Applications are invited for the Fixed Term (12 month) position of Lead Process Engineer I within the Process Development Group. Reporting to the Associate Director, Process Development the successful candidate will provide technical expertise and leadership for new and existing technology based product development programmes.
- Manage experimental programmes for use in process development activities, involving investigational studies to provide indicative process/analytical data for identification of critical process parameter effects. Analyse the process and analytical data generated by these programs and report on same.
- Design and lead process development activities focused on study of critical parameters to ensure that process conditions, at all scales, are consistent and not at “edge of failure”. Select appropriate parameters for prototype/finished dosage production to ensure product quality and reproducibility are achieved and a robust control strategy is developed.
- Develop, execute and refine the methodology required for the generation of successful scale-up/optimisation process models. These models are required to accurately establish process operating windows at relevant scale and identify appropriate in-process operating ranges to maintain both product quality and production efficiency.
- Execute all aspects of team management as a leader of projects, from development through launch, associated with new formulation product or technology development programmes.
- Interact with cross functional and cross site technical and CMC teams influencing and communicating on development projects.
- Assess industry process advancements and introduce them to site as appropriate.
- Act as site expert in resolution of technical issues by means of formulation, process or machine modifications, providing innovative solutions to issues at hand.
- Manage and lead relative areas of responsibility through FDA pre-approval and post-approval inspections by serving as technical expert for development and processing operations.
- Prepare Development Reports and CMC sections of DMFs or NDAs related to formulation development, process scale-up, process control and comparisons of development and commercial processes.
- Ensure all company and departmental policies and procedures are adhered to and develop new or enhanced systems where appropriate.
- Third level qualification in a Science or Engineering Discipline (to level 8 or higher) with minimum 5-8 years relevant experience.
- Experience of process development/engineering, formulation and related commercial scale-up/manufacturing preferably in the pharmaceutical industry.
- Strong technical and project management skills.
- Demonstrated track record in generating technical options to resolve problems, prioritising solutions, selecting optimal solutions and implementing decisions in the pharmaceutical industry.
- Strong experience in statistical analysis, sample sizing, Anova, DOE, regression analysis an advantage.
- Excellent verbal and written communication skills.
“Alkermes provides equal employment opportunities to all employees and applicants for employment”