Sample Management Team Lead

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Oct 10, 2022

View more

Discipline
Life Sciences, Biotechnology
Organization Type
Pharma

Job Details

Primary Duties

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.

Responsibilities

  • 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.


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

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert