About this position:
We are seeking a highly motivated individual for the role of Supply Manager to work in this exciting area of phage therapy. This individual will work closely with the external Vendors (for labeling, packaging, and distribution), Research, cGMP Manufacturing, Quality, and Clinical Operations teams to ensure the clinical trial material (CTM) supply and the operations consumables supply/inventory strategy is clear and the related plans are understood and aligned across functions.
Job description and technical requirements:
- Manage CTM supply and operations consumables inventory, planning, and forecasting.
- Manage protocol-level drug product labeling and packaging activities for clinical trial material. In collaboration with other drug development functions, coordinate appropriate clinical trial materials quantities for stability testing requirements.
- Define, implement, and optimize the packaging schedules that integrate into the clinical trial plans, while keeping within the corporate budget.
- Participate in identifying CRO/CMOs and managing the related contracts and change orders.
- Responsible for providing clinical packaging forecasts to CMOs.
- Lead the effort of process definition, improvement and troubleshooting by appropriate use of resources and by influencing other departments.
- Establish and foster relationships with internal research, clinical operations, cGMP manufacturing, and quality teams.
- Work effectively in a cross functional matrix environment, with internal and external customers and attend relevant team meetings.
- Communicate production and release for distribution schedules to teams.
- Reconcile drug at CMO and keep RTSM and CMO systems reconciled.
- Advise team decisions related to Label/Packaging Regulatory requirements.
- Support quality audits of CRO/CMOs.
- Support operations consumables supply planning and inventory management.
- Develop, implement, and update all relevant SOPs, Batch Records and other documentation needed for cGMP compliance.
- Customarily and regularly exercise discretion and independent judgment in the performance of the duties described above.
- Other duties as assigned.
Qualifications and Experience:
- 5+ years of directly related experience in Biotechnology/Pharmaceuticals.
- 3+ years as the Sponsor primary drug supply manager, working with study blinded/unblinded team members and vendors.
- Expertise in management of labeling, packaging, and distribution of a variety of drug product dosage forms.
- Supply chain management experience for drug manufacturing, release, and distribution.
- Knowledge of the drug development process.
- Ability to work in a matrix environment.
- Excellent organizational, written, and verbal communication skills.
- Effective communication and interpersonal abilities to influence the entire organization to run operations in an effective and lean manner.
- Bachelor’s degree in a scientific discipline is preferred.
This is a full– time position for work in a laboratory environment. The position requires wearing personal protective equipment. Occasionally, may require lifting or moving equipment up to 20 pounds and may require standing for extended durations throughout the day. Upon request, reasonable accommodations will be offered to enable individuals with disabilities to perform essential functions. There is little to no travel required of this position, with the exception of required training and possible conference or event attendance.
About Armata Pharmaceuticals, Inc.:
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.
Pay: $115,000.00 – $130,000.00 – per year
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