Manage the Sample Management team:
Oversee day to day activities of Sample Management Staff
Develop continuous improvement Initiatives within cross-functional groups (i.e. QA, QC, Clinical Operations, SLIMS, laboratory groups, etc)
Write policies and SOPs for Sample Management
Assist when needed in the receipt and management of incoming samples.
Ensure that freezers and CTUs are in the appropriate qualified state and in top operational order.
Lead long term goals of Sample Management (bio-repository, space organization, sample integrity, chain of custody, etc,)
Be point of contact for international shipping (CDC permit, CITES, Fish and Wildlife, etc.)
Be point of contact for offsite storage facility.
Work with Quality Groups to resolve discrepancies, quarantine, release and disposition of product under the custody of sample management.
Training on sample management procedures
Collaborate with Lab Information Management System (LIMS) and Benchling teams to improve the Sample Management portion of LIMS and electronic lab notebook
Work closely with Scientific Facilities to ensure that PMs, and emergency maintenance on controlled temperature units is performed in a timely manner.
Work with senior management to ensure that Staffing and program is at the appropriate level commensurate with ongoing studies to ensure that samples for all studies are organized, properly received, delivered, and maintained in a compliant, efficient and timely manner.
Oversee the development and mentoring of staff and ensure that personal responsibilities and goals align with corporate and scientific goals.
- Responsible for successful strategic project execution & delivery, team management, governance, prioritization, resource planning, execution tools, training and monthly reporting as they apply to assigned projects and new and improved processes in sample management, inventory and general lab operations.
- Responsible for managing the sample management team. Works in partnership with project team members to ensure timely, efficient, and effective moderation of complex meetings, and to ensure adequate progress on team activities between meetings. May chair project team meetings and is responsible for coordinating complex team operations and communications.
- Directs sample management communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status.
- Collaborates with functional leaders to ensure that operations and sample management area resources are sufficient to achieve project goals and objectives. Provides leadership to the team and functional areas to anticipate and identify variably complex issues, which pose a challenge to achieving strategic goals. Implements plan to resolve such issues and executes corrective actions.
- Leads the design and implementation, of a biorepository for the Spark labs
Education and Experience Requirements
- Typically requires a BA or BS degree and minimum of 5 years of relevant experience,
- Experience working in a Regulated environment a plus
- Personnel management experience needed
- Experience working in a Pharmaceutical/Biotech company required
Key Skills, Abilities, and Competencies
- Experience should include participation in cross-functional project management activities.
- Must have a thorough understanding of the drug development process.
- Must have a basic understanding of and application of principles, concepts, practices, and standards of biotech/pharmaceutical operations.
- Must possess excellent interpersonal, organizational, and written and verbal communication skills.
- Must be able to support multiple project teams simultaneously.
- Must possess in-depth knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools.
- Must be well organized and have a strong attention to detail.
- Must be able to work under limited supervision, determine personal work plan, and schedule tasks and activities.
- Ability to work both independently and in a team environment.
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.