At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
As a Process Scientist in the Sweden BioManufacturing Center (SBC), you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. AstraZeneca SBC is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Main Duties and Responsibilities
This position is responsible for scientific aspects of commercial operations for new product introductions, tech transfers of late stage clinical and on-market drug products into the SBC facility.
The Process Scientist is responsible for working with commercial operations to support existing commercial products and working with R&D to ensure that drug product processes are scalable and can be efficiently manufactured in commercial operations.
The Process Scientist will lead technology transfer teams to facilitate transfers of late stage processes to the SBC site. It is the responsibility of the Process Scientist to ensure that the process is commercially viable as demonstrated by successful process validation / process performance qualification study, regulatory approval, and ultimately a successful product launch.
The Process Scientist position requires interactions with multidisciplinary and multisite groups, which may include product specific Global Supply Teams, Global Tech Operations, Global Engineering, other site’s MS&T teams plus all local site functions, sending site technology transfer teams, external vendors, and other strategic suppliers.
Process Science responsibilities
- Provide relevant scientific advice and input on final bulk formulation, single use fluid pathway technology, primary containers, isolator technology, filing and lyophilization process, filled drug product visual inspection and the final drug product manufacturing process including device assembly and secondary packaging components specifications and acceptance criteria establishment
- Provide scientific expertise and technical rigor in experimental design and data analysis across projects
- Contribute to development, operation and continuous improvement of the SBC DP and FDP commercial manufacturing facility capabilities
- Provide a consistent approach across projects by developing risk assessment tools, study protocols and report templates
- Mentor and teach process science concepts to staff members
- Carry out ongoing academic and regulatory literature review, maintain a cutting edge technical knowledge, and communicate findings to team
- Perform risk analyses, write study protocols and perform site engineering studies to characterize processes
- Perform, analyse and interpret data from a range of protein and peptide characterisation assays (e.g. HPLC, UPLC, HIAC, MFI, cIEF)
- Design process steps, establish associated operational design space and control strategy
- Support commercial, engineering and clinical fills at internal and external sites, provide support to help close manufacturing non-conformances
- Author or contribute to regulatory documents supporting clinical and commercial filings
- Review and approve batch records, validation protocols, and other GMP documents
- Provide on-site support of engineering runs and GMP batches at internal and external manufacturing
- Works with Engineering, Supplier Quality, and other functions to ensure that appropriate equipment is qualified and available for manufacturing and device assembly if appropriate
- Facilitates alignment of Development and Operations technical decisions necessary through completion of Process Validation to ensure commercial viability of the manufacturing process
- Reviews and approves site and supplier changes to materials/specifications
- Helps to develop long term drug product manufacturing strategies in conjunction with Operations, BiologicProcess Development, and others
- Provides support for regulatory submission documentation as required
Technology Transfer responsibilities
- Lead the technical transfer of commercial DP and FDP manufacturing processes to the SBC site (including technical support for clinical technology transfer as required)
- Organize the SBC site receiving unit team including formulation, process, device, analytical, packaging, operations, supply chain, project management and QA.
- Manage timelines and activities internally, communicate goals and track deliverables at the receiving site
- Communicates pertinent information to appropriate representatives to ensure successful product transfer and commercialization
- Experience in a biotech/pharmaceutical company
- The candidate will have direct experience with biologics drug product manufacturing, technical support of drug product manufacturing or drug product development experience with some oversight of manufacturing
- Experience commercializing a biological combination product is a plus
- The candidate will have a broad understanding of Operations including Manufacturing Operations, Supply Chain, Quality Assurance, and Quality Control
- Excellent communication skills with the ability to work effectively in cross functional teams and effectively influence team members
- Ability to communicate effectively across levels, across functions, and with senior managers
- Ability to work in a complex, dynamic, global environment and willingness to travel when necessary
- Excellent communication skills with the ability to work effectively in cross functional teams and effectively influence team members. Establish effective relationships with stakeholders
- Innovative problem-solving skills
- Strong technical writer
- Statistical analysis experience a plus
- PhD or Advanced degree in Engineering or life sciences preferred, in addition to extensive relevant experience
If you are interested, apply now!
For more information about the position please contact Martin Hunter, Manufacturing Science & Technology Lead at email@example.com
Interviews will be held ongoing during the application period.
Welcome with your application no later than August 19, 2018.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.