Principal Process Development Engineer

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon and we are looking for a Principal Process Development Engineer for our Durham, NC location. 

Job Description

The Principal Process Development Engineer will be responsible for supporting process development and leading process optimization and validation of manufacturing capabilities for modified-release, ophthalmic products from early pre-clinical development through clinical development, and commercial release. This position will be responsible for GMP facility maintenance, operations, systems qualification, and for supporting quality management systems. The Principal Process Development Engineer will also assist in the oversight of cGMP manufacturing of clinical materials and in Analytical Development activities as needed. The role includes drafting, review and approval of key quality system documents and analysis for process improvement and failure reduction activities.

Essential Duties & Responsibilities:

This position will be responsible for supporting the transition of drug product manufacturing processes from the R&D formulation development group through process optimization and scale-up for technology transfer. The role will also support manufacture of phase 1 and 2 clinical supplies including participating in and leading the production of current Good Manufacturing Practice (cGMP) supplies for clinical supplies.  This position will be responsible for evaluating and developing modern manufacturing techniques to produce modified release ophthalmic implants such as injection molding, micro-molding and extrusion techniques. The Principal Process Development Engineer may support both aseptically manufactured and terminally sterilized products.

This position will work closely with the Quality Assurance function, R&D non-clinical function, Clinical, Regulatory, and Analytical functions.  Provide support for drug product manufacturing and testing activities conducted by third-party manufacturers (CMOs) and vendors.

The Principal Process Development Engineer will also write and review Chemistry, Manufacturing and Controls (CMC) documents, including development protocols and reports, and maintain compliance with cGMP standards as appropriate for pre-clinical and clinical development.

Accountabilities

•    Responsible for the support of development, tech transfer, and qualification of manufacturing processes for sterile drug products used in non-clinical and clinical development
•    Responsible for leading process optimization and validation of manufacturing processes.
•    Responsible for GMP facility maintenance, operations and supporting quality management systems.
•    Responsible for material sourcing, material management, equipment tooling, equipment management
•    Support the development of SOPs, IQ/OQ/PQ Protocols and Reports, and other documents needed for pharmaceutical development and manufacturing activities, including GMP equipment 
•    Schedule routine preventive maintenance and repair activities on facility and equipment, including, routine cleaning, maintenance and environmental monitoring of ISO 7/8 clean room facilities and equipment
•    Routine verification of ISO 7 and ISO 8 clean room operating conditions, maintaining clean room logs/documentation, and maintaining clean room supplies
•    Develop and maintain state of the art knowledge of drug product manufacturing and development technology (e.g., extrusion and micro-molding techniques) and the associated regulatory requirements for GMP production
•    Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs)
•    Support the execution of CMC project plans and timelines to ensure all projects are appropriately prioritized and key goals are met on time and within budget
•    Production preparation by reviewing production schedules; studying and clarifying specifications; calculating requirements; assembling and weighing materials/supplies and assisting with supply chain logistics.
•    Document production by completing forms, reports, logs, and records of equipment and batches
•    Communicate project status and concerns to supervisor and project leadership

Key Requirements/Minimum Qualifications:

• Bachelor’s Degree or Equivalent years of direct