Supply Chain Specialist

Supply Chain Specialist

About Audentes Therapeutics

Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases.  We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown.  Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven to improve the lives of patients.

Audentes leverages strong, global relationships with the patient, research, and medical communities, and we take pride in carefully selecting our colleagues.  Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us on our journey.

The Role

We are seeking a highly motivated Supply Chain Specialist, reporting to the Senior Manager, Supply Chain who will provide input and oversight to ensure all operations meet or exceed cGMP regulations, ensuring high level of quality of the Drug Substance and Drug Product Processes. The Supply Chain Specialist will be responsible for the creation and maintenance of Audentes' materials numbers (MTL's) including uploading them to the corresponding data base. The Supply Chain Specialist will be also responsible for the creation and maintenance of Audentes' materials specifications, coordinating the development of supporting data withstakeholder departments, and performing the corresponding electronic data base (EDMS) updates . The Supply Chain Specialist will develop and maintain corresponding procedures as the SME on the areas under their control. This position will be located in South San Francisco.

Responsibilities

  • Creates and updates materials specifications with support from related departments (Manufacturing, PD, QA / QC, etc.), updates the corresponding EDMS and manage their approval.
  • Creates, uploads, and perform updates for materials/components as required into theAudentes ERP system.
  • Responsible for owning and/or assessing Supply Chain deviations/investigations/CAPAs/change controls under control of the Supply Chain group (Warehouse/Purchasing) and related to GMP materials quality issues (SCAR (Supplier Corrective Action Request) procedure) with the assistance of Warehouse Manager and Purchasing group when applicable.
  • Develops / updates corresponding area procedures (SOPs) to ensure GMP compliance.
  • Assures compliance with company policies, applicable GMP procedures and regulatory agencies on matters related to Supply Chain, safety, and environmental.
  • Submits accurate and timely administrative reports, attends meetings, works to resolve any Supply Chain related issues within a timely manner.
  • Maintains / files GMP related data in an organized manner for record / audit purposes.
  • Makes informed timely decisions largely in an independent fashion; assumes responsibility and communicate to appropriate stakeholders.
  • Other duties and projects as assigned.

Required Qualifications

  • BA/BS in Business Administration, Materials Management, Supply Chain with 8+ years or a master's degree with 6+ years, experience within a pharmaceutical or biotech manufacturing environment.
  • Expertise in regulatory compliance with respect to investigations and process change control. As well as, investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions. Strong knowledge of cGMPs / FDA and EU regulations.
  • Previous experience creating / updating materials specifications including chemicals, reagents, solvents, disposable single-use materials, components, etc.
  • Strong technical skills interpreting material specifications in a GMP environment.
  • Strong experience leading technically complex projects.
  • Strong computer skills including MS Office (Word, Excel). Advanced skills with ERP systems (Oracle preferred), MRP and Inventory Control Systems.
  • Excellent communications skills both verbal and written.
  • Strong problem-solving, decision-making skills and time management skills.
  • Strong organizational, prioritization skills, able to multitask / work independently with minimal direction or work in a tean environment, develops and maintains effective relationships with colleagues across the organization.
  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

Preferred Qualifications

  • 5+ years working in a Bio-Pharma environment as a Supply Chain Specialist.
  • General understanding of biopharmaceutical development, clinical research, biologics manufacturing, cell therapy manufacturing.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Job Details

Reference # 2019-IB-016
Posted on 05 Sep 2019
Closes on
Location(s) South San Francisco
Department Tech Operations/Manufacturing
Career level Experienced (non-management)
Hours/Status Full-time
More details (document)
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