CMC Clinical Supply Manager
- Employer
- 4D Molecular Therapeutics
- Location
- Emeryville, CA
- Start date
- Sep 13, 2021
View more
- Discipline
- Clinical, Clinical Research, Science/R&D, CMC
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
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
Company
4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.
At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.
While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.
At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.
4D Purpose Statement: Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients
GUIDING PRINCIPLES
- Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
- Break Boundaries - Question the status quo and innovate beyond conventional approaches
- Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other.
- Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans
We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek 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 generous benefits and provides challenging opportunities for career development.
- Website
- http://www.4dmoleculartherapeutics.com/
- Phone
- 510-505-2680
- Location
-
5858 Horton St. Suite 455
Emeryville
California
94608
United States
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