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Process Development Downstream & CMC Leader

Date: Dec 2, 2018

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.

Summary

The Process Development Downstream & CMC Leader will report directly to the Head of Process Development /Technology Development and is a core member of the leadership team.  Responsible for developing and leading the downstream process, formulation development and PD CMC Regulatory requirements for the manufacture of Spark’s platform products.  

S/he will work closely with other internal cross functional leaders in regulatory, technical operations and quality assurance in support of CMC regulatory strategies for the development of manufacture process and quality of the drug products. 

Partners with the clinical team to lead the identification and development apparatus for product delivery, including determination of the product delivery efficiency and qualify the apparatus for clinical use.  Works with other senior PD leaders to streamline PD/Tech development operations including upstream, analytical methodology development, as well as technical transfer. 

Responsibilities

25%       Downstream

  • Drives the direction and leadership of the PD downstream team.   Leads set up of drug product quality profiles of rAAV-based products and to develop cost effective, operations, robust and fully scalable rAAV downstream purification processes, including drug product final vialing strategies
  • Oversees all aspects of the downstream development of platform based new technologies, AAV-based, non-AAV based (when identified) to ensure Spark’s leading competitive status
  • Leads data analysis and troubleshooting.  Writes, reviews and finalizes downstream technical reports. 
  • Oversees and manages the day-to-day operations of vivarium

20%       Formulation

  • Drives the direction and leadership of the formulation development team.   Leads the development of formulations for AAV and non-AAV based products
  • Works closely with R&D and clinical development to lead the identification and testing of product delivery apparatus, ensures the safety and efficiency of product delivery 
  • Accountable for final product delivery protocols

10%       Technical Transfer

  • Partners with technical operations team members and external partners to develop efficient technical transfer processes/policies to ensure high quality technical transfer of projects
  • Leads the troubleshooting of process related cGMP manufacture/operations issues by providing SME advice and guidance
  • Advises the Head of Process Development/Technology Development and senior management on goals and project direction

Responsibilities (cont'd)

15%       CMC

  • Serves as the PD cross functional representative in the coordination, preparation and management of CMC regulatory requirements.  Partners with Technical operations, QA and Regulatory teams to develop PD CMC function and capabilities, implement QbD principles on downstream process and formulation development
  • Ensures safety and quality of drug product manufactured
  • Designs strategies to characterize and validate newly developed downstream processes, leads the execution of process validation projects

20%       PD Operations

  • Supports PD/Tech Dev senior management team in operational planning, including prioritizing projects to ensure alignment with Spark corporate goals and objectives
  • Directs appropriate resourcing budget development and budget management by strategic assessment of workload, required planning for staffing, coordination of consultant activities as needed and ongoing review of forecasted expenditures.  Ensures appropriate allocation and utilization of resources
  • Participates in the design of new facilities, including cGMP manufacturing facilities and PD labs.  Identifies and brings in appropriate instruments for PD operation, ensures professional, safe and efficient lab working environments.   
  • Provides advice to PD head about PD operations.

10%       Expectations of People Managers

  • Foster Spark’s Culture:  Role model the Spark Values; Create an environment where all team members thrive by living our truths, always in compliance with applicable laws and regulations.  Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
  • Hire & Integrate.  Know what skills, experiences, and capabilities are needed to achieve current and future business goals.  Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values.  Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives.  Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
  • Manage Performance.  Ensure every team member has clear and measurable goals, knows what is expected of them, what it takes to be successful, and how they are progressing.  Provide every team member with continuous feedback and ongoing performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values.  Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes, adjusting goals as needed.
  • Develop People.  Understand each individual team member’s career goals, strengths and motivators.  Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.

Requirements

  • Ph.D. in bioscience or bioprocess related fields required
  • Generally, has 15 or more years of industry bio-process development working experience
  • Experience leading and managing bio-processing teams/projects a must
  • Deep experience in downstream process development of bio-products, including essential downstream techniques. 
  • Must be experienced with process scale-up and scale down models, technical transfer principles and process validation. 
  • Capable of troubleshooting downstream process development related issues and resolving complex problems
  • Good knowledge of CMC regulation and cGMP operations, experience in designing product quality profiles, process validation strategies and raw material control/selection processes
  • Experience on late stage bio-product development leading to BLA filling
  • In-depth knowledge and working experience on bioproduct formulation development, capable of designing/development formulation for drug product, selection appropriate vials/stoppers for drug product, and design vialing strategies. 
  • Capability in leading of designing/selection and qualification of drug product deliver apparatus

Qualifications

  • Strong leadership and communication skills, with special emphasis on collaboration skills
  • Ability to lead cross functional teams in problem resolution
  • Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions
  • Excellent prioritization and organizational skills
  • Strong written and verbal communication skills in English
  • Ability to motivate, develop, and inspire his/her team members and direct reports
  • Capable to present scientific/technical materials in professional conferences, write regulatory documents, including BLA filing documents, process reports and technical transfer documents.  Experienced in process validation. 
  • Proven ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and prioritize accordingly to meet program timelines.
  • Comfortable in the fast-paced, biotech start-up environment and interact with multi-disciplinary research teams at Spark. 
  • Uses extensive project leadership experience to drive the planning and management of risks, priorities and contingencies
  • Excellent computer skills:  including Word, Excel, and PowerPoint skills


Nearest Major Market: Philadelphia

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