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Organon - Associate Principal Scientist External Manufacturing Support-API/Drug Substance (BB-B9919)

Gefunden in: Xpatjobs CH

Beschreibung:
Job DescriptionSeeking an exceptional candidate for a technical leadership position within the Analytical Sciences Science and Technology organization. The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from Active Pharmaceutical Ingredient (API) & Drug Product (DP) routine support tp driving efficiency gains across the global supply operations network. The incumbent will be expected to interact closely with the external Contract Manufacturing Organization sites across the Manufacturing network in identifying, developing, implementing, and troubleshooting laboratory test methods, technologies and workflows as well as material for ensuring compliant, robust, and responsive supply. The individual will have a deep understanding of the technical, regulatory and business environment needs related to API (and/or DP) development and commercial supply and provide critical analytical support to ensure success.Responsibilities include:Author analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.Perform investigations with innovative technical troubleshooting skills and assist in developing/implementing Corrective Action and Preventive Actions.Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends.The candidate will also be responsible for technical training of staff, as needed, on analytical techniques and problem solving. In addition, the incumbent will keep up with API and DP regulation changes and help facilitate cross company communication to influence implementation strategies.The position will report into the Director guiding the External Manufacturing group. A strong technical background with a superior problem solving skill set, exceptional leadership abilities, strong knowledge of Current Good Manufacturing Practice and Data Integrity are considered essential, as these will be key attributes necessary to facilitate the ability to influence change in efforts to realize sustained, compliant supply of products to our patients.Position Qualifications: Education Minimum Requirement: Ph.D. with at least 3+ years ORBS/MS with at least 8+ years of experience in analytical development or commercial supply support for API and/or drug product.Required Skills and Experience:Have working knowledge of API and Drug Product commercial quality control testing.Have a working knowledge of various analytical techniques (e.g., chromatography, dissolution, spectroscopy) and the application of specifications to support drug substance and drug product development and registration.Have working knowledge of process by which the products are brought to and maintained on the marketWorking with Contract Manufacturing Organizations and Clinical Research Organizations.Have working knowledge of Capital Management Committee filing requirementsWorking with cross-functional teamsDemonstrate strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different culturesSelf-motivated to take ownership and accountability of issues and drive them to completion.Ability to speak up and raise issues and help to drive to resolution.Ability to quickly adapt to changes and develop appropriate plans for managing risks.#NewCoResidents of Colorado to request this roles pay range.Who we are Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Womens Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.Our Vision is clear: A better and healthier every day for every woman.At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.NOTICE FOR INTERNAL APPLICANTSIn accordance with all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your

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