Description:
The Process Development Manager/Sr. Engineer – will report to the Sr. Manager Process Development for New Product Introduction (NPI) Technical Delivery and will be responsible for technical delivery of NPIs and life cycle management (LCM) products to ADL. The successful candidate will have at least five to ten years of experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading tech transfers and process validation activities as well as managing teams.
JOB SCOPE:
This role will require the candidate to manage a team of tech transfer engineers/scientists as well as lead tech transfers of NPIs and LCMs to ADL. The candidate will provide technical support to large molecule and small molecule drug product manufacturing at ADL as well as part of the global Process Development (PD) organization. The input provided will also include support of process performance and implementation of process improvement strategies and will include the following:
- Leads new product introductions and lifecycle changes into the vial and syringe plants from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.
- Manage a team of tech transfer engineers/scientists supporting other vial and syringe transfers to Dun Laoghaire.
- Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as and when required.
- Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
- Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
- Develops and characterizes drug product processes and transfers technology to commercial drug product sites.
- Identifies and implements operational opportunities for current and new sterile operations.
- Troubleshoots issues with drug product processing technologies and equipment.
- Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
- Development of validation plans, process performance qualifications (PPQs) for vial and syringe filling.
- Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
- Participate and lead in validation cross functional teams at the site to ensure adherence to required policies and procedures.
- Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
BASIC QUALIFICATIONS:
- A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 to 10 years’ experience in a similar role OR Master’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills