Supply Chain Coordinator - Contract

Location
Emeryville, CA
Posted
Apr 06, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
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 performs routine administrative and physical tasks focused on GMP material receiving, transfer, and maintenance. This position will be responsible for assisting in all aspects of delivering an efficient material flow within a single manufacturing facility growing into two in close proximity. This position will work within a team environment, closely with Manufacturing and Quality, to make problems visible & to take initiative and directions to promote performance excellence and compliance at all times. This role also have some interaction with the Process Development and Analytical groups for material coordination and transfer. Perform all company business in accordance with Government (cGMP, FDA, DEA, OSHA, Safety) and Company Policies, Procedures, Goals and Objectives.
Responsibilities:
  • GMP material receipt and release: 40%
  • Responsible for receipt, inspection, release, and shipment of GMP materials. Works with various groups to resolve discrepancies discovered during the receipt/inspection process. Prioritizes materials based on current schedule/needs.
  • Puts material into proper storage locations after receipt using material handling equipment, including occasional use of pallet jacks.
  • Ensures accurate GMP records are kept by scanning and filing on a daily basis.
  • Inventory Management/ Material Control: 40%
  • Conduct proper inventory control practices, including status labeling, material segregation, and storage with pre-identified temperature and hazmat considerations. Work with Environment, Health and Safety (EH&S) team to ensure proper documentation is in place for GMP material.
  • Monitor inventory levels and usage of material. Perform material issuance to various functional team and replenish general consumables as needed.
  • Facilitate material transfers between storage area in two different buildings in close proximity.
  • Reinforce housekeeping practices (cGMP) on a daily basis. Keep inventory and work area clean, organized, and safe.
  • Coordinate warehouse housekeeping efforts for all internal/external audits.
  • Complete routine cycle count of GMP inventory to to maintain inventory accuracy. Support inventory review and root cause analysis.
  • Equipment maintenances: 10%
  • Receive and storage of GMP equipment appropriately. Organize delivery and receiving schedules.
  • Work with service providers for pick-up, servicing, and return of GMP equipment.
  • Archive Equipment Calibration Certifications by collecting, scanning, and filing on a regular basis.
  • GMP document support: 10%
  • Draft material specifications and conduct periodic review to ensure accuracy of effective documents. Update function specific Standard Operating Procedures as needed.
  • Provide receive and release documentation as needed.
  • Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Qualifications:
  • College degree required.
  • Experience:
  • 2+ years working in a regulated medical device or biotech company with a clear understanding of inventory management.
  • Familiarity with inventory control systems and computer office programs, such as Microsoft Office.
  • Must regularly lift and/or move up to 20 pounds, frequently lift and/or move up to 40 pounds, and occasionally lift and/or move up to 60 pounds.
  • 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 Material Control operations and procedures associated with the stockroom, shipping and receiving
  • Solid written and verbal communication skills.
  • 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.
  • During COVID-19, this person will need to be on site for 3-5 days a week and adhere to 4DMT Covid protocols and policy.

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