Expect Sangamo to Add International Clinical Trial Sites

Sangamo Therapeutics, Inc.

JOB DESCRIPTION

 

Title:  Operations Specialist III

Manager:  Associate Director, TechOps Project Management

Department:  TechOps Project Management

 

JOB SUMMARY:   

The Operations Specialist III will interface with internal resources/stakeholders and external vendors/contractors to develop, implement and manage clinical supply logistics processes and strategies in support of the company’s gene therapy and genome editing products.  Primary focus will be related to planning and logistics for products that are manufactured, stored and distributed by Contract Manufacturing Organizations (CMOs) with clinical studies executed in both the US and Europe.  Role will liaise with internal resources within Clinical Operations, Technical Operations and Finance in addition to CMO representatives and logistics vendors.

 

ESSENTIAL FUNCTIONS: 

 

1. Responsible for GMP inventory management including record keeping for all inventory generation, requests (both GMP use and non-GMP use), movement and disposition as required.
2. Works with vendors to ensure accurate counts (physical inventory vs. virtual inventory records).
3. Manages proposals, contracts, PO generation and invoicing approvals for storage and clinical kitting / distribution vendors.
4. Understands clinical trial protocol requirements and translates into logistics strategy that accounts for study design, clinical site requirements and geographic location.
5. Identifies risks and assumptions in plans, anticipates problems and plans for contingencies. Removes obstacles to move work forward and/or to get efforts back on track.
6. Provides input to and reviews vendor generated clinical distribution procedures to ensure compliance with study requirements.
7. Maintains current understanding of US import/export regulations, reviews upcoming or potential regulation changes and proposals, and supports awareness of these changes across applicable functions within Sangamo and applicable third parties.

 

 

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

The ideal candidate for this position will have demonstrated in-depth experience of clinical inventory management and study logistics.

Candidate must possess:

• Minimum of a Bachelor's degree in Business/Operations Management, or Chemistry, Pharmacy or equivalent life science field
• Minimum of 3 years related experience in the biotechnology or pharma industry, ideally for Advanced-therapy Medicinal Products (ATMPs) including cell and gene-based therapies
• Minimum of 5 years’ experience in commercial or clinical supply logistics
• Knowledge/experience with trade and customs regulations and global import export requirements
• Demonstrated skills in project management and working with vendors
• Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders
• Experience with sourcing, contract distribution, supplier management and supply chain management is highly desirable
• Strong background in FDA, ISO, EMA, GMP and ICH requirements ideally for ATMP's a plus
• Advanced knowledge of drug development process, experience with cell-based, gene-based and rAAV-based therapies a plus

 

OTHER REQUIREMENTS:

• Excellent interpersonal skills
• Outstanding organizational skills
• Excellent written and oral communication skills
• Strong focus on customer service
• Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including bonus and stock option plans. Sangamo offers a comprehensive benefits program, including:  medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k) and Employee Stock Purchase Plan. Sangamo is an equal opportunity employer.

Please send your resume/CV and a cover letter that specifically addresses this job posting as email attachments to: jobs@sangamo.com

The above reflects management’s definition of essential functions for this position, but does not restrict the tasks that may be assigned.The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.