A day in the life of our Senior Manager R&D – Product Development
Manages and motivates a team of scientists and manufacturing personnel in the development and manufacture of inhaled drug delivery systems, including dry powder inhalers and pressurised metered-dose inhalers (pMDIs).
Responsible for identifying Critical Process Parameters (CPPs) through Design of Experiments studies and developing robust manufacturing processes.
Develops strategy for manufacturing processes from concept through scale up to commercialisation. Use Quality by Design (QbD) and Quality Risk Management (QRM) principles; critically reviewing data and making recommendations.
Responsible for delivering R&D manufacturing workplan on time in compliance with cGMP requirements. Overall responsibility for housekeeping / improvements in GMP work centres.
Key contact for process technical transfers to commercial partners and pre-submission process validations manufacturing.
Responsible for keeping abreast of latest manufacturing technologies, drive efficiencies, improve process yields and lower cost of goods.
Responsible for delivering on Module 3 sections assigned for Regulatory submissions.
Responsible for identifying headcount and budget requirements for the process group.
Work as an integral member of a larger team alongside Formulation and Material Science teams.
Who we are looking for
Are you?
• Bachelors, Masters or PhD (or equivalent) qualification in physical sciences, Engineering (or related subjects)?
Experienced in the Pharma (Highly desirable) industry or in a regulated environment with a minimum of 5 years’ industry experience?
Do you have?
Direct experience managing teams, setting goals and defining development plans.
Direct experience managing projects developing manufacturing processes for manufacturing of complex products.
Demonstrated project management skills and the ability to effectively function in a fast-paced, dynamic technical environment.
Use of QbD principles and QRM in project execution.
Knowledge of global regulatory and compliance requirements.
First-hand experience of GMP environments is strongly desirable.
Good planning and organising skills & adaptable to changing priorities.
Excellent verbal and written communication, organizational and computer skills.
