Share this Job

CMC Program Management Lead

Date: Feb 15, 2021

Location: Philadelphia, PA, US

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 challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

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

 

 

The CMC Program Management Lead is responsible for leading cross-functional teams within the Technical Organization on portfolio programs from inception through completion, coordinating activities to develop the physical product, manufacturing process, supply chain and regulatory filings for successful preclinical, clinical, launch and ongoing commercial supply. 

In this role, the incumbent will build, grow, and mature the CMC function.  This individual must possess strong communication skills and must be savvy working with research, technology, process development, analytical development, manufacturing, clinical and regulatory 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 anticipated, identified and tracked. Plans to resolve these issues must be developed and solutions executed.
 

Reporting to the Head of Technical Strategy & Operations, this position is accountable for the successful and timely completion of projects including:

  • Definition and management of product CMC and lifecycle strategy
  • Establish integrated program plan and delivery of CMC activities following candidate proof of concept up through new product launch and post launch improvements.
  • Support successful pre-clinical and clinical study execution
  • Support regulatory filings, strategy development and agency interactions
  • Process and analytical development, Scale-up, Technical Transfer and supply as required
  • Process Improvements

 

Responsibilities

  • Accountable for defining and successfully delivering aspects of the CMC strategy for a specific product along with obtaining and managing required resources and budget.

 

  • Leads matrix teams and coordinates activities across the Technical Organization and with Project Management functions in Research, Development, Quality and Regulatory (including external partners) to develop the physical product, the manufacturing process, establish an integrated program plan and deliver regulatory files, pre-clinical/clinical studies, successful launch and ongoing commercial supply.

 

  • Leads the development of an integrated CMC strategy and plan. Provides input to the overall lifecycle strategy of the product and represents the Technical Organization on Candidate Development and Asset Teams.

 

  • 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 Research, Development, Quality and Regulatory and ensures the Technical 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 Program Management function.   

 

  • Directs project communications and ensures that all stakeholders 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

 

Requirements

  • 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 in a CMC related role.
  • Must have a relevant CMC knowledge on developing, manufacturing and industrializing pharmaceuticals along with a thorough working knowledge of the , Vaccines, Biotech or Gene therapy industry, relevant regulations and requirements.
  • Experience in Vaccine, Biotech, Gene Therapy process development &/or technical transfer activities to manufacturing sites preferred
  • 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 processes, analytical development experience is a plus.


Nearest Major Market: Philadelphia