Poseida is seeking an outstanding candidate to build and lead our supply chain and clinical product logistics capabilities. This will include sourcing, materials management, inventory control, demand planning, contract negotiations, and management of third party logistics vendors.
These may include but are not limited to:
- Evaluate and plan requirements for materials and production services
- Track inventory of materials and ensure accuracy of inventory records
- Support supply scenario planning and assessment and may present to Senior Management or other stakeholders to support decision-making
- Collaborate with Finance team to provide inventory and material data to support accounting, budgeting and other financial activities
- Maintain and update the transportation network including set up of new shipping lanes and new logistical providers, when required
- Manage coordination and execution of shipments of materials
- Oversight and management of logistics vendors
- Lead key innovation and process improvement initiatives to help build internal capabilities and efficiencies with process and systems
- Develop, manage and document aggregate forecasts of required product materials across all clinical programs
- Develop supply plan strategies and timelines for all clinical studies
- Interpret clinical study protocols to forecast drug product and comparator product needs
- Evaluate and audit technical supply operations to support vendor selection
- Vendor management including negotiations of contracts
- Provide oversight for importation/exportation compliance of labeled supplies to the appropriate drug depot and subsequent shipment to clinical sites as required
- Track work orders and invoices to contracts and approve monthly invoices
- Partner with Regulatory Affairs and Clinical Operations groups to support regulatory filings and ensure timely drug supply for clinical trials
- Support stability packaging forecasts and supply
- Act as the supply chain subject matter expert at project and clinical program meetings
- Create and maintain departmental supply chain-related Standard Operating Procedures (SOPs)
- Onboard and manage relationships with vendors, including the establishment of agreements, quotes, purchase orders and invoicing
- Participate in inspection readiness efforts for both internal and external audits
Requirements, Knowledge, Skills and Abilities
- Minimum of Bachelor’s degree in a scientific discipline with at least 12 years of work experience in the Pharmaceutical/Biotechnology industry and 6 years direct experience in supply chain and logistics (an equivalent combination of education and experience may be considered)
- Cellular therapy and CAR-T experience preferred
- Business acumen and advanced negotiation skills
- Expert knowledge of FDA and ICH GxP regulations and guidelines
- Excellent people leader with strong coaching and mentoring skills
- Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams in a fast growth environment
- Demonstrated problem-solving and critical thinking skills
- Demonstrated ability to work effectively in a dynamic, complex and fast-paced team environment
- Travel may be required up to 10% of the time
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
To apply send your resume and cover letter to firstname.lastname@example.org.