Associate Director-Biotech Operations
6 months ago
We’re looking for people who are determined to make life better for people around the world.
Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup GMP manufacturing operations.
Main Purpose and Objectives of Position:
The Associate Director Biotech Operations provides leadership and direction to the cross functional process team and to the manufacturing operations team to ensure that they meet their short to medium term goals including day to day technical leadership activities. The leader also ensures that the team’s activities are appropriately resourced and integrated with the site’s longer term objectives.
Responsibilities:
The following are the main routine objectives for the Associate Director Biotech Operations role:
Promotion of a strong Safety and Quality culture.
Participation in the creation, approval and execution of the production plan for the assigned area.
Maintain a safe working environment and conduct production activities in a manner that protects safety, environment and quality.
Ensure consistency of operations across shifts through active engagement on the production floor.
Ensure all necessary systems, procedures, equipment and facilities are installed, qualified, validated, maintained to appropriate standards.
Support New Product Introductions to the site as required.
Support and provide leadership to the area through site inspections.
Own the implementation of the change and improvement agenda for the assigned area
Setting objectives for the cross-functional Process Team, and owning and reviewing their scorecard with management.
Manage events as required, ensuring appropriate communication within the team and with external teams. Provide input and approve investigations.
Build a team, creating clear common purpose and promoting good team spirit.
Ensure that team members are appropriately trained, and that operating procedures and training material are available and current.
Manage people training, qualification and performance. Set job expectations and goals for individuals linked to team/site goals. Develop people.
Communicate appropriately with team members regarding site objectives and team business.
Ensure the team is adequately resourced to meet the business objectives.
Manage collaborations, both formal and informal, between the team and functional support groups such as maintenance, engineering, analytical, financial, purchasing and technical support.
Be an engaged member of the cross functional management team (Flow team) and be an active member of Site Management
Specifically during the startup phase of the Limerick site (2023 to 2025) leadership will be expected to be a collaborative, inclusive, energetic leader and support the broader Limerick team to:
Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of excellence
Develop and implement the systems and processed needed to run the site, leveraging existing Lilly knowledge and practices where necessary, but also incorporating external experiences and learning.
Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach
Support the project team as they deliver the facility to the site team, by providing feedback and support on decisions & strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
Basic Qualifications:
Previous GMP Manufacturing experience and/or experience working with an operations team.
Previous supervision/leadership of a cross functional team or project.
Bachelor of Science, Engineering or equivalent experience.
Additional Skills:
Preferred > 8 years industrial experience in a cGMP environment.
Strong interpersonal communication skills.
Ability to work independently, self-sufficiently and pro-actively in the performance of work duties.
Ability to resolve conflict and promote good decision making among team members.
Solid understanding of the importance of and basic requirements of Regulatory agencies such as the FDA, HPRA, HSA and EPA.
Business Knowledge : High performance in delivery of their work. Looks at better, simpler ways , takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation and organisational skills.
Learning agility and Curiosity : High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop and implement solutions.
Positive Influence : Demonstrated ability to address issues as they arise and take action. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.
Relationship Builder : Demonstrated ability to establish and maintain key relationships across all levels in the organisation.
Ability to lead people : Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
Communication : Demonstrated strong communication skills, written and oral in 1:1 and group situations.
Decision Making : Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly
-
Associate Director
6 months ago
Limerick, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include Next Generation manufacturing technologies and...
-
Associate Manager Biotech Production
1 month ago
Limerick, Ireland Regeneron Ireland DAC Full timeWithin this role will manage the day-based support requirements of the manufacturing operations team while providing direction, troubleshooting and guidance while maintaining safety compliance and audit readiness and ensuring objectives are delivered to a high standard and on time. As an Associate Manager Biotech Production (Downstream Operations) a typical...
-
IT Business Operations Analyst
4 weeks ago
Limerick, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
IT Business Operations Analyst
4 weeks ago
Limerick, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Biotech Production Training Specialist
4 weeks ago
Limerick, Ireland Regeneron Ireland DAC Full timeAs a Biotech Production Training Specialist, a typical day might include, but is not limited to, the following: Assisting manager in creating training scenarios when necessary Delivering Biotech Production Specialist training and provides individual assessment to the performance of each Biotech Production Specialist's aptitudes prior to deployment into...
-
Facilities Project Engineer
2 months ago
Limerick, Ireland PSC Biotech Ltd Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Facilities Project Engineer
2 months ago
Limerick, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Data Analyst
2 weeks ago
Limerick, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Limerick, Ireland Regeneron Ireland DAC Full timeThe Associate Director/Director of Technical Operations is responsible for leading the Biopharmaceutical Process Equipment Engineering & Maintenance teams with management responsibilities of direct employees, contractors and specialist vendors involved in supporting GMP manufacturing operations and maintenance. This individual will provide technical...
-
IT Compliance Analyst
2 months ago
Limerick, Ireland PSC Biotech Ltd Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Construction Supervisor
2 months ago
Limerick, Ireland PSC Biotech Ltd Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Data Analyst
2 weeks ago
Limerick, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Technical Writer
2 weeks ago
Limerick, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Technical Writer
2 weeks ago
Limerick, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
IT Compliance Analyst
2 months ago
Limerick, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Cleaning Validation Executor
2 weeks ago
Limerick, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Construction Supervisor
2 months ago
Limerick, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Technical Writer
2 weeks ago
Limerick, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Cleaning Validation Executor
2 weeks ago
Limerick, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Technical Writer
2 weeks ago
Limerick, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
