Manager, Contract Packaging

(Job Id W339952)
Posted on 5/28/2010
Location:

Greensboro, NC


Job Type:

Full Time


Salary: $95000.00 to $102000.00/year
Degree: Bachelor
Job Description
The primary responsibilities of this position are:

1. Responsible technical support and management of outsourcing projects at Third Party contract packagers. The incumbent will be responsible for supporting projects relating to both finished product and packaging outsourcing. The scope of technical oversight at Third Parties includes finished product processing, packaging, components, controls and evaluation for US Operations. This includes specific responsibility for the oversight and implementation of finished product and packaging technology transfer projects into selected Third Party suppliers.
2. The incumbent is responsible to ensure timely and effective implementation of improved processes for Third Party drug product and packaging projects and processes. Activities also include ensuring that processes and projects are efficiently and effectively implemented, to support goals of quality, cost and customer service, and to ensure compliance to all cGMPs, industry regulations, company guidelines, SOPs and policies pertinent to work performed.
3. Plans and manages, the design, development and testing of container/closure systems. Determines packaging design requirements. Develops comprehensive test plans and performs and/or oversees experiments that benchmark packaging performance and insure all design requirements have been met Responsible for package engineering projects and specifications for all DTM and contract packaging activities. Assures that component specifications are issued in a timely manner to support clinical and commercial packaging activities. Maintains package engineering files and component histories and drafts container closure sections for regulatory filings.
4. Work with Marketing and Sales in the development and launch of new products by coordinating requirements with plant operations and third party suppliers. Manage bulk inventory level, coordinate contract packaging volumes, and demand requirements to manufacturing to meet inventory goals and meet on-time delivery requirements.

5. Manages and develops staff in execution of daily activities required to achieve departmental goals and accomplish departmental responsibility.


ESSENTIAL DUTIES AND RESPONSIBILITIES
Serve as the primary communication point for contract manufacturers
Manage the technical support/needs for finished product and packaging projects at Third Party vendors.
Ensure that an optimal Third Party production and packaging environment is established for outsourced products by:
o Developing finished product and packaging technology transfer programs, in partnership with the vendor, that fully address and ensure process robustness prior to commercial production.
o Optimizing Business Process and Product Improvements at Third Parties to reach new levels of performance, through implementation of Operational Excellence tools and projects.
o Support conformance with regulatory filings initiatives, global agency requirements and safety needs and provide guidance, where possible on global harmonization. This also includes providing technical guidance and knowledge on validation requirements.
o Participate with SH&E as required in pre-production HAZOPs.
Ensure that External Supply Products Metrics designed to achieve product and business objectives in alignment with strategic initiatives are effectively managed relative to product cost and life cycle opportunities through technology improvements which are process robustness, yield etc.
Liaise with Commercial and their customers to capture requirements and specifications to ensure zero defects in customer expectations.
Liaise with Sourcing to negotiate supply agreements and pricing
Liaise with Quality Assurance to qualify suppliers, establish quality agreements, and address non conforming quality
Liaise with Information Technology as required to establish processes and communication between suppliers and Banner.
Develop and maintain packaging specification control systems.

Create packaging specifications to support all new DTM and contract packaging obligations.

Work with component suppliers to reduce cost and improve quality.
Support, develop and implement sustainable packaging initiatives to enhance marketability and demonstrate environmental stewardship.

Documents and approves new/revised package design/device/delivery system/package component specifications.

Issue Change Control, including explanation for revision, affected documents, and disposition of current inventory; and assures it is communicated throughout the supply chain.

Approves molds, dies and other processes used to produce packaging components.

Works closely with Regulatory Affairs and Quality assurance to insure packaging systems comply with all Federal regulations for all clinical, stability, and commercial products.

Recommends solutions to packaging problems through interaction with Marketing, Regulatory Affairs, Operations, Quality Assurance, Purchasing, Engineering, Technical Services, R&D, and vendors.

Identifies opportunities to improve cost effectiveness, line efficiencies and market share of current products.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND EXPERIENCE:
B.S. degree in Engineering, Science or equivalent.
A minimum of 3-5 years relevant packaging Engineering experience in solid dose packaging operations plus 7-10 years contract or in-house management of packaging operations. Project management in packaging or related contract services, preferably within or serving the pharmaceutical or nutritional industry preferred.
Experience in packaging manufacturing and technology is required; with pharmaceutical or nutritional products preferred. Experience in product costing, distribution channels, and FDA regulations are required.
Excellent verbal and written skills and the ability to communicate with internal and external customers is a must. Effective presentation skills are strongly desired.
Demonstrated understanding of production and logistics planning.
Working knowledge of Materials Management concepts and planning systems. Working knowledge of Microsoft Office applications, particularly Word, Excel, PowerPoint, Visio and Project