Senior Manager, Supply Chain Operations

Location
San Francisco, CA, United States
Posted
Jan 12, 2021
Ref
976
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SENIOR MANAGER, SUPPLY CHAIN OPERATIONS

Position Summary:

The primary responsibility of this position is to manage packaging & package design, labeling and label development for clinical products to ensure timely and continuous drug supply to global clinical studies. This role will be the packaging Subject Matter Expert in managing activities for clinical trial material for multinational clinical studies at various stages of development. Working closely with other members of the Clinical Supply Chain team, Clinical Operations, Regulatory Affairs, Technical Operations and GBT's Contract Manufacturing Organizations network, this role will support strategies to ensure clinical and development program goals are met.

The Sr Manager, Clinical Supply Operations role may have additional responsibilities assigned beyond the scope of managing packaging operations. These responsibilities may include, but are not limited to:

  • Study Manager responsibilities for clinical studies. These responsibilities may include translation of study synopses/protocols into actionable drug forecasts, working with Clinical Operations for study site oversight, working with IxRS/IRT's, and drug supply planning to the drug product level.
  • Supply Chain representative on CMC teams to discuss and manage supply related matters for drug substance and drug product manufacturing
  • Responsibilities related to supporting logistics and distribution of drug to support clinical studies and study sites may be required


Essential Duties and Responsibilities:

  • Effectively manage vendors and provide vendor oversight to ensure timelines are met and aligned with internal study execution timelines. Manage external vendor relationships to ensure they are productive and collaborative
  • Coordinate with packaging vendors to ensure accurate and timely set-up of new products in their systems and readiness to begin packaging operations
  • Oversee clinical packaging activities, review and approve batch record documentation, coordinate release of drug for clinical use
  • Manage and monitor production/packaging schedules at packaging vendors
  • In collaboration with Regulatory Affairs, and other cross-functional teams as required, develop and manage label text following country specific regulatory guidance, coordinate translations and proofing processes
  • Coordinate with clinical packaging facilities to ensure proper label inventory levels are maintained
  • Initiate any related GMP documentation including Change Controls, deviations, CAPA's
  • Financial acumen: negotiate vendor contracts as required, manage budgets as applicable
  • Develop and establish Standard Operating Procedures (SOP's) as required, propose opportunities for improvement and identify areas of risk through cross-functional collaboration with various functional departments
  • Effective cross-functional collaborator and communicator. Interface with representatives of the CMC team, Regulatory Affairs, Quality Assurance, Clinical Operations groups, and others as required to meet project deliverables
  • Other activities as required may include assisting with global shipment and logistics coordination of drug product and investigation product (IP), Study Manager responsibilities for early stage clinical studies, and participation in CMC activities for early stage programs


Qualifications:

  • BS/BA or MBA degree
  • Typically requires 7+ years of experience in clinical or commercial bio-pharma supply chain management
  • Working knowledge of cGXP's, familiar with US, EU regulations applicable to investigational drugs and drug development process
  • Good organizational and communication skills, effective project and time management skills, and able to meet tight timelines. Excellent interpersonal skills
  • Customer Service oriented, collaborative and self-starter
  • Proficient in Microsoft Office Suite, MS Project. Excel modeling capabilities a plus
  • Vendor management experience, specifically with Clinical Packaging and Distribution vendors
  • Clinical and/or commercial bio-pharma supply chain planning or materials management, inventory management, and business process facilitation
  • Experience with supplying global randomized, blinded studies
  • Some travel may be required (< 10%)


Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.