Senior Manager, Clinical Supply Chain

BeOne Medicines • Emeryville, CA • 1h ago

General Description:

The Sr Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical studies. Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners. Has working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment. Works with management to develop and implement process improvements to build the organization for the future.

Essential Functions:

Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC).

Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines.

Create supply and inventory plans and develop production schedules for clinical trial materials.

Monitor schedule adherence of production schedules and make course corrections if needed.

Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability.

Manage the relationship and oversee daily activities for FG label & pack CMOs and distribution vendors.

Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure.

Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).

May coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs.

Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system.

Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses.

Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans

Lead cross functional projects and process improvements related to drug supply.

Creates and/or revise process documents such as Standard Operating Procedures.

Additional responsibilities as required.

Ensure staff who are in supportive roles for supply planning and business process development are meeting deliverables for successful study management.

Education/Experience Required:

Bachelor's or Master's degree in Business Administration, Operations Management, or a related field required.

Minimum of 7 years of progressive experience in supply chain, preferably within the biotech, pharmaceutical, or CRO industry.

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

Similar Jobs

Senior Manager, Clinical Supply Chain

BeOne Medicines • San Mateo, CA • 1h ago

Hospital & Medical

General Description: The Sr Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical studies. Actively develops a...

1h ago

Go to Apply

Cell Therapy Manufacturing Specialist

Kelly Services • South San Francisco, CA • 15h ago

Hospital & Medical

Cell Therapy Manufacturing Specialist Kelly® Science & Clinical is seeking a Cell Therapy Manufacturing Specialist for a full-time, 6 month contract position at a cutting-edge client in South San Francisco, CA . If y...

15h ago

Go to Apply

Cell Therapy Manufacturing Associate

Kelly Services • San Francisco, CA • 15h ago

Hospital & Medical

Cell Therapy Manufacturing Associate Multiple Positions Location: South San Francisco, CA 94080 Company: Cell Therapy Manufacturing Target Salary : $35-$40; BOE Available Shifts Day Shift 7:00 AM - 7:30 PM | Sunday - Tue...

15h ago

Go to Apply

Cell Therapy Manufacturing Associate (Day &Night)

Kelly Services • South San Francisco, CA • 15h ago

Hospital & Medical

Kelly Science & Clinical is seeking a Cell Therapy Manufacturing Associate for a 6 month project with an exciting company located in South San Francisco, CA. Position Summary: Join a dynamic Process Sciences team as...

15h ago

Go to Apply

Strategy& Consulting Manager - Technology Sector

PwC • San Francisco, CA • 1d ago

Hospital & Medical

Specialty/Competency: Corporate and Business Strategy Industry/Sector: TMT X-Sector Time Type: Full time Travel Requirements: Up to 60% The Opportunity As a Strategy& Consulting Manager - Technology Sector, you will...

1d ago

Go to Apply

Bioprocessing Manufacturing Technician

Kelly Services • South San Francisco, CA • 1d ago

Hospital & Medical

Manufacturing Associate, Cell & Gene Therapy Kelly® Science & Clinical is seeking a Manufacturing Associate, Cell & Gene Therapy for a 6-month contract position in the San Francisco Bay Area. If you're passio...

1d ago

Go to Apply

Physical Therapist (PT) for Home Health

FeldCare Connects • San Mateo, CA • 1d ago

Hospital & Medical

This position is for an Independent Contractor to serve the San Mateo area specifically. FeldCare Connects is currently seeking a self-motivated Physical Therapist to deliver premier excellence of care and is enthusiasti...

1d ago

Go to Apply

Account Manager, Healthcare & Transit Partnerships

Lyft • San Francisco, CA • 2d ago

Hospital & Medical

At Lyft, our purpose is to serve and connect. We aim to achieve this by cultivating a work environment where all team members belong and have the opportunity to thrive. Lyft's Healthcare & Community Access team is ch...

2d ago

Go to Apply

Advanced Medical Support Assistant

Veterans Affairs, Veterans Health Administration • Oakland, CA • 2d ago

Hospital & Medical

Summary The Advanced Medical Support Assistant (AMSA) is responsible for a range of clerical and administrative duties that demonstrate the advanced level of the Medical Support Assistant (MSA). The San Francisco VA Heal...

2d ago

Go to Apply

Physician - Infectious Diseases

Veterans Affairs, Veterans Health Administration • Martinez, CA • 2d ago

Hospital & Medical

Summary This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific eligibility requirements per VHA policy and submit your EDRP applica...

2d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)