Contract Laboratory Management Lead

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Oct 3, 2022

View more

Discipline
Life Sciences, Biotechnology
Position Type
Contract
Organization Type
Pharma

Job Details

The Contact Laboratory Management Lead will coordinate with Contract Testing Laboratories (CTLs) to provide methods to support Spark’s pipeline of cutting-edge recombinant viral vector-based therapies. This individual will lead a team of outsource testing coordinators for AAV gene therapies. The incumbent will work in a highly interdisciplinary environment and be expected to communicate effectively and productively with research, development, technical operations, regulatory, quality, and other departments as needed to schedule outsourced testing and discuss results. This lead will manage outsourced testing for methods which are not currently available at Spark or through our partner Contract Development Manufacturing Organizations (CDMOs). The goal for the group is to ensure that outsourced testing is performed to meet project timelines to support Spark’s rAAV platform.

The Contract Laboratory Management Lead will:

  • Oversee a team which coordinates outsourced GMP/PD testing with Contract Testing laboratories (CTLs) and internal project groups.
  • The coordinator manages timelines, contracts, provides status updates and communicates updates to project teams.
  • Research new CTL’s to explore additional technology and method capabilities.
  • The coordinator collaborates with technical teams to provide an assessment of the CTLs capabilities.
  • The coordinator also collaborates with quality teams to ensure the CTL is compliant.
  • Will be involved in GMP testing investigations and deviations.
  • Coordination of method reviews with SMEs

Responsibilities

Will oversee a team to manage and coordinate outsourced testing. This group will coordinate with internal groups to determine outsourced testing requirements. The team will schedule the outsourced testing with the correct Contract Testing Laboratory (CTL). Responsible for ensuring that this testing is scheduled and completed to meet project timelines. The lead will provide additional status reports, testing delays or changes to schedule and report into the pertinent internal project team.

Research new and available contract testing lab capabilities. Assist and coordinate with Spark SMEs the critical assessment of CTL method offerings and technology capabilities.

Work with audit teams to ensure that the CTLs have the correct quality systems in place and are compliant

Manage [Insert Function/Department/Unit] team to achieve business goals and objectives.

  • Foster Spark’s Culture. Role model the Spark Values. Create an environment where 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 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, 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.
Education and Experience Requirements

Minimum BS in a relevant scientific discipline

  • A minimum of 7 years relevant working experience, preferably within an established biotechnology or pharmaceutical company in Analytical Development, QC, Critical Reagents or Sample Management Department
  • Has 3+ years of experience with managing teams
  • Demonstrated expertise in developing methods or performing QC testing
  • Experience with CMC development for gene therapy, biologics, or vaccines is required.
  • Has managed outsourced testing for gene therapy, biologics or vaccines
  • cGMP experience required
Key Skills, Abilities, and Competencies.

  • Background in method development or QC testing
  • Demonstrated ability to manage outsourced testing
  • Fundamental understanding of methods used to support rAAV Gene Therapy products
  • Demonstrated ability to hire & integrate new talent into the organization, manage performance, develop people, and model the company’s values & culture
  • Energetic and eager to manage multiple activities, priorities, and direct reports
  • Strong team player who works closely and effectively with colleagues
  • Excellent written and verbal communication skills
  • Strong organizational skills

Complexity and Problem Solving

  • Must be able to manage and prioritize outsourced testing for multiple projects/studies.
  • Must be able to critically assess unclear, unexpected or conflicting results and guide a path forward.
  • Independent problem-solving skills
  • Must be able to exercise good judgement to determine appropriate action including when discussions with manager or collaborating groups are needed
  • Needs to be comfortable in a fast-paced environment and be able to interact with multi-disciplinary teams at Spark

Internal and External Contacts

Internal: MS&T, QC, PD, AD, AS, QA, Regulatory

Vendor: Contract Testing Laboratories

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.


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.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States

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