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Posted: Sunday, February 11, 2018 12:07 AM

Job Description
Head of Manufacturing (Chemistry, Manufacturing and Controls (CMC)
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Scientific Search client, a leading late stage Oncology company, has an immediate need for a Head of Manufacturing. This is a full time direct hire position, with a dynamic growing organization. They are a company united by strong values : passion, customer focus, innovation, adaptability and integrity. Their values reflect the way they strive to improve the quality of life for patients, and are at the heart of the companys success and future growth.
In addition to developing its lead Cancer Metabolic molecule, they are looking to increase its breadth through co:development, partnering and acquisitions. The Head of Manufacturing (Chemistry, Manufacturing and Controls (CMC)) will be responsible for the companys activities for its ongoing early: and late:stage clinical trials. The successful candidate will be responsible for evaluation, selection and technical qualification of vendors, vendor management regarding production of clinical trial materials and future commercial products, overseeing studies required for high: quality regulatory submissions, and technical review of production documents. Strategic and tactical responsibility for implementing manufacturing strategy and strategic operational goals to exceed customer expectations for product quality, cost and delivery, maximizing efficiency, optimizing production levels and driving operational excellence. Work closely with internal and external key stakeholders, regarding technical support for activities, striving for best in class products and business practices to deliver to the customers expectations, managing teams and projects across the business. This position reports to the CEO.
Role and Responsibilities:
:Manage the supply of clinical and future commercial products in compliance with current Good Manufacturing Practices
:Ensure and maintain uninterrupted supply of clinical trial materials for all ongoing studies
:Communicate effectively to stakeholders
:Represent the CMC Team when communicating externally
:Create and maintain detailed CMC project plans to ensure clarity of deliverables and timing
:Provide support to Management in assessing resource needs to achieve timelines and quality milestones
:Develop tools and mechanisms for monitoring progress and problem solving with CMC project and functional area managers
:Manage day:to:day activities of external contractors carrying out cGMP activities
:Provide technical and management input into evaluation, selection and qualification of contract manufacturers and associated vendors
:Work with Quality Assurance to develop and use appropriate SOPs for vendor oversight, including external change control, deviations, investigations, and data review
:Provide technical support for Batch Record approval, review, and final release of product
:Ensure timely supply of API and Raw Material in support of Drug Product production
:Prepare and review applicable CMC sections for regulatory submissions
:Overall responsibility for Manufacturing activities
:Create and implement best practice manufacturing vision, strategy, policies, processes and procedures
:Ensure that manufacturing strategies and processes are in place to meet business objectives and operational needs in terms of price, quality and delivery targets
:Contribute to overall business strategy and annual budget process
:Take ownership of the manufacturing policy, guidelines and any associated documents
:Initiate and develop creative and innovative manufacturing processes
Required Skills:
:10+ years of experience in a pharmaceutical or biotechnology environment managing projects in CMC areas
:Minimum BS, MS, or equivalent in biology, chemistry, bioengineering, or related field
:Experience with managing contract manufacturers and associated vendors
:Strong working knowledge of cGMPs and other requirements fo


• Location: New Jersey, newark

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