Manufacturing Associate I/II - BPD
The Manufacturing Sciences team, based in Gaithersburg, Maryland, is a fully integrated process scale-up and biomanufacturing function. At our Pilot Plant Facility, our dynamic clinical manufacturing team performs bioprocessing operations for novel molecules to support the development of new medicines. We produce pre-clinical and early through late stage clinical drug products that advance AstraZeneca’s biologics pipeline.
Description of Position:
As a member of the Manufacturing Transfer & Integration team, you will be supporting the department’s goals by:
- Interpreting, adapting and translating technical drug development information into coherent procedures/instructions.
- Leading investigations, driving corrective/preventive actions.
- Providing technical compliance support, expertise, and training as required.
- Preparing for new production campaigns by mapping out material demand, logistics, and operational strategies.
- - MA I: Bachelors degree in a scientific discipline OR 2 years related GMP experience is preferred
- - MA II: Bachelors degree in a scientific discipline and 4+ years related experience OR Masters degree in a scientific discipline and 1 years related experience OR 2+ years related GMP experience
Principal Duties MA I:
- - Authors less complex Master Production Records (MPR’s), Standard Operating Procedures (SOP’s), and Solution Preparation Records (SPR’s) as needed to accurately reflect manufacturing process.
- - Initiates change review and approval for documents through document control system.
- - Supports minor non-conformance investigations, CAPA identification & on time closure of quality records in Trackwise.
- - Assists with simple change control requests and implementation of new equipment.
- - Maintains master batch production templates, technical references and source documents.
- - Supports operational excellence initiatives.
- - Observes development and GMP production activities to understand operating process and procedures.
- - Assist in preparation of professional technical and GMP oriented training materials.
- - Periodically enter training data into the training database and perform spot audits of the documentation.
Principal Duties MA II:
- - Authors increasingly more complex Master Production Records (MPRs), Standard Operating Procedures (SOPs), and Solution Preparation Records (SPRs) as needed to accurately reflect manufacturing process.
- - Creates Bill of Materials (BOMs) for platform and resupply tech transfers.
- - Authors Master Specification for raw materials.
- - Maintains current master batch production templates, technical reference and source documents, ensuring revisions are incorporated in a timely fashion.
- - Leads investigations for minor non-conformances.
- - Authors simple change control requests.
- - Assists management and subject matter experts in design, development, and delivery of training initiatives for the Manufacturing Sciences Organization
- - Works collaboratively with Manufacturing/Tech Transfer/Quality and other Development functions on cross-functional teams
- - Identifies and executes process improvements.
- - Independently manages tasks and timelines associated with batch record writing and non-conformances.
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 authorisation and employment eligibility verification requirements.