Mylan Pharmaceuticals Inc
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:
Provide overall technical ownership of the product performance and health of assigned products and product families, with a focus on technical investigations. Provide tactical oversight to support strategic initiatives from upper management. Coordinate with unit operations, Quality, Manufacturing Technical Services, and other technical services regarding the product health and performance.
Partner with unit operations to provide guidance to employees in the Manufacturing assigned products or product families. Maintain product performance history of the products throughout the entire commercial lifecycle.
Complete manufacturing investigations and generate associated Corrective Action and Preventive Action (CAPA) items for review and prevent recurrence.
Collect and track metrics to align with business objectives (Right First Time, Yield, and Rejections). Provide guidance on product problems that occur on the shift and tactical oversight. Support strategic initiatives from upper management in the areas of schedule adherence, “Right First Time,” cycle time reduction, and all other
Operational Excellence initiatives.
Continue to evaluate product health and performance (including trends). Drive continuous improvement efforts and participate in validation and CPV activities.
Participate in complex investigations and relevant annual product reviews and supervise all activities within assigned area including overseeing Production, Maintenance and Quality employees and ensuring that SOPs, cGMPs, safety rules and OSHA regulations are observed throughout the plant. Identify and resolve technical issues.
Represent products or product families at Quality Council. On a daily basis, while on the manufacturing plant floor, identify and communicate to upper management the opportunities to improve site operations in the areas of Quality, Cost, Delivery and Safety. Ensure that all Quality standards are adhered to and work closely with
Acceptable Quality Level (“AQL”) management to remediate any issues that arise on shift.
Perform job functions in accordance with all applicable SOPs, federal and state laws, OSHA guidelines, health authority regulations and departmental processes.
- Company Name
- Mylan Pharmaceuticals Inc
- Morgantown, WV
Bachelor’s degree or equivalent in Chemical Engineering, Chemistry, Biomedical Engineering, Pharmaceutical Sciences, Pharmaceutical Manufacturing or a related field, and 3 years of experience in the position offered or related position, including 3 years of experience with Manufacture of modified release and multi layered beads, pellets, and tablets – specifically utilizing Fluid Bed Wurster and Rotor coating systems to apply aqueous and solvent based coating; Practices and procedures used in manufacturing systems involving fluid bed processing of High Potent and CII – CIV products; Writing manufacturing/analytical investigations for modified release dosage platforms, CAPA, and experimental manufacturing protocols; Product Validation and CPV activities involving CpK and PpK calculation and statistical analysis with Minitab software; Manufacture of complex dosage forms for domestic and international markets; Identifying critical material attributes (CMAs) and critical processing parameters (CPPs), link the CMAs and CPPs to critical quality attributes (CQAs).
Please send resume to Mylan Pharmaceuticals Inc. at www.mylancareers.com.
- How to Apply