External Manufacturing Lead

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Primary Duties

The External Manufacturing Lead will oversee and manage the external manufacturing vendors and sites (CMO/CDMOs) providing drug substance, drug product, final formulation, aseptic filling and packaging/labeling services for drug product intended for commercial and/or clinical distribution. This person will collaborate with the Supply Chain department and CMC Program Leads to ensure timely and accurate delivery of clinical and commercial drug substances and drug products manufactured at CMOs.

The incumbent will lead cross-functional programs across external manufacturing sites through site selection, scope of work and contract definition, technology transfer procedures, standardized comparability and process validation requirements, and trending of key in-process operational data. The incumbent will be responsible for working with existing teams and/or assembling new teams as needed for each project.

This position will participate in external manufacturing site selection, external manufacturing network/capacity evaluations, and will collaborate, as needed, within Spark and the Roche network to advance Spark's long-term strategy.

This position will collaborate closely with Manufacturing Science & Technology and Technical Development organizations to build the technical package(s) associated with Spark's platform processes, including the drug product container closure system and drug product manufacturing process.

This position may also have responsibilities in external manufacturing vendor oversight in production of plasmids, cell banks, and devices.

Responsibilities

• Accountable for CMO management during external manufacturing drug substance and drug product technology transfer projects and commercial external manufacturing. This will include facilitating and leading internal meetings to ensure alignment between internal teams and the external manufacturing site teams.
• Serve as the primary point-of-contact between the site of manufacturing, the CMO vendor, and Spark.
• Provide technical expertise for external manufacturing issues that arise as part of routine manufacturing, including leading the Spark troubleshooting efforts and technical evaluation of deviations that arise during the manufacture of drug product. Author, review, and approve deviations, change controls, change notifications, CAPAs, and other quality records associated with external manufacturing.

Provide technical and industry expertise in, and not limited to:

• Container closure systems, testing, and validation
• Equipment qualification, media fills/process simulations
• Filter validation, CCIT, shipping validation studies

• Ensure data packages associated with products/processes and studies above are well-defined and referenced appropriately to support regulatory filings and other product-related deliverables.
• Assist with the preparation of regulatory documents, such as INDs, BLAs, CBE-30s, briefing documents, etc., as associated with external manufacturing and related activities. Provide technical support for regulatory inspections both internally and at external manufacturing sites.
• Provide technical support (person-in-plant) during external manufacturing activities. The primary focus of PIP support will be on commercial products, though there will be some support required for late-stage products.
• Collect and assist with the analysis of drug product manufacturing process data for the identification, classification, justification and maintenance of various operational parameters. This includes data required for Continued Process Verification programs and Annual Product Review reports.

Education and Experience Requirements

• BS degree in an engineering or science discipline is required. An advanced degree is preferred.
• 10 years of experience within the pharmaceutical/biotechnology industry is required.
• Experience with vendor/CMO management and oversight is required.
• Process and equipment experience and/or knowledge in the areas of aseptic fill, finish and packaging operations is required. Experience with drug substance processes is a plus.
• Experience in supply chain logistics and security is a plus.
• Direct experience with regulatory inspections and regulatory submissions is required.
• Strong knowledge of GXP compliance as well as USP, EP, ICH and FDA guidelines.

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 $140,000 to $210,000.

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.