, and approval of regulatory documents such as INDs, BLAs, CBE-30s, briefing documents, etc.

  • Supports on site (internal or external) health authority inspections; quality audits; inspection/audit responses and CAPAs

 

Education and Experience Requirements

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  • BS degree in a science or engineering discipline.

  • 5-7years’ experience in the pharmaceutical / biotechnology industry. Gene therapy experience is a plus.

  • Knowledge of drug substance and drug product manufacture (equipment and processes).

  • Strong understanding of GXP compliance as well as USP, EP, ICH, and FDA guidelines.

  • Must have experience with Regulatory submissions and inspections.

  • Must have experience working in a GMP cleanroom environment.

 

This position is expected to be primarily campus based (more than 80% of time in office).

 

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.  The base salary range for this position is currently from $109,200 to $163,800. 

 

 

  

 

 

 

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.


Nearest Major Market: Philadelphia