Specialist Technical Services Materials

Job Title: Specialist Technical Services Materials

Introduction to role

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 Material Specialist will work alongside Quality, Technical SMEs, Supply Chain, Analytical Development teams (internal and external) and QC to execute tasks associated with the 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 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.

Accountabilities

• 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 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.
• 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.
• Review and support technical material evaluations (risk assessments) to support new product transfers to site, protocols, reports and strategy documents.
• Serve as SME for NMI during regulatory/audit inspections.

Essential Skills/Experience

• BSc or MSc in Biotechnology, Biological Sciences, Biochemistry, Bioengineering or a similar scientific discipline.
• Minimum 3+ 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.
• Technical writing competency.

Desirable Skills/Experience

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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Explore rare opportunities at Alexion, AstraZeneca's Rare Disease division. We are at the forefront of biomedical science, pushing the boundaries of science to translate complex biology into transformative medicines. With our resources and global reach, we are uniquely positioned to shape the future of rare disease treatment, helping people live their best lives.

Ready to make a difference? Apply now!

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.