Senior Specialist Materials

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion AstraZeneca Rare Disease, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

The Technical Services team are process subject matter experts and provide technical support to projects and a variety of complex issues that arise in manufacturing. The Materials Senior Specialist will work alongside Quality, Technical SMEs, Supply Chain, Analytical Development teams (internal and external) and QC to execute tasks associated with introduction and qualification of new raw materials for existing and new products including associated deviations or changes to approved processes. They will gather and analyze data, draw conclusions, and make recommendations to the broader technical services team. The Material Senior Specialist will also support major projects with report writing, presenting process data, managing project schedules and communicating progress to the wider team.

The person should have experience in cell culture and purification unit operations, Risk Assessment (using QRM tools), and have experience in managing new material introduction within a GMP environment.

You will be responsible for:

• Serve as subject matter expert (SME) on new material introduction (NMI) for the BDS facility, including single-use systems and raw materials specification generation, extractable and leachable (BPOG) and chemical compatibility risk assessment.
• Responsible for technical leadership and managing the introduction of new / second sourcing of raw materials / consumables to the ADMF facility including generation of material lists, Bill of Materials, valiation studies and technical risk assessments.
• Manage supplier change notifications within the team and lead key material process changes using a change control system.
• Partner and support Technical Services teams in daily activities on Upstream and Downstream Materials work fronts.
• Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs, Global strategic teams, and internal partners (Process Development, Manufacturing, and Quality).
• Participate in investigation teams, and support raw material change requests for vendors.
• Work closely with Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials in line with technology transfer / commercial schedules.
• Author and review technical material evaluations (risk assessments) to support new product transfers to site, protocols, reports and strategy documents.
• May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing.
• Serve as SME for NMI during regulatory/audit inspections.

You will need to have:

• BSc or MSc in in Biotechnology, Biological Sciences, Biochemistry, Bioengineering or a similar scientific field.
• Minimum 4+ years’ experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization.
• Technical and operational knowledge of upstream and downstream pharmaceutical processes, quality systems and regulatory requirements across multiple health authorities.
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
• Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization and in local group settings.
• Ability to present and defend technical and scientific approaches in both written and verbal form.
• Ability to drive for results independently and adapt to rapidly changing priorities.
• Detail orientated.
• Strong background in technical writing with experience in quality risk management practices and documentation.

We would prefer for you to have:

• M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
• Experience managing new material introduction within a GMP environment.

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.