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 Senior/Principal Process Development Engineer for our Durham, NC location.
The Senior/Principal Process Development Engineer will be responsible for supporting process development and leading process optimization, scale-up and validation 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 Senior/Principal Process Development Engineer will also assist in the oversight of cGMP manufacturing of GMP clinical trial supplies and in supporting Analytical Development activities as needed. In addition, the role is responsible for drafting, reviewing and approving key quality management system documents and analysis for process improvement and failure reduction activities.
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Essential Duties & Responsibilities:
This position will be responsible for supporting the transition of drug product manufacturing processes from the R&D formulation development phase through process optimization and scale-up for technology transfer from Phase 1 through Commercial development; and for developing and managing GMP manufacturing facilities, associated equipment and utilities. This will include the manufacture of phase 1 and 2 clinical supplies including participating in and leading the production of supplies for clinical development. This position will be responsible for evaluating and developing modern manufacturing techniques (ex., semi-automated and automated processes, etc.) to produce modified release ophthalmic implants. The position may support both aseptically manufactured and/or terminally sterilized products.
This position will work closely with the Formulation and Device Development, Quality Assurance, non-clinical development, Clinical, Regulatory, and Material Sciences/Analytical functions; and provide support for third-party manufacturing and testing services vendors.
The Senior/Principal Process Development Engineer will also write and review Chemistry, Manufacturing and Controls (CMC) documents, including development protocols and reports, Regulatory Submissions, 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 GMP facility development, maintenance, and operations.
- Responsible for developing and maintaining GMP Quality Management systems related to GMP manufacturing processes, facilities, utilities, equipment, and materials.
- Responsible for leading process optimization and validation of manufacturing processes.
- Responsible for material sourcing, material management, equipment tooling, equipment management
- Support the development of SOPs, IQ/OQ/PQ Protocols and Reports, and other documents related to pharmaceutical development and manufacturing activities.
- Develop and 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 clean room operating conditions for sterile products, maintaining clean room logs/documentation, and 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.
- Communicate project status and concerns to supervisor and project leadership.
- Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs.; Assoc.+9 yrs.; M.S.+5 yrs.; PhD +2 yrs.)
- The ability to fluently read, write, understand, and communicate in English.
- 5 Years of Relevant Experience
- Small Molecule Drug Process Development experience is required.
- GMP Manufacturing equipment and process validation experience is required.
- Experience working in classified manufacturing spaces (ISO5 or ISO 7; Or Class A/B or Class C) is required.
- An understanding of U.S. and/or EU GMP regulatory requirements, regulatory standards and guidance related to clinical development or U.S. and/or EU regulatory requirements for commercial GMP manufacturing of Drug Products or Drug Led Combination Products (EU or US Requirements) is required.
- Good written and verbal communication skills are required.
- In-depth knowledge of GMP Compliance requirements for Manufacturing facilities, utilities, and equipment for the production of Drug Products and/or Drug Led Combination Products (EU or US Requirements) is highly Desired.
- Hands on experience using hot melt extrusion, injection molding or materials characterization equipment is a plus.
- Experience with sterile products preferred.
- Benefit from working in a highly collaborative environment.
- Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
- Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!
- Travel Requirements: 10 %
- Relocation assistance: No
- Sponsorship available: Yes
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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.