- Responsible for developing the manufacturing strategies with CMOs. Build future strategies for defining manufacturing technologies for implementation at Contract manufacturing organizations for different dosage forms
- Developing a long-term plan for third party manufacturing sites on a global scale
- Responsible for developing internal and external benchmarks for operational excellence
- Responsible for keeping abreast with latest developments in drug formulation and pharmaceutical manufacturing
- To lead the Manufacturing sections of the Chemistry and Manufacturing Controls (CMC) sections of New Drug Application (NDA) filings for in-licensed deals
- Responsible for initiating and reviewing the commercial supply agreements for commercial products with CMOs
- Responsible for manufacturing Process Engineering and Development through all phases of development through to commercial scale
- Manage the tech transfer activities of developed products to CMOs
- Manage the operation activities for the supply chain of commercial products
- Researching and evaluating CMOs/suppliers based on production and distribution, quality, selection, service, support, availability, reliability, cost and supplier/CMO's reputation and history
- Analyze price proposals, financial reports and other data and information to determine reasonable product costing and product sustainability for Pharmaceutical Market.
- Evaluate and monitor contract performance to ensure compliance with contractual obligations and to determine need for changes.
- Monitor and follow applicable laws and regulations
- Performing additional duties as directed
- Bachelor's degree in science, pharmacy or engineering from accredited college or university required. Master's degree preferred
- At least 7 years of experience in cGMP pharmaceutical R&D and / or Manufacturing Operations.
- O-2 years of experience with working with third party CMOs on validation and project launches.
- Cross- functional collaboration skills with the ability to network with different functional areas and integrate cross- functional deliverables.
- Strong oral interpersonal and written communications skills.
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Senior Manager, Program Management - Cranbury, United States - Prostaff Solutions LLC
Description
Are you looking to be a part of a growing pharmaceutical company? One of our largest clients is currently seeking a Senior Manager, Program Management - Global Procurement to join their Cranbury, New Jersey team. Our client is one of the leading pharmaceutical companies specializing in developing and manufacturing solid dosage products. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.
Direct Hire
Hybrid
The Senior Manager will lead cross- functional project teams, including internal and third party representatives, to drive development, validation and launch activities for the U.S. market portfolio.
Key Duties and Responsibilities:
The successful incumbent will require having technical expertise in development, tech transfer or scaling up of different dosage forms. He/She should be able to provide guidance on running different projects virtually with Contract manufacturing sites. Primary responsibilities include, but not limited to, managing activities leading to the successful execution of the project; establishing project plans with milestones and deliverables in collaboration with stakeholders (CMO, R&D, Regulatory Affairs, Supply Chain, QA, Legal, Finance etc.); and ensuring accountability of team members for these deliverables. The person will communicate across functional and leadership levels to inform project status and risks, as well as elevate issues, present recommendations and implement modifications to project plans.
The candidate must have experience with diverse dosage forms that include but not limited to: injectables, solid oral dosage forms, semi-solids, soft gels capsules, transdermal delivery systems, liquids, and others as assigned.
ORGANIZATION STRUCTURE
This position reports to Associate Vice President of Third-Party Organization. This position has no direct reports.
RESPONSIBILITIES:
Please visit us at to explore all opportunities.
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