CAREERS
| R&D Process Development Scientist III |
| Date: December 21, 2011 |
| Reporting To:Head of Formulation |
| Department:Research & Development (R&D) |
| Location:Inverin, Co. Galway, Ireland |
ESSENTIAL DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the
essential duties.
- Development of commercially viable Sterile injectable drug product manufacturing processes (vials and pre filled syringes).
- Perform laboratory studies to support nomination of Injectable formulations and packaging for the main unit operations of Compounding, Filtration, autoclaving, preparation and machinability of components (e.g. vials, closures, syringes);
- Apply scientific/engineering principles to support process scale up from lab to manufacturing plant.
- Design experimental protocols and run pilot scale processes/development trials at laboratory and pilot scale.
- Technical transfer to manufacturing plant and run process evaluation/registration batches
- Support scale up for commercial product launch.
- Supporting introduction of new process technology/equipment to product development and production.
- Sourcing of new packaging components (vials, closures, prefilled syringes) and assessing machinability suitability for sterile processes.
- Preparation of batch documentation for GMP sterile manufacture.
- Technical report writing for process development input to global regulatory submissions.
- Ensuring safe working practices in compliance with company policies.
- Familiar with GMP and quality aspects for sterile product manufacture.
- Work cross functionally with counterparts in other departments (Analytical, Quality, manufacturing, Microbiology and Regulatory).
- Provide clear communications at team level.
- Assess unit operations, technology for sterile product manufacture.
- Provide technical input to production site.
- Perform other duties as assigned.
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
KNOWLEDGE
Development of injectable solutions with technical expertise in the following areas;
- Practical experience with manufacture of sterile products.
- Knowledge of unit operations from preparation of vials/stoppers, compounding, filling and sterilization.
- Ability to identify scientific/engineering solutions for development of processes and scale up from lab, pilot plant to commercial scale.
- Application of scientific/engineering principles to support development & scale up of manufacturing processes.
- Microbiological fundamentals and knowledge of unit operations to secure sterility (e.g. defining F0 cycle, Autoclaving, aseptic techniques and other terminal sterilization processes).
- Familiar with principles of sterility control GMP and Quality requirements for sterile pharmaceutical product development and manufacture.
- Working knowledge of QbD, Right First Time and process capability.
SKILLS AND ABILITIES
In addition to technical skills.
- Track record of delivering products.
- Capability to set clear goals and manage multiple tasks.
- Excellent communication skills (verbal and written).
- Basic knowledge of statistics.
- Proficient computer skills (Excel, word, powerpoint, databases).
SUPERVISION
Position functions autonomously reporting directly to the Head of Formulation.
EDUCATION/EXPERIENCE
Minimum of a scientific Bachelor's degree (Engineering/Physics/Chemistry/pharmaceutical sciences) with 4-5 years’ experience in the development or manufacturing of sterile products or MSc with a minimum of 3 years’ experience in the development or manufacturing of sterile products.However, a combination of experience and/or education will be taken into consideration.
However, a combination of experience and/or education will be taken into consideration.
LICENSES/CERTIFICATIONS
None.
LANGUAGE SKILLS
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
MATHEMATICAL SKILLS
College level mathematics ability required (e.g. Statistical knowledge for data interpretation and planning experiments).
REASONING ABILITY
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms to lift and scoop. May be required to lift or maneuver boxes or containers using lifting equipment, as well as physically pushing, rolling or lifting. May be required to wear personal protective equipment including but not limited to: respiratory protection, safety glasses, hearing protection, safety shoes and protective clothing. Medium lifting requirements.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Predominantly laboratory/Pilot laboratory, commercial production plant and office environment.
TO APPLY
All applications should be forwarded to careers@bionichepharma.com
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