Manufacturing Operations Shift Lead (API)

Job Title

Manufacturing Operations Shift Lead (API)

Requisition

JR000015990 Manufacturing Operations Shift Lead (API) (Open)

Location

College Park, Dublin - IRL006

Additional Locations

Job Description Summary

The Manufacturing Operations Lead is responsible for providing support and leadership to the
Manufacturing Operations Shift Team in the College Park Manufacturing Facility (CPMF) to
manufacture to the required safety, quality, and schedule and cost requirements to meet the
business needs.
You will work in partnership with Warehouse, Quality, Engineering and EHS to meet the CPMF
objectives. The role will include but not be limited to executing manufacturing activities,
building upon and improving existing process design to optimise process, facility and
equipment use while conforming to SOPs and cGMP requirements.

Job Description

Roles and Responsibilities:

-Ensure timely completion of plant operations, safe operations, attention to detail, and good

documentation skills. Directly oversees and participates in daily cGMP operations in a cGMP

environment.

• Ensure safety standards and policies are maintained and enforced. Be a role model these

expected behaviours

• Coordinate the workload of the shift team in order to meet schedules and timelines.

• Assist in the development of performance goals and objectives for team.

• Mentor and coach team in order to ensure full performance potential.

• Act as interface between management team and functional team.

• Participates in and attends cross-functional (multidiscipline) meetings when required.

• Resolve issues within area of control to ensure smooth running of manufacturing area

• Write deviation notifications when required by cGMP and/or SOP. Coordinate investigations

and corrective action follow-up to ensure closure.

• Reviews and approves area procedures, including SOP’s, master batch documentation,

change controls, and validation protocols/reports.

• Leads project-related working groups (cross-functional) in order to troubleshoot any issues

and to generate policies, etc.

• Supports inventory functions occurring in day to day business operations between

manufacturing and material management

• Work with the planning and warehouse function to coordinates the timely receipt and/or

release of materials to meet production needs.

• Network with all Area Leads and track area progress on key issues.

-Acts as designee / point of contact for Operations Manager when required.

Acts as senior person on site during out of normal hours activity

Minimum Requirements

Education / Experience / Skills:

• Requires BS/BA in Life Sciences or related field with 5+ years of relevant cGMP manufacturing experience.

• People management skills with experience of leading a team in a cGMP manufacturing environment

• Experience working in a Grade C / D environment

• Experience in Non-conformance initiation and investigation

• Ability to work in a team based environment

• Ability to manage a wide range of specific tasks

• Excellent organizational and coordination skills

• Experience with SAP ERP system an advantage

• Good interpersonal and communication skills, verbal and written.

• Thorough, diligent, good attention to detail

• Collaborator with strong levels of engagement with individuals and team

• An ability to work independently and as a member of a team in a complex, fast-paced and goal

driven environment.

• High level of delivery and work completion

• Strong decision-making capability.

• Demonstrated ability to lead change

• Working knowledge of six sigma and Lean Tools

• Ability to build a culture of positive engagement.

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova—keen to solve, keen to serve. Learn more atwww.keenova.com.