CMC Clinical Supply Manager

Location
Emeryville, CA
Posted
Oct 13, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics is located in Emeryville, CA.

GENERAL SUMMARY:
This position will be responsible for managing distribution and logistical activities in support of active clinical studies. This position will work with both internal and external customers, suppliers, and CROs to assist in development and communication of Statement of Works specific for these activities with CRO to ensure that all project objectives are met in a timely, efficient and high-quality manner. 
Responsibilities:
  • Inventory Management for Investigational Drug Products- 40%
  • Communicate, coordinate, and track investigational product and ancillary shipments between 4D, CMOs, and clinical sites. Works with various groups to resolve discrepancies discovered during this process. Prioritizes material flows based on current schedule/needs.
  • Maintain clinical inventory; communicate and coordinate replenishment as needed
  • Track expiry dates of all clinical drug to ensure first lot expiring is pulled for clinical use and that extension memos are provided to Clin Ops/Depot in a timely manner. 
  • Ensure GMP and GCP compliance with proper record keeping
  • CMO Management for Pack and Labeling activities- 40%
  • Coordinate trial supply selection, procurement, storage, labeling and packaging, as well as distribution activities with domestic and international vendors/depots per study plans
  • Review Statement of Works (SOW) with Clinical Operations for pack and labeling activities at clinical depot
  • Setup purchase requisitions/purchase orders for clinical ancillary supplies, storage, clinical kitting / distributions, and oversee operations to completion. Responsible for approving payment to associated invoices and work with Finance and accounting for proper accurals of costs on a regular basis
  • Coordinate pack and labeling schedule with ClinOps team to ensure alignment to overall trial timeline
  • Cross-functional activities: 20%
  • Serve as as the CMC representative in Clinical Trial teams and other project team setting as assigned. Participate in Clinical Study Execution (SET) meetings as Supply Chain Subject Matter Expert as required
  • Provide projected vs. actual clinical product and ancillary consumptions to CMC on a regular basis and communicate changes
  • Other logistic activities, as assigned.
  • Supports supply chain activities related to the CMO, as assigned.

Qualifications
  • College degree required.
  • Experience:
  • 3+ years of related experience in clinical or commercial supply chain management
  • Working knowledge of cGXP's, familiar with US, EU regulations applicable to investigational drugs and drug development process
  • Experienced in pharmaceutical cold chain distribution and temperature control management
  • Knowledge in supply chain, planning or materials management, inventory management, and/or logistics
  • Strong interpersonal and negotiation skills, as well as verbal and written communication skills
  •  Skills:
  • Must be flexible and adaptable in a fast-paced, start-up environment while being organized with the ability to manage multiple projects/tasks simultaneously
  • Knowledge of Inventory Control operations and procedures associated with shipping and receiving
  • Solid written and verbal communication skills; presentation in a group setting will be required
  • Excellent interpersonal and communication skills
  • Positive attitude with a strong desire for continuous learning
  • Ability and willingness to work required over time
  • Physical Requirements of the Role: 
  • Regularly lift and/or move up to 20 pounds lbs and occasionally lift and/or move up to 60 lbs with help. Frequent bending, lifting, and twisting required to satisfactory complete assigned tasks.
  • This position requires physical presence in the office/lab occasionally as needed to ship and receive clinical materials.
  • Must adhere to COVID protocols when in the office

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

About 4DMT:
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused on three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated, and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity, and, where relevant, having resistance to pre-existing antibodies.

Attention: Search Firms / 3rd Party Recruitment Agencies*
The Talent Acquisition / HR team manages the recruiting for all positions at 4D Molecular Therapeutics. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to 4D Molecular Therapeutics will be considered property of 4D Molecular Therapeutics. 4D Molecular Therapeutics will not be responsible for any fees associated should we hire from unsolicited resumes.

Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions. Recruiters interested in working with 4D Molecular Therapeutics can submit their information to recruiting@4dmt.com– should we have a tough-to-fill role, we will contact you directly if you specialize in that area.