Senior Specialist/Manager, Supply Chain

Location
San Carlos, California
Posted
Jul 10, 2018
Required Education
Bachelors Degree
Position Type
Full time

Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.

The company is seeking to recruit a Senior Specialist /Manager, Supply Chain Management.  The ideal candidate will possess the following:

Position Summary

The supply chain Senior Specialist/Manager will be responsible for end-to-end clinical supply chain management activities related to managing supply of Investigational Product (IP) including packaging, labeling, distribution and demand forecasting for multiple clinical studies through all stages of clinical development. The role will partner closely with the Allakos Clinical and CMC/Manufacturing teams and partner stakeholders to ensure timely and uninterrupted supply of IP required for clinical studies. The individual must have the ability to work independently and be an effective team member in a fast-past environment.

Primary Responsibilities

  • Act as a key interface between the CMC and clinical operation teams
  • Manage all aspects of clinical packaging and labeling activities including label design, translation, production, distribution and inventory management
  • Provide total demand and translate the total demand into a demand forecast over time based on a clinical protocol or study overview
  • Prepare a supply plan to support the demand forecast, including determination of supply overage amounts, monitor inventory and provide regular inventory update to project teams
  • Set up Interactive Response Technology (IRT) Systems with the clinical team, including UAT testing
  • Monitor drug expiry/retest dating; initiate inventory release and re-supply with the IRT system, serving as the unblinded inventory manager
  • Manage domestic and international distribution and logistics for clinical programs, including importing and exporting clinical supplies and developing distribution instructions with clinical supply vendors
  • Coordinate logistics of material transfer for drug substance, drug product and components to/from international CMO’s, managing exportation, applicable USDA/FDA licenses and permits, VAT recovery and customs brokers
  • Investigate and work collaboratively with QA to resolve shipping temperature excursions, investigations, and deviations in a timely manner
  • Support budget activities, including managing proposals, contracts, PO generation and invoicing approvals for clinical packaging/distribution/storage
  • Review departmental SOPs and ensure updates and compliance with industry standards
  • Develop strong internal collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality, Manufacturing, and Project Management functions, to ensure high customer satisfaction

Qualifications

  • At least ten (10) years of experience in Clinical Supply Chain Management and/or Manufacturing functions in the pharmaceutical and/or biotechnology industries. Title based on experience
  • Bachelor’s or Master’s Degree in a scientific discipline
  • Detailed understanding of the pharmaceutical business, especially clinical development and manufacturing
  • Proven experience with forecasting, demand/supply planning, inventory management, clinical, packaging, labeling and distribution including cold chain, import/export and reverse logistics
  • Experience with clinical blinding practices
  • Experience in assisting set-up of IRT Systems for global clinical studies
  • Demonstrated skills in project management and CMO/CRO vendor management
  • Working knowledge of drug development process (Phase I-IV)
  • Working knowledge of current GMP/GCP/GDP guidance and regulations
  • Familiar with US and EU import/export regulations
  • Excellent attention to detail, strong data analysis, problems solving and decision-making ability all while working in a fast-paced and dynamic environment
  • Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders
  • Ability to handle multiple projects simultaneously
  • APICS certification or supply chain education preferred

Other Information:

  • Position may require occasional evening and/or weekend commitment
  • Position may require occasional travel (up to 20%), domestic and international

The salary is competitive and commensurate with experience and qualifications.

Interested applicants please send resume to CMCcareers@allakos.com

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.