Manage the relationship and day to day manufacturing operations at Amylin's Contract Service Providers (CSP) and Alliance Partners (AP) to ensure on-time delivery of high quality compliant commercial products and services to meet patient demands and inventory strategies.
Acts as primary point of contact or main liaison between Amylin and the CSP or AP manufacturing site.
Oversee manufacturing operations at CSP or AP site as appropriate including person-in-plant, batch monitoring, participating and observing.
Lead a cross functional site management team that meets routinely to (1) plan, manufacture and deliver product(s) (2) communicate and assess impact of issues (3) collaborate and drive issues resolution.
Update management on CSP/AP activities and provide input and recommendations as appropriate.
Coordinate completion of necessary quality and technical activities and the documentation of those activities (change controls, deviations, master batch records, validation reports, etc.)
Provide technical guidance to CSP/AP to trouble shoot issues, on investigations, process validations, process changes and improvements, protocol development and reports.
Ensure management of incoming and outgoing materials for robust supply chains and to meet production schedules.
Coordinate regulatory activities including filings, changes to filings, annual reports, pre-approval inspections and agency audits.
Work closely with CSP/AP to identify process efficiencies and cost reduction opportunities using Six Sigma concepts.
Provide monthly/quarterly reporting of CSP/AP performance metrics, accomplishments and project progress.
Is the CSP/Alliance Advocate at Amylin and the Amylin Advocate at the CSP/Alliance site.
Coordinate and lead Steering Committee meetings, i.e. performance reviews between Amylin and respective CSP or Alliance senior management teams.
Present to Amylin Senior Management CSP/AP performance and overall business assessment.
Lead and influence decision making at site management and management level meetings.
Maintain and ensure compliance to the legal agreements and any other mutually developed documents (Joint Services Documents, Quality Agreements, Supply Agreements, etc.)
Ensure accurate and timely resolution of financial matters.
Manage the product lifecycle and CSP Life Cycle Process including participation in CSP selection, tech transfers and ownership of implementation, manage and exit phases of the relationship.
Assist in negotiating contracts and financial terms.
Lead/Direct/Oversee the transfer of new products/line extensions/new technology from the development stage to commercialization.
Lead or participate in Manufacturing Product Teams as committee chair or project leaders to monitor and drive compliance, quality, capacity and cost reductions projects to completion.
BA/BS degree in Science, Health Care or Engineering related field.
Minimum of 8-10 years in pharmaceutical industry with at least 3- 5 years biotechnology, pharmaceutical or device manufacturing experience required.
Experience in device assembly and/or aseptic parenteral fill/finish required .
Good understanding of Quality systems, GMPs and pharmaceutical regulatory environments required .
Experience managing multiple external relationships required .
Experience leading cross functional teams and driving execution of performance goals required .
Experience working across cultures and with international companies.
Project and/or program management experience with contract manufacturing organizations preferred.
Excellent written and oral communication skills.
Ability to work well with diverse individuals at all levels of a company.
Comfortable presenting to large groups and senior management level individuals.
Proficient use of tactful encouragement and motivation.
Proficient use of Microsoft Office.
Up to 25% travel which may include both domestic and international.
Amylin Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of drug candidates...