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 22, 2022
View more
- Discipline
- Life Sciences, Biotechnology
- Position Type
- Contract
- Organization Type
- All Industry, Pharma
Job Details
- 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
- 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.
- 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
- 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.
- 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
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.
- Website
- http://sparktx.com/
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