Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries HealthTronics Inc. and Qualitest Pharmaceuticals, please visit www.endo.com.
The Senior Process Scientist/Engineer-Technical Operations will interact with internal and third party manufacturers to provide technical support during process development, scale-up, technology transfer and commercialization; support supply chain working to assure uninterrupted product supply.
To accomplish this you must:
Manage as well as participate in manufacturing and project teams; interact with peers at Endo including supply chain, QA, RA, R&D, and project management, and third party manufacturers to insure reliable commercial supply and advance projects in a timely and cost effective way while maintaining quality
Work with ANDA and NDA Technical Operations to ensure manufacturability of new products as they advance through process development, scale-up, technology transfer, validation, and commercialization
Independently identify, prevent and solve technical problems (e.g., manufacturing issues, product quality issues, customer complaints, etc.)
Review technical documents and CMC compilation to support development, submission, and ongoing manufacture
Identify, evaluate, and select new contract manufacturing partners. Manage technology transfer to new suppliers, as required
Participate in budget planning and financial assessments. Perform cost of goods calculations and make recommendations based on the business objectives
Domestic and international travel up to 25% is required
Budget management as directed and required
This position requires a BS in Chemical Engineering, Chemistry, Pharmacy or related scientific field along with a minimum of 5 years relevant experience in the pharmeceutical industry or related field. This person must have familiarity with cGMP, DEA, and FDA regulations and SUPAC and ICH guidelines. This position requires an understanding and experience with pharmaceutical manufacturing processes and equipment; sound experience of various dosage formulations; experience implementing and evaluating contracted work with vendors and suppliers and maintaining successful partnerships.
The skills, knowledge and abilities necessary to be successful in this role are:
Process development, technology transfer and scale-up, technical writing, strong communication and inter personal skills, and analytical thinking and problem solving
Risk assessment, Risk management and statistical process control a plus
Able to work well in a team-oriented environment
Critical thinking and problem solving, results oriented, decision making, team building and motivating the team to action
Able to influence others through indirect means.
Able to organize, prioritize, and successfully complete multiple projects, tasks, and issues in a timely manner
Functions independently in periods of supervisorís absence.
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