BDS Manufacturing Support Training Specialist

Position Summary:

At the Alexion Bulk Drug Substance (BDS) facility in College Park, we have constructed a new state of the art bio-manufacturing facility.  We have also established a high performing team committed to creating a manufacturing culture of excellence in everything we do. We are committed to on time delivery of the highest quality product to our patients.

The BDS Training Team, within the Manufacturing Support group, provides training support to Site Operations - BDS Manufacturing, Packaging and Warehouse. The Training Specialist will provide key timely front-line training support to the BDS, Packaging and Warehouse processes during all phases of commercial supply including.

The Training Specialist responsibilities include the ownership of the training flow within Site Operations while also providing a key interface between the Site Operations teams and the Learning and Innovation team, optimising existing training practices and developing future ones.

You will be responsible for:

• Providing training support for sustaining manufacturing and new product introductions including, but not limited to - initial training, sustaining training, technical training, practical training and implementation of improvement projects
• Ownership of the Site Operations New Hire Onboarding process, and to continuous improvement of the process
• Continuous Improvement and Optimisation of existing training processes
• Taking an active role in introducing new and emerging technologies to improve the training experience for stakeholders
• Continuous monitoring of overdue and coming due training, and collation of routine metrics
• Attending and/or chairing Tiered meetings as required
• Performing technical writing and related editing functions to prepare training documents to support Site Operations
• Providing training to stakeholders on documents generated
• Working independently and/or within a team to accomplish job objectives
• Establishing and following priorities in assigned workload to meet department and Company objectives
• Establishing and maintaining effective working relationships with partners at College Park
• Leading and contributing to best practice sharing with manufacturing and technical colleagues at other Alexion facilities and across the industry
• Embedding the 3E (Education, Exposure, Experience) Framework of Learning in Site Operations and collaborating with other departments on same
• Supporting the Technical Operations MES team in developing and rolling out electronic batch records, electronic logbooks and other MES related projects
• Supporting Regulatory audits and inspections in a direct or indirect capacity
• Supporting wider business objectives in relation to Corporate and Social Responsibilities

You will need to have:

• Minimum of 2+ years’ experience working in a GMP environment such as Manufacturing Operations, Manufacturing Support or Equipment Engineering in a biopharmaceutical company or closely aligned industry preferred
• Experience in delivering technical training in a GMP environment
• Good knowledge of a biological manufacturing processes
• Well-developed analytical, numerical and digital literacy and the ability to combine hands-on activities with theoretical knowledge and expertise
• Strong Presenting and Training Skills
• Strong Technical writing skills
• Excellent communications and decision-making skills
• Confirmed ability to work well as part of a cross functional team & on own with minimum supervision
• Self-starter with strong communication, problem-solving and presentation skills
• Work collaboratively in a matrix environment

We would prefer you to have:

• BSc or MSc in Chemical Engineering, Bioscience, or Biotechnology.
• Experience in areas such as media prep, buffer prep, sterile filtration, upstream and downstream unit operations preferred (or other bioprocessing operations such as sterile fill finish)
• Experience in authoring GMP documentation, investigating complex manufacturing investigations, CAPA’s and Change Controls an advantage
• Green Belt in Lean six sigma an advantage

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.