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Senior Director, Commercial Supply Chain and Manufacturing

Prilenia

Prilenia

Sales & Business Development, Operations
United States
Posted on Friday, January 5, 2024
About Prilenia
Prilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior Director, Commercial Supply Chain and Manufacturing to join its team in the East Coast of the United States or Europe.
We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, is a first-in-class small molecule, holding Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.
Pridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases.
About the role
We seek a forward-thinking supply chain hands-on leader to join our team as Senior Director, Commercial Supply Chain and Manufacturing. This position will establish end-to-end global commercial supply chain strategy and serve as an internal SME for matters related to commercial manufacturing, demand planning and global logistics including packaging, shipping, and serialization validation. The ideal candidate will bring in-depth expertise in clinical and commercial supply chain management, launch readiness, DP manufacturing, packaging and labeling, serialization, supply planning, supplier (CDMO) relationship management, contract negotiation, sales and operations planning (S&OP), inventory management, third-party logistics (3PL), process improvement, and strategic planning. A flexible and innovative problem solver who formulates and executes creative and strategic initiatives to adapt to changing market trends and complex global challenges.
The position will report to the Head of Chemistry, Manufacturing, and Controls (CMC).

Roles and Responsibilities:

  • Establish the end-to-end global commercial supply chain strategy for Prilenia’s lead product in preparation of launching first approved product.
  • Lead packaging, shipping, and serialization validation in preparation for launch.
  • Provide direction and leadership of Prilenia’s CDMOs and other external partners to ensure on-time delivery of products that comply with regulatory, legal and quality standards.
  • Serve as internal SME for matters related to commercial manufacturing, demand planning and global logistics.
  • Management of 3PL operations, including distribution and inventory management.
  • Lead and oversee commercial drug product manufacturing plans.
  • Review manufacturing related documentation: production record, protocols, reports.
  • Ensure on-time production and distribution across Drug Substance, Drug Product, Packaging and Labeling.
  • Develop strategies to ensure that commercial supply chain is robust and create risk mitigation plans to ensure that manufacturing timelines are consistent with the company program Responsible for establishing and monitoring manufacturing and demand planning key performance indicators (KPIs).
  • Develop and implement short- and long-term procurement planning strategies toward ensuring 100% availability of raw materials to manufacturing.
  • Manage clinical supply chain in collaboration with relevant internal teams and external vendors (e.g. CROs).

Qualifications:

  • M.Sc. or BA in science and/or engineering (chemistry, pharmacy, engineering or related sciences).
  • 10+ years of extensive experience and demonstrated leadership in clinical and commercial Supply Chain Management and manufacturing.
  • 5+ years’ management experience in a GMP environment with oral solid small molecule products.
  • Ability to manage 3PL provider/s.
  • Experience in EU supply chain and first launch highly preferred.

Skills:

  • A flexible and innovative problem solver who formulates and executes creative and strategic initiatives to adapt to changing market trends and complex global challenges.
  • Capability to build cross-functional alignment including Quality, Regulatory, Finance, Commercial and Manufacturing partners.
  • Excellent oral, written and interpersonal communications skills to effectively interact, exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership.
  • Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
  • Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
  • Team player with a positive attitude and solid leadership skills who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment.
  • Ability to take initiative, be accountable for individual and team results, and motivate self and others to set and achieve very high-performance standards.
  • Must be able to work under pressure, manage time, set priorities and meet deadlines.
  • Experience working effectively in global virtual setting – a must.

Location/Time Zones:

  • This is a full-time remote position in the East Coast of the United States (preference for Boston area) or Europe (preference for the Netherlands); occasional in-person/face-to-face meetings will occur.
  • Flexible schedule with interactions across Israel, North America and Europe time zones.