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CMC Project Management Lead
Job Opportunity at
Spark Therapeutics, Inc
Posted on May 23
The Technical Operations CMC Project Management Lead is responsible for leading cross-functional teams within Technical Operations on multiple projects from inception through completion, coordinating activities to develop the physical product, manufacturing process, supply chain and regulatory files for successful launch and ongoing commercial supply.
In this role, the incumbent will build, grow, and mature the CMC function within Technical Operations. This individual must possess strong communication skills and must be savvy working with technology, process development, analytical development, manufacturing and business partners across the organization in a collaborative way.
They will also prepare project team and steering committee materials related to their assigned projects and ensure project work complies with established practices, policies, and processes. Project issues and risks must be identified and tracked, and plans to resolve these issues must be developed and solutions executed.
Reporting to the Supply Chain & Network Strategy Lead, this position is accountable for the successful and timely completion of projects within Technical Operations including:
Definition and management of product CMC and lifecycle strategy as required
Delivery of CMC activities up to and including new product launch and post launch improvements.
Process Scale-up, Technology Transfer, Assay Transfer as required
Accountable for defining and successfully delivering aspects of the CMC and supply chain strategy for a specific product along with obtaining and managing required resources and budget.
Leads matrix teams and coordinates activities across Technical Operations and with Project Management functions in Development, Quality and Regulatory (including external partners) to develop the physical product, the manufacturing process, establish the supply chain and deliver the regulatory files, clinical studies, successful launch and ongoing commercial supply.
Supports development of an integrated CMC/supply chain strategy and plan. Provides input to the overall lifecycle strategy of the product
Ensures the principles of operational excellence and risk management are applied
Ensures compliance with Spark’s policies and procedures on development and supply of the physical product, the technical governance, including identification, assessment, escalation and management of technical risk as the product is commercialized and throughout its lifecycle.
Responsible for successful strategic project execution & delivery, team management, governance, prioritization, resource planning, execution tools, training and monthly reporting as they apply to assigned projects and new and improved processes.
Coordinates with teams in Development, Quality and Regulatory and ensures the Technical Operations Team is aware of the project’s needs and plans the capacity and capability to enable delivery in a timely and cost-effective manner, always connecting to the needs of the patient.
Leads the effective transition of the supply chain from development into commercialization and at an appropriate time post -Launch, supports opportunities for further innovation on business processes or technologies.
Builds, grows and matures the CMC Project Management function within Technical Operations.
Directs project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status.
Collaborates with functional leaders to ensure that functional area resources are sufficient to achieve project goals and objectives.
Provides leadership to the team and functional areas to anticipate and identify complex project issues, which pose a challenge to achieving strategic goals. Implements plan to resolve such issues and executes corrective actions.
Selects, evaluates and supports the development of direct reports
Must possess excellent interpersonal, organizational, and written and verbal communication skills.
Must be able to support multiple project teams simultaneously.
Must possess in-depth knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools.
Must be well organized and have a strong attention to detail.
Must be able to work under limited supervision, determine personal work plan, and schedule tasks and activities.
Ability to work both independently and in a team environment.
Ability to communicate effectively across a number of disciplines, experience levels, including to Senior Management.
Typically requires a BA or BS degree in a technical, engineering or life sciences discipline; an advanced degree in business or in a scientific field is desirable
Minimum of 10 years of directly relevant experience including participation in cross-functional project management activities; with 3-5 years of experience as a CMC project manager.
Must have a relevant CMC and supply chain knowledge on developing, manufacturing and industrializing pharmaceuticals along with a thorough working knowledge of the Biotech or Gene therapy industry, relevant regulations and requirements.
Has led technical transfer activities to manufacturing sites (primary and/ or secondary)
Has experience leading matrix teams in a Regulated environment
Has authored CMC sections of NDA and / or MAA for an NBE
Inter-company collaborations to develop medicines as part of a strategic alliance or partnership a plus
Project management certificate a plus.
Must have a thorough understanding of the drug development process
Experience in Biotech or Gene Therapy process development and/or product launch preferred
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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