Job title: Expert Science & Technology
Company: The Medicines Company
Job description: Job Description Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries into therapeutics for millions of patients. YOUR KEY RESPONSIBILITIES: Your responsibili
Job Description Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries into therapeutics for millions of patients. YOUR KEY RESPONSIBILITIES: Your responsibilities include, but are not limited to: . Plan and support development of early and late phase NCE development for parenteral dosage forms (including poorly soluble compounds). . Plan and support entire drug product development process starting with first pre-formulation studies up to the manufacturing process transfer to production and the provision of the required documentation to allow worldwide registration . Support development of robust formulations and processes through optimization, scale-up and validation work applying QbD principles incl. risk assessments and DoEs . Strong scientific background wrt biopharmaceutics and its application in DP development . Provide documentation of raw data, evaluation and contribute to interpretation of results. Provide input for the selection of next experiments. . Communicate and address problems, perform safety and literature searches under guidance from more experienced team members. . Meet quality, quantity and timelines in all assigned projects. . Perform and document scientific experiments [#video#https://www.youtube-nocookie.com/embed/Mo1vwtVPVA0{#400,300#}#/video#] Minimum requirements WHAT YOU’LL BRING TO THE ROLE: . M.Pharm with 8 to 10 years of experience or PhD in Science with focus on pharmaceutical sciences and technology (e.g. Pharmacy, Chemistry) with 4+ years of experience . Experience in the development, scale-up and technology transfer of Parenteral Drug Product manufacturing processes is required. . Background in aseptic process development of injectable solutions and suspensions is required . Thorough understanding of aseptic fill-finish unit operations (i.e. filling, filtration, mixing, lyophilization etc.) and equipment for scale-down model development and process characterization is required. . Experience with regulatory filings (IND/IMPD etc.) is required. . Representation of Pharmaceutical Development as formulation project leader in global CMC teams, functional representative in cross-functional teams . Evaluation and implementation of new methods and technologies, scientific contributions, supervision of research projects and initiation of new research activities . Demonstrated competency and experience in drug product development within the pharmaceutical industry is required. . Successful work experience in a matrix organization is preferred. . Good oral, written (good experience in writing of scientific reports and filing documentation) and presentation skills are essential. Why consider Novartis? 799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. Imagine what you could do at Novartis! Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusion workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
Expected salary:
Location: Hyderabad, Telangana
Job date: Sun, 26 Dec 2021 23:28:28 GMT
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