Pharma Operations Lead - MDI Manufacturing & Compliance

Plan, organize and oversee all activities related to the manufacturing and packaging of MDIs to include batch planning, operations, troubleshooting and shift personnel management. Review and compile the documents generated during the production of MDIs such as batch records and protocols (i.e. validation protocols, qualification protocols, etc.). Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing and packaging operations. Evaluates various stations of the production operation to ensure optimum efficiency and follow through. Initiate and review written procedures such as standard operating procedures (SOPs), operating instructions, cleaning procedures, safety procedures, and other work procedures as needed. Work with Integrated Product Development (IPD)/R&D on the execution of bio-batches (abbreviated new drug applications - ANDA) and validation batches. Coordinate with departments such as Quality Assurance (QA), Quality Control (QC), Research & Development (R&D), Maintenance & Engineering, Supply Chain and Warehousing, Human Resources, and other internal functional partners with respective to the completion of quality work and achieving the production schedules and performance objectives. Ensure the process flow of raw materials, supplies, and other resources. Provide daily supervision and support to operators in daily production activities such as trouble shooting and other work tasks. Follow production schedules, ensures quality standards, and handle technical and administrative issues on assigned shift. Maintain communication between employees and upper management to ensure procedures and policies are understood. Assist with recruiting, hiring, training, motivating, and evaluating the performance of a diverse manufacturing team. Manage performance and train assigned employees using Company systems, procedures, policies, practices, and other tools to meet established performance standards, productivity targets, and overall business requirements. Produces requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures. Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs. Documents production by completing forms, reports, logs, and records of equipment and batches. Update job knowledge by participating in training opportunities. Maintain accurate and clear documentation that proves that manufacturing is being carried out in accordance with both internal and external quality systems or regulations. Keep maintenance logs for all of the machines or processes they oversee, which requires proficiency in word processing and spreadsheet software. Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment. Other duties as assigned. Education and Experience: Bachelors degree in Pharmaceutical engineering, Pharmaceutical Sciences or related field of study from an accredited college/university required. Masters degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred. 1-3 years of direct work experience in pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Understanding of machines used in pharmaceutical manufacturing. Capable of conducting troubleshooting, investigations and root cause identification and analysis. Capable of handling and participating in compliance and regulatory audits at the local and federal levels. Must be proficient in computer skills and software applications such as Microsoft Office tools. Experience using SAP business system and applications is a plus. Experience in Inhalation products (MDI) is a plus. Professional and Behavioral Competencies Proficiently speak English as a first or second language Ability to understand and analyze complex data sets. Knowledge of statistical packages is a plus. Knowledge of good manufacturing practices and good documentation practices preferred. Ability to read, write and communicate effectively. Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously. Excellent organizational skills with the ability to focus on details. Basic computer skills (Word and Excel) Intermediate Good basic math knowledge and excellent attention to details. Work Schedule and Other Position Information: Must be willing to work in a pharmaceutical manufacturing setting. Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs. Must be willing to work some weekends based on business needs as required by management. No remote work available. No employment sponsorship or work visas. #J-18808-Ljbffr Jobskey