Clinical Site Onboarding Lead - Apheresis / Drug Product Supply
- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Dec 16 2019
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines a talented workforce and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
The Clinical Site Onboarding Lead - Apheresis / Drug Product Supply- will be a key member of the Cell Gene Therapy Supply Chain and will be for responsible for developing the Apheresis and Infusion Site Onboarding processes and for establishing the GSK CGT Supply Chain within the Apheresis and Infusion departments at the Oncology Clinical sites. Support of wider Supply Chain activities may be assigned dependent on department priorities.
- Implement GSK supply chain activities at Apheresis/clinical sites either in person or by remote training methods as required. Includes training on GSK tracking activities performed at the clinical sites. As such, the role will involve travel throughout North America and Canada.
- Support supply chain manager in identification and implementation of suitable processes to onboard apheresis and infusion sites for supply chain accountabilities for all assets as applicable within CGT platform.
- Support supply chain manager by identifying gaps, suggesting updates and implementing aligned changes to appropriate SOPs, Protocols and training materials. The ultimate aim is to ensure the implementation of vein to vein supply chain activities at Apheresis/clinical sites.
- Develop then monitor adherence of supply chain to parameters through performance management.
- Ensure appropriate actions are taken to resolve any deviation or exceptions to meet customer requirements.
- Work with internal and external business partners to ensure cell collection centers successfully complete all qualification activities and are prepared to perform collections within the required timelines.
- Provide training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits.
- Work independently to ensure that clinical site Apheresis/collection functions are current as to equipment, training and technology according to internal procedures and recommendations.
- Contribute to the development and maintenance of procedures related to standard cell procurement and Apheresis practices.
- Identify potential supply chain challenges and work across the matrix team to minimise the commercial and/ or clinical impact. Close the identified supply chain issue in the shortest possible time.
- Contribute as required to any advocacy work.
- Responsible for development and implementation of appropriate systems, procedures, and training for compliant management of product, identifying and managing risks, initiating and leading change control, deviation investigations, and CAPA
- Establish good working relationship with clinical team and sites
- Work closely with the CGT teams to ensure knowledge gained at sites is effectively communicated.
- Have a sound understanding of logistic activities at sites and at LSPs
The Clinical Site Onboarding Lead would be responsible for at least one of the following key responsibilities and would contribute to other responsibilities: Apheresis/Infusion site Onboarding, Inventory management, Shipments/logistics, Capacity planning, Patient Supply Coordination, Chain of Custody (Track and Trace), Labeling and Operational Finance.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree, Scientific, Engineering or Nursing
- Excellent communication and interpersonal skills with a track record for building relationships both internally and externally.
- An agile thinker, comfortable and adaptable to dynamic and changing working environments.
If you have the following characteristics, it would be a plus:
- Experience in Cell and Gene Therapy Clinical Trials or Commercial Operations
- Experience working with CRO's and CMO's
- Good understanding of GxP
- 3+ years Laboratory experience and an understanding of biological science
- Good understanding of FACT / JACIE / AABB
- Project management experience / qualification would be an advantage.
- Experience with labelling, packaging and documenting apheresis shipments / receipt of cryo preserved drug product shipments not essential but favorable.
- A focus on compliance to GSK procedures and policies is essential.
- Patient focused with integrity as a key value.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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