The world's most revolutionary biopharma companies are partnering withAgilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.
Production Operating Manager:Establishes functional business plans and technical project objectives to meet the short- and long- term goals of the production organization. Manages employees and/or production departments in various manufacturing or product development support departments.Manages supervisors and/ or employeesresponsible for design/ implementation of production area processesDirects, manages resources to implement tactical business plans and department programs/ projects. Develops, implements solutions to department issues
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Oversees the chemical manufacturing and purification of oligonucleotide products according to customer specifications.
- Ensures product documentation is in compliance with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures.
- Provides day-to-day work direction to the Manufacturing Chemists concerning oligonucleotide production activities.
- Coordinates with Quality Control the submission, processing, and disposition of production samples.
- Maintains analytical results for use throughout product campaigns.
- Works with manufacturing management to determine the feasibility of new projects.
- Assists manufacturing management with the transitioning of processes from R&D and other functions toManufacturing.
- Ensures the effective use of material, equipment and personnel in producing quality products.
- Helps to formulate and makes recommendations with regards to manufacturing Standard Operating Procedures and GMP practices.
- Ensures appropriate product and process change controls, deviations and corrective and preventive actions are implemented as required.
- Troubleshoots manufacturing problems, develops and implements continuous quality improvements.
- Initiates the development of new processes as requiredto resolve manufacturing issues.
- Establishes operating procedures and specifications, improves upon existing methods and techniques, and provides guidance for quick resolution of technical issues.
- Pursues activities for the ongoing streamlining and improvement of production processes, and associated support processes.
- Sets-up, coordinates, and at times, conducts experimentation with new techniques and materials for evaluation of product and process improvement.
- Coordinates with vendors to ensure the on-going consistency and suitability of their materials used in Agilent products.
Bachelor's degree (or equivalent work experience) in chemistry, biology, or related life sciences field;
8 + years related experience and/or training; or equivalent combination of education and experience.
Prior experience in cGMP compliance facility required.
KNOWLEDGE, SKILLS, AND ABILITIES:
* Knowledge of GMP manufacturing processes and methods for cost-reduction, mass balance calculations, quality improvements, yield improvements and manufacturing efficiency.
* Knowledge in the fields of Science and Engineering; being able to apply these concepts to define problems, collect data, establish facts, deal with concrete and abstract variables, and draw valid conclusions.
* Ability to manage multiple tasks and priorities, and establish short and long-term planning horizons to complete these duties.
* Ability to work effectively as a team to accomplish deadlines and objectives, yet make independent decisions on various tasks.
* Knowledge of HPLC, HPLC-MS, GC, and UV analysis desiredalong with familiarity in the manufacturing of oligonucleotides.
* Knowledge of cGMP guidelines as well as international regulations pertaining to the production of APIs and drug products.
* Technical knowledge of assays utilized for the testing of oligonucleotide APIs and raw materials.