Process Development Professional

4 days ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeProcess Full time
Senior Process Development Leader

We are seeking a seasoned Senior Process Engineer to join our Commercial Support team. This role offers an opportunity to lead technical initiatives and teams, contributing to development and leadership. The team is responsible for providing process and product support to drug product formulation and fill-finish operations.

Key Responsibilities:

- Provide technical expertise in sterile drug product unit operations such as formulation, vial filling, pre-filled syringe filling, lyophilization, and vial capping.
- Lead, coach, and develop a team of process development SMEs, fostering technical development and supporting team growth.
- Lead or contribute significantly to product and process investigations, including root cause analysis and product impact assessments.
- Act as a subject matter expert during change control, assessing the impact of proposed changes on the product and process performance.
- Support new product introductions (NPI), including recipe and protocol development, batch execution support, and troubleshooting.
- Drive continuous improvement initiatives to enhance process capability, reduce variability, and improve productivity.
- Analyze manufacturing data trends to identify opportunities for improvement and prevent potential issues.
- Review and approve GMP documentation such as SOPs, electronic batch records, and product technical documentation.
- Collaborate with cross-functional and global teams to ensure alignment and execution of strategies with potential for advancement in network roles such as Drug Product Team Lead etc.

What We Expect of You

We're looking for a senior-level engineer who brings strong technical expertise and is motivated to take on leadership responsibilities. You should be energized by problem-solving in a fast-paced environment and be comfortable making decisions based on data and sound technical rationale. You should have the ability to translate technical knowledge into clear risk-based decisions and communicate effectively across functions.

Basic Qualifications:

- Bachelor's or Master's degree in Engineering, Science, or related discipline with 6 years of experience in a similar role or PhD and 4 years of directly related experience.
- Demonstrated leadership skills with the ability to build teams and operate across functional boundaries both internal and external.

Preferred Qualifications:

- Typically 6+ years of drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling, or lyophilisation.
- Strong leadership capabilities with experience guiding teams or technical initiatives and supporting team development.
- Demonstrated experience in parenteral drug product manufacturing and delivery of cross-functional complex technical projects.
- Strong problem-solving technical skills related to parenteral drug product manufacturing.
- Thorough knowledge of GMP biotechnology manufacturing with significant understanding and knowledge of cGMPs. Experience with regulatory agency audits is beneficial.

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