An amazing opportunity has arisen for a Drug Substance Process Operations Manager. The successful candidate will be accountable for end-to end production supporting Solution Supply/Weigh&Dispense, Batch and Continuous Manufacturing. This requires the management of a stable process supported by a flexible, collaborate, multi-skilled teamwork environment.
The Biologics Innovation facility at Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility, will provide Biologics manufacturing for Clinical Supply, Registration & Commercial Launch. Dunboyne serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them.
Bring energy, knowledge, innovation to carry out the following:
- Inspire Diversity and Inclusion – building working effective working relationship within a cross-functional team across different 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
- Implement and oversee tier 0 and represent the area(s) at tier 1 and tier 2, 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.
- Act as first level support in the event of problems on the manufacturing floor
- Maintain area in GMP Compliance and maintain team training. Collaborate with other teams or departments to ensure cross-functional compliance.
- Oversee the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs.
- Embody Safe by Choice – know and 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.
What skills you will need:
- 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 analyzing complex situations and show practical problem-solving capabilities.
- 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 requirement
- Experience in quality management systems such as Veeva, SAP, PAS-X etc..
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
