Clinical Pharmacy Unit Manager

Alpharma – Making Medicine Accessible

 

Alpharma, Inc. is a growing specialty pharmaceutical company with global leadership positions in products for humans and animals. Alpharma has a growing branded franchise in the chronic pain market with its morphine-based extended release KADIAN® product. In addition, Alpharma is among the worlds’ leading producers of several specialty pharmaceutical-grade bulk antibiotics and is internationally recognized as a leading provider of pharmaceutical products for poultry and livestock.

 

Our Pharmaceuticals Division is searching for a Clinical Pharmacy Unit Manager in Piscataway, NJ who reports to Formulation Development Manager.

 

Basic Function:

Manages and coordinates activities relating to the clinical trial supply-chain (including GMP material storage, inventory and distribution processes, label generation, packaging and labeling operations, and the use of GMP packaging areas) to support technical and clinical development programs at Alpharma, assuring that all activities are completed at high level of quality in conformance with Federal regulations.

 

Responsibilities:

·  CLINICAL TRIAL SUPPLIES (CTS) INVENTORY AND SUPPLY CHAIN MANAGEMENT

·  Manage the clinical GMP inventory system and retain sample inventory system.

·  Manage the CTS supply-chain in close coordination with Formulation Development (FD) and Clinical Development (CD) including the development and implementation of distribution plans.

·  Manage sampling and sample distribution of supplies from clinical GMP inventory. Coordinate with clinical sites for return of CTS.  Manage reconciliation and disposal of returned goods and components.

·  CLINICAL PACKAGING DESIGN

·  Work with CD to determine the optimal packaging configuration for CTS.

·  Determine and develop optimal shipping configuration to maintain product label storage conditions during shipment.  May work with CMOs to develop packaging configurations.

·  CLINICAL LABEL DESIGN

·  Manage clinical label design and approval in close collaboration with CD, Regulatory Affairs (RA) and Compliance and Quality Assurance (C&QA).

·  Procure or produce labels for clinical product shipments and ensures C&QA release of labels where appropriate.

·  PACKAGING AND LABELING MANAGEMENT

·  Manage external contractors for the packaging, labeling and distribution of CTS for projects in all phases of clinical development.

·  Identify and participate in the selection process of CMOs and develop strong working relationships with those CMOs for CTS packaging, labeling and distribution.

·  Manage CMOs for the packaging, labeling, distribution and returning of CTS.

·  PACKAGING AND LABELING OPERATION

·  Maintain and schedule the usage of the clinical GMP packaging and labeling rooms.  Coordinate with FD, CD, facilities and C&QA to prioritize preventive maintenance, calibration and project activities.

·  Manage internal GMP packaging and labeling procedures at the Piscataway facility.

·  Purchase and maintain inventory of raw materials, components, supplies, and equipment to support ongoing activities in the clinical GMP packaging and labeling areas.

·  Contribute to the creation of quality system documents including development reports, SOP’s, and batch records, validation protocols and other GMP documents.

·  OTHERS

·  May supervise other Clinical Pharmacy staff.

 

Requirements: 

·  5 to 10 years of experience in pharmaceutical development or pharmaceutical supply-chain management.

·  In depth knowledge and training in cGMPs

·  Demonstrated knowledge in Clinical Trial Supply packaging, labeling and distribution.

·  Excellent oral and written communication skills in combination with strong interpersonal skills.

·  Ability to work with other functional groups internally and at contractors.

·  Experience managing third party contract organizations.

 

Alpharma offers a competitive salary and a comprehensive benefits package to all eligible employees, which includes a 401K match and tuition reimbursement. 

 

For immediate consideration, please apply online or e-mail your resume with salary requirements to brandresumes@alpharma.com   Only candidates who include salary requirements will be considered.  Please reference NC-CPUM in the subject line.

 

EOE