Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Gathers, stages and returns production materials in support of manufacturing activities. Assists team members with equipment assembly, cleaning, and storage as required to support manufacturing. Maintains cleanliness of manufacturing equi

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Assist PK/BE team in reviewing literature and summarizing important information . Learn and inform novel research methodologies in pharmacokinetics and bioequivalence studies. Assist PK BE team in organizing and maintaining project specif

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Assist PK/BE team in reviewing literature and summarizing important information . Learn and inform novel research methodologies in pharmacokinetics and bioequivalence studies. Assist PK BE team in organizing and maintaining project specif

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Assist in the collaboration with necessary business partners to develop CSV documentation required by ARI policy based on project assignments. Assist with the review of the department SOPs and validation documentation for GxP systems. Gat

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Obtain regulatory documents and initiate eCTD compilation using templates, publishing tools and publishing software. Prepare high quality regulatory submissions for multiple programs/products in development (e.g. IND, NDA, ANDA, and VMF)

Duties Coordinate Chemistry Laboratory testing to ensure that all required samples (raw materials, in process, and finished products) are received and tested. Monitor laboratory activities and achieve a smooth and timely operation. Conduct quality control tests. Communicate and give guidance to chemists and technicians where required. Maintain an adequate supply of invent

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Manage Formulation Development for New Products. Provide technical leadership for the design and execution of Quality by Design (QbD) product development studies and development of scalable manufacturing process for parenteral drugs. Mana

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Manage Preventative Maintenance/Calibration/Repair Program Prepare, maintain, and follow procedures for the maintenance, calibration, and metrology systems and associated processes to adhere to cGMP's, company, local and state requirement

The ideal candidate is someone who understands employee experience and engagement, is a self starter, and has strong writing, editing, and review cycle skills. The candidate should be able to simplify complex topics and identify the important points of information gathered from multiple sources, turning them into great storytelling for diverse audiences. Nothing in this j

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform manufacturing and development activities within a cleanroom environment. Cleans and stores manufacturing equipment and areas as required to support manufacturing activities. Sanitization/disinfection of components, materials and p

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Lead the development, optimization and validation activities of analytical methods for multiple projects simultaneously. Analyze and review project data and report for multiple projects in support of research and development for small mol

Performs inspection of vial, ampoule, and syringe containers by hand (manually). Accurately completes all documentation associated with tasks performed. Keeps work area clean and orderly. Follow directives issued by leads and supervisors. Adheres to good manufacturing practices, (GMP & cGMP). Perform duties according to the company's standard operating procedures, (SOPs).

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Provide effective leadership including individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communicating effectively, planning an

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Stocks, gathers and stages manufacturing supplies and equipment. Gathers, stages and returns production materials as required to support manufacturing activities. Cleans and stores manufacturing equipment and areas as required to support

Performs duties required in the washer/capper area to established standards of productivity and quality as per standard operating procedures. Adheres to good manufacturing practices, (GMP & cGMP). Perform duties according to the company's standard operating procedures, (SOPs). Operates washer and capper machines used in department. Accurately counts work done and keeps ne