Manager, Clinical Supply Chain - Novato, CA | Biospace
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Manager, Clinical Supply Chain

BioMarin Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
9/19/2017
Position Type:
Full time
Job Code:
13465
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Description
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients' lives.

SUMMARY
Work independently with minimal supervision performing end-to-end clinical supply chain management activities.  Lead the creation, management, and communication of supply, demand and operational plans from preliminary study set up through study close out activities.

Partner with other BioMarin team members to ensure clinical trials are appropriately supplied with product; ensure inventory levels are maintained at depots and sites.  Provide study information/ updates and technical supply chain expertise to support various processes such as demand/ supply planning, IXRS development, implementation and management, and inventory management including allocation and distribution.  Analyze clinical supply chain processes and associated processes, and contribute to improvement efforts.

RESPONSIBILITIES

Facilitate the retrieval of Import Permits if required; working with Logistics, Regulatory Affairs, CLO and CRO

Ensure Regulatory “green light” as well as “technical green light” (i.e. QA/ QP release) is in place prior to initial and re-supply shipments to clinical sites
Track shipment (i.e. status) of clinical supplies
Process manual ship requests for non-IXRS studies
Manage Temperature Excursions
Determine status of supplies as a result of excursions during shipments as well as on site excursions
Escalate excursions to QA as needed
Supporting investigations due to temp excursions
Provide training to designees
Clinical study team member
Participate in regular study meetings
Track appropriate approvals (i.e. EC, RA, protocol amendments, expiry dating, country-specific labels) and communicate progress to various team members such as CMO and QA.

IXRS team member
Participate in evaluation of IXRS vendors
Participate in URS review/ approval and UAT

Manage clinical supply inventory/ re-supply strategy in IXRS

Participate in regular IXRS team meetings
Review protocol, provide feedback, share info with Clinical Planning team; ensure Planning team is keptupdated on any study changes that may affect IMP requirements
Provide guidance for returns for destruction (i.e. ensure site can provide Cert of Destruction, or provide return to depot information)

Perform Final IP reconciliation
Contribute to the Pharmacy Manual
Participate in Investigator Meetings

Requirements

EXPERIENCE

Minimum 8 years' experience in the clinical supply chain field required
Minimum 3 years' supervisory experience within clinical supply chain required
Inventory management experience required, 3 years minimum
Working knowledge of current GMP/GCP regulations required

IXRS experience required
Distribution experience, including Cold Chain required
Experience in biopharmaceutical manufacturing preferred.

Demonstrated proficiency with Microsoft Excel and good working knowledge of other MS Office applications.

Demonstrated ability to manage multiple projects and priorities, and have strong data analysis, problem solving, and decision-making ability
Demonstrated ability to workwith all organizational levels and work effectively in a team environment, demonstrate strong verbal and written communication skills
Demonstrated examples of a high level of personal initiative and ability to function autonomously with a strong sense of urgency, self-confidence, and comfort with new and rapidly changing situations and environments
Experience with ERP systems highly desirable; Oracle R12 Business Suite preferred.

EDUCATION

Bachelors in Operations/Supply Chain Management, Engineering, or related Business field
Clinical supplies or Clinical Research training required
Proficient knowledge of Microsoft Excel, PowerPoint and Project software required
Formal forecasting or statistics training preferred

APICS certification (CPIM, CRIM, CSCP) preferred.

Proficient in Operational Excellence,  Lean Process development, Six Sigma tools and techniques desirable

EQUIPMENT
Standard Office Equipment

CONTACTS

Commercial Operations - All levels
Clinical Operations - All levels
Contract Manufacturing - All levels
Quality - All levels
Regulatory - All levels
Warehouse / Purchasing - All levels
Business Partners - All levels
Software Contractors

SUPERVISOR RESPONSIBILITY  3 FTEs are direct reports; title is Clinical Supply Chain Associate or above

#LI-SM1

~BIO