Leading Biopharma Client in Cork have a requirement for a Associate Director of Drug Substance for their biopharma startup facility. Excellent career opportunity and benefits package
- The Biologics Drug Substance operations team requires an experienced Drug Substance Operations Lead. This role will lead the Operations team to successfully manufacture and supply quality pharmaceutical products in meeting the Manufacturing Division. Priorities of: Compliance, Supply, People, Strategy and Profit Plan.
- The leadership style is one of collaboration, coaching and facilitating the IPT team to become a high performance organisation. This will require a substantial amount of his/her time within the IPT process, engaging and communicating with all IPT members, especially important as the team will double in size as the facility enters commercial production.
- The Operations Lead is accountable for the effective and efficient running of all operations activities to a defined daily, weekly and monthly schedule as agreed with our customers. This requires a flexible, collaborative, multi-skilled teamwork environment.
- Accountable to deliver on production requirements
- Responsible for tactical and strategic planning and decision making for the Biologics IPT, to ensure supply of high quality product through tactical planning and execution of production schedules.
- Providing coaching and support to the Biologics operations colleagues, including the identification and development of key talent and skills within the team.
- Drive the team's performance so that every individual understands their individual contribution and how it impacts the site.
- Consistently deliver on key performance metrics, e.g. schedule adherence, EHS and Quality Compliance, and budget performance.
- Foster collaboration with other functional support and operations areas.
- Proven financial stewardship for budget development and control.
- Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools within the IPT
- Proven track record of delivering high performance through development and coaching of a team.
- Provide Operations leadership on strategic new project and process tech transfer activities
- Demonstrated ability in holding team members accountable for results and managing performance.
- Demonstrated ability to fully realize improvement initiatives.
- Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
- Ensure the highest Quality, Compliance and Safety standards.
- Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
- BSc Degree in Science or engineering discipline
- 5 + years' experience in Operations leadership role within a Biologics Operations
- Demonstrated knowledge in more than one pharmaceutical and/or Biotechnology manufacturing operation (e.g. manufacturing, technology, engineering, quality.)
- Evidence of Continuous Professional Development
- Demonstrated capability to deliver results in compliant cost effective manner
- Demonstrated experience with Industrial Relations.
- Demonstrated leadership, including change management skills with a continuous improvement focus
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