Senior Clinical Supply Operations Manager

ImmunityBio, Inc.•El Segundo, CA

1d•$160,000 - $176,000•Onsite

About The Position

The Senior Clinical Supply Operations Manager is responsible for overseeing & supporting all aspects of clinical supply planning and logistics in support of ImmunityBio’s clinical programs. This position works collaboratively with Clinical Operations, Quality, CMC Program Management and Regulatory Affairs to gather key study information and utilize available systems to create clinical supply plans and coordinate with internal and external partners to supply the necessary clinical material. The role will work closely with the Clinical Packaging/Labeling supplier to initiate labeling, packaging and distribution orders to ensure the timely supply of clinical trial material to enrolled sites.

Requirements

Bachelor’s degree in Business, Supply Chain Management, Operations Management, Engineering or relevant discipline required
7+ years of business experience with a demonstrated knowledge of Clinical Supply Chain Management concepts and Best Demonstrated Practices required, experience with Global Clinical supply management preferred
7+ years in the pharmaceutical, biopharmaceutical, or biotechnology field with specific experience in Demand Planning, Supply Planning, and Inventory Management required
3+ years of knowledge of computer based Interactive Response System to manage inventory strongly preferred
Must have the ability to work independently and also be an influential team member in a fast-paced, team-oriented, dynamic environment
Strong problem-solving skills including analytical and critical thinking abilities as well as business and financial analysis
Working knowledge of FDA and EMA regulations, as well as cGMP and ICH guidelines applicable to the development and production of investigational and commercial drug products
Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
Proficient in Microsoft Suite (Excel, PowerPoint, Project, Visio, Word)

Responsibilities

Participate in cross-functional Clinical Study Teams and document study assumptions e.g. drug product, number of subjects, enrollment, treatment schedule, etc..
Develop, & Implement clinical supply and inventory plans and timelines, including clinical drug supply labeling, packaging, and distribution to the sites
Manage the Clinical Labeling/Packaging CMO, including initiating the Order Management process and the day-to-day fulfillment of drug shipment requests to depots and sites
Identify and communicate clinical drug supply risks to internal and external stakeholders as appropriate
Manage review and approval of clinical supply documentation (i.e. clinical labels, master batch records, label proofs, purchase orders/quotes) in conjunction with IB stakeholders including Regulatory, Clinical Operations and Quality
Broad understanding of clinical product stability data in support of approved shelf-life and temperature transport and storage conditions
Manage the Clinical Inventory reporting and review process, including broad understanding of interactive response systems to manage inventory including the destruction of obsolete and expired clinical drug product
Develop and Implement new strategies that have organizational impact that enhance overall efficiency of the department
Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Benefits

Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day