Overview
Job Description
An amazing opportunity has arisen for a Drug Substance Process Operations Shift Manager, at our Biologics Innovation in Dunboyne, Co. Meath. The successful candidate will be accountable for end-to end production supporting Solution Supply, Batch and Continuous Manufacturing. This requires the management of a stable process supported by a flexible, collaborative, multi-skilled teamwork environment.
Responsibilities
* Inspire Diversity and Inclusion – building effective working relationships within a cross-functional team across diverse cultures and backgrounds.
* Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own leadership and technical/functional skills.
* Ensuring appropriate level of preparedness of any escalations, fostering a culture of openness, collaboration, and attention to detail to achieve schedule/project task delivery.
* Recognizing that action is required and working to generate alternatives, generate options and choosing effective options, knowing when other stakeholders support is needed.
* Drive operational excellence to deliver all components of a stable process for PPQ, facility start-up and commercial supply.
* Maintain area in GMP Compliance and maintain team training. Collaborate with other teams or departments to ensure cross-functional compliance.
* Oversee the development and approval of GMP Documentation
* Follow the Safety, Health and Environment guidelines and work towards company safety and environment goals.
* Influences, partners, and collaborates with other colleagues within and outside their team to build trust, encourage two-way communication and strengthen relationships.
* Change management leadership demonstrating adaptability and openness to change, exploring the benefits, and collaborating with others to make it effective.
People Management
* You will be responsible for setting performance goals, conducting performance evaluations, and identifying training and development opportunities for your team.
* Provide your team with the tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma) to make them successful.
* Assessing workload, identifying gaps or imbalances, and reallocating resources or making hiring decisions to optimize staffing levels and ensure efficient operations.
* Foster a feedback culture within the team or organization, encouraging open and honest communication.
Your profile
* Bachelor’s degree in biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
* 6 years + experience in Biotech industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate.
* Competent in analysing complex situations and show practical problem-solving capabilities.
* Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
* Ability to work independently and within a cross-functional team.
* Demonstrated experience in QRM, Investigations and Problem solving.
* Familiarity with contamination control and batch release requirements
* Experience in quality management systems and operating systems such as Veeva, SAP.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
#J-18808-Ljbffr