Executive, Formulation & Development Injectable

You should have a good understanding of product development activities for various injectable dosage forms intended for the regulated market, including general injectable and onco products. Knowledge of ANDA and 505b2 product filing is essential. Familiarity with a wide range of dosage forms such as liquid solution, lyophilized, suspension, and emulsion is required. You should also be well-versed in drug device combination products and understand regulatory expectations. Experience with equipment like high shear homogenizer, high pressure homogenizer, lyophilizer, microfluidizer, and nano mill is preferred. Your responsibilities will include preparing and reviewing product development reports, master formula records (MFR), stability protocols, study protocols, and standard operating procedures (SOP). You should have a basic understanding of Quality by Design (QbD) principles for formulation development, including Quality Target Product Profile (QTTP), Critical Quality Attributes (CQA), Critical Process Parameters (CPP), Critical Material Attributes (CMA), risk assessment, and control strategy. Knowledge of various Quality Management System (QMS) documents like change control, incidents, planned deviations, and unplanned deviations is necessary. A fundamental understanding of API specifications, Drug Master Files (DMF), excipient specifications, in-process specifications, finished product specifications, and shelf-life specifications of injectable products is expected. Additionally, you should be familiar with the preparation and review of necessary documents required for ANDA submission and product approval. Your skills and expertise should be at an advanced level in formulation development for solution-based injectables, while scale-up and process optimization, material science and excipients selection, CoA & analytical data review, and technical troubleshooting should be at an intermediate level. Regulatory affairs and compliance skills are expected to grow over time, along with cross-functional coordination, stability testing, protocol development and documentation, and cross-functional collaboration. Investigation & CAPA management is also at an intermediate level. Qualifications: - M Pharm Amneal is an equal opportunity employer that values diversity and inclusion. The Human Resources team at Amneal plays a crucial role in partnering with all aspects of the organization to drive success through effective people management. They provide high-level input at a strategic level, ensure legal compliance and best practices, offer support and advice to meet organizational objectives, provide expert guidance on workforce management and employee relations, and keep the organization informed about developments impacting employment matters.,