- Provide strategic and operational leadership with respect to Imbria's global supply chain function including demand/supply/capacity planning, sourcing, clinical labeling, packaging, inventory management, , import/export and distribution.
- Assume responsibility for tracking changes in forecast requirements for pre-clinical and clinical studies.
- Track API and DP inventory across all internal and external manufacturing sites.
- Support clinical packaging sites, as needed, and ensure clinical drug inventory levels are maintained in accordance with study plans.
- Manage the manufacturing plans across all CDMOs and ensure communication of forecasts to manufacturing partners.
- Support import/export of GMP and non-GMP materials.
- Ensure full compliance with import permit, customs duties and VAT requirements for clinical material shipments and develop appropriate Supply Chain SOPs to support.
- Establish policies and procedures to support product launch and scalable commercialization efforts.
- Identify and communicate any risks to clinical program timelines due to manufacturing delays.
- Develop appropriate supply risk mitigation strategy via inventory planning.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Company policies and procedures.
- Minimum Bachelor's degree in supply chain, pharmaceutical sciences, engineering, or related field required.
- Minimum of 8 years of pharmaceutical industry experience in supply planning.
- Experience in Clinical and Commercial Supply required, along with strong understanding of cGMP and cGCP regulations.
- Experience working with third-party CDMOs manufacturing cGMP clinical supplies.
- Experience with MS Project and Excel at a minimum.
- Knowledge of import/export regulations, including pro-forma invoice generation and global trade compliance.
- Proven track record of effective collaboration with external logistics providers.
- Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
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Director Supply Chain - Boston, United States - Imbria Pharmaceuticals
Description
Company Overview
Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in early 2025. For additional information, please visit
Position Overview
We are seeking a Director Supply Chain who is experienced, highly energetic, and committed to developing and executing the company's supply strategy across all clinical and pre-clinical programs. This individual will be responsible for designing, building and shaping the supply chain capability for future growth into multiple clinical studies and commercial launch. The individual will be responsible supply planning, vendor forecast management, logistics and cross-functional communication.
In addition, the Director Supply Chain will implement cGMP planning tools across all stages of manufacturing to ensure that the CMC team is aligned with the manufacturing strategy at each CDMO. A strong knowledge of cGMP supply and experience working with manufacturing and distribution operations as well as knowledge of cGMP and FDA/EMA guidelines is required. Note: This position requires the incumbent to reside in the Boston area.
Responsibilities
Qualifications
This position requires the incumbent to reside in the Boston area. We offer a competitive total compensation package and invite you to consider a career with Imbria
