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
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.
Education and Experience Requirements
- 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.
Minimum BS in a relevant scientific discipline
Key Skills, Abilities, and Competencies.
- 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
Complexity and Problem Solving
- 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
- Must be able to manage and prioritize outsourced testing for multiple projects/studies.
Internal and External Contacts
- 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: 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.
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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.