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Sr. Manager,Technical Operations and Contract Manufacturing

Company: Assertio Therapeutics, Inc.
Location: Lake Forest
Posted on: March 26, 2019

Job Description:

JOB SUMMARYResponsible for commercial contract manufacturing activities at Contract Manufacturing Organizations (CMOs). This role will provide manage the technical aspects of Pharmaceutical Process, Manufacturing and Packaging activities with a focus on commercial product manufacture. Contributes to the overall strategy and planning to support tech transfer, launch, post-approval changes and routine commercial manufacturing activities and will have experience in CMO management in a development and commercial cGMP environment. ESSENTIAL JOB FUNCTIONS--- Manages and oversees tech transfer, launch, post-approval changes and routine commercial manufacturing activities at CMOs. --- Oversees and plans product needs to ensure timely supply. Assist in preparation schedules and coordination of manufacturing activities.--- Technical Subject matter Expert in Assertio's products with emphasis in process and manufacturing activities. --- Helps create a manufacturing strategy for Assertio's products, interfacing with Quality, Clinical, and Regulatory groups.--- Writes/reviews batch records and protocols for manufacturing of drug products.--- Writes /reviews development and validation technical reports --- Oversees clinical trial material manufacturing and packaging activities and manages budgets for those projects.--- Works with Quality Systems to ensure implementation and maintenance of quality standards, meeting compliance/regulatory requirements.--- Supports manufacturing investigations and regulatory submissions.ADDITIONAL RESPONSIBILITIES/DUTIES --- This position will require up to 35 % travel to contract manufacturing facilities in the US and ex-US. RequirementsEDUCATION AND EXPERIENCE --- BS or equivalent in Chemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field. An advanced degree in sciences would be a plus.--- 4-7 years of solid dose manufacturing experience at a manufacturing plant with 2-3 years of CMO management experience preferably in a virtual environment. --- Experience in clinical manufacturing, late-stage development, process validation and commercial pharmaceutical cGMP manufacturing environment.--- Good troubleshooting skills in various facets of process engineering, validation engineering, technology transfer, scale-up operations. --- Experience with High shear granulation, fluid bed granulation and drying, extrusion and hot-melt extrusion technologies.--- Ideal candidate will be highly cross functional and collaborative with internal and external partners.--- Experience with serialization, life cycle management of current marketed commercial products, has managed manufacturing and supply of drug product to both US and ex-US markets.SKILLS AND ABILITIES--- Solid problem-solving, troubleshooting and organizational skills --- Strong knowledge of pharmaceutical cGMPs.--- Experience in leading cross-functional CMC teams to accomplish department goals--- Effective communication skills (verbal, written, interpersonal, organizational), capable of setting priorities and managing high workload projects--- Familiarity with risk management strategiesAbout UsTHE COMPANYAssertio Therapeutic is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of neurology, orphan and specialty therapies.Assertio has a clear THREE PILLAR strategy for growth:MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company's strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.Assertio is an AA/EEO/Veterans/Disabled employer.

Keywords: Assertio Therapeutics, Inc., Janesville , Sr. Manager,Technical Operations and Contract Manufacturing, Executive , Lake Forest, Wisconsin

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