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Head of Manufacturing Science and Technology

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Apr 15, 2023

View more

Discipline
Other, Manufacturing/QA/QC
Job Type
Manager
Organization Type
Pharma

Job Details

The Head of Manufacturing Science and Technology (MS&T) has overall responsibility for building and nurturing an organization to deliver Technical Product Lifecycle Management (Materials, DS & DP) for Spark’s growing pipeline of gene therapies.

Scope of responsibilities include but are not limited to: overseeing deviation support, process control strategy development, validation supporting studies as well as process robustness, process and material characterization support, process data management/intelligence and process validation.

The MS&T Head will be responsible for providing tactical and strategic technical support to the organization that results in safe, high quality, and continuously improving production for GMP programs, processes, equipment, and infrastructure.

This includes the oversight and management ofall technology transfer(new product introductions and effective translation, execution and improvements) into Manufacturing as well as leading Process Engineering and Lab functions to support optimize and improve our expanding manufacturing and supply base at Spark. Provide supplemental support as needed for our external manufacturers and development partners.

Responsibilities

Describe the essential daily job functions and include % of time spent on each.

% of Time

Job Function and Description

50%

  • Build and nurture team to create a high performing group that embodies action orientation, timely and effective communication, and a sense of urgency and collaboration. Inspire team to achieve goals that meet the immediate and longer-term business needs.
  • Be an active and visible change agent, promoting a flexible and open mindset that embraces new opportunities, challenges the status quo, and drives excellence across Spark. Establish strategic goals and objectives that drive responsibilities, organizational performance, and team development.
  • Manage performance. Take responsibility, drive results, and achieve expected outcomes. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback. Hold 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 periodically reviewing objectives to ensure alignment, making adjustments if priorities have shifted.
  • Develop team members. Help employees effectively assimilate to Spark and continually grow through challenging experiences so they can realize their full potential. 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, networks and development opportunities.
  • Promote a productive and cooperative climate. Promote team effectiveness by engaging in a trusting, supportive cross functional partnerships. Resolve conflicts in a constructive manner that allows win/win solution. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
  • Foster Spark’s Culture, Mission, Vision, and Values: Lead by example. Proactively promote positive Safety Culture and cGMP operating principles. Create an environment where team members thrive in our Culture of compliance with applicable laws and regulations.

25%

  • Supporting all aspects of materials, machines, and production processes to ensure optimal efficiency quality process and equipment design, translation execution improve efficiency and reduce costs.
  • process validation including: Process Characterization , Process Validation and Continued Process Verification
Lead and manage the authorship of and/or author/own Technology Transfer Procedures, Manufacturing Batch Records, Process SOPs, Process Validation Protocols, CPV any process related compliance documents

  • As requested by Process Development, evaluate and propose changes to process/technology to improve compliance or efficiency. Implement strategies relating to new process improvements and capital investments.

25%

  • Review deviations pertaining to manufacturing processes and perform product impact assessments for facility, and raw material deviations.
  • Design process characterization protocols as needed, and oversee that Process Monitoring regulatory requirements are being met.
  • Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments in preparation for GMP Manufacturing
  • Approvals of any Manufacturing Change Controls, Validation protocols, and CAPAs

Requirements

  • BS/MS/PhD in Life Science/Engineering or related field required.
  • Minimum 15 years of experience in the Biotechnology or Pharmaceutical industry.
  • >10 years of direct supervisory experience of technical professionals and managerial level staff with demonstrated effectiveness in providing guidance, mentorship and support to staff.
  • Experience in biopharmaceutical based GMP manufacturing science and technology including direct experience in cell culture, recovery and purification
  • Proven track record organizing and operating a manufacturing facility
  • Demonstrated technical project management experience to develop project goals, deliverables and timelines
  • Experience with accelerated CMC development pathways a plus
  • Knowledge of GXP compliance

Competencies

  • The position requires extensive knowledge and experience with cGMP upstream and downstream manufacturing of biopharmaceuticals or biologics and the life cycle management of these processes. Experience with virus or vaccine manufacturing a plus.
  • Demonstrated ability to lead lab operations, process engineers, technical managers and teams to achieve objectives.
  • Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
  • Participates in the budget development process; effectively controls the controllable expenses (OT, Supplies, T&E) within their influence.
  • Experience with SAS JMP a plus.

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

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



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.

Learn more about Spark Therapeutics and view other openings.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Company info
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