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Associate Director, Drug Substance Technical Steward – Global Technical Operations

Plats Gaithersburg, Maryland, USA Jobb-id R-089279 Datum inlagd 08/26/2020

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.

In Biologics Global Technical Operations (GTO), we work closely across AstraZeneca’s manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline.

As an Associate Director for Drug Substance (DS) Technical Steward, you will be assigned a portfolio of late-stage or commercial products, with overall responsibility of providing hands-on technical leadership during the technology transfer phase, process qualification, and regulatory submissions. In this capacity, you will work closely with Biopharmaceutical Process Development (BPD), manufacturing sites (internal or external), other GTO functions, and Quality organizations.

This role will report directly to the Senior Director, Drug Substance Network Lead and serve as the Operations DS representative on the Product CMC teams, providing technical expertise for ongoing commercial manufacturing and manages post-approval changes. While this position does not have direct reports, it will be leading cross-functional teams, connecting across internal organizations and CMOs, and serving as a mentor to others as required.

To succeed in this role, you will need to be self-motivated, innovative, have strong technical and communication skills, and a deep understanding of biologics manufacturing, quality, and process development.

Main Responsibilities:

Drug Substance Technology Transfer

  • Lead technology transfer of commercial drug substance processes (upstream and downstream) into external manufacturing sites.
  • Author and approve process descriptions and facility fit assessments for multiple manufacturing sites. Develop predictive tools to map cell culture and purification processes into commercial facilities in the AstraZeneca network.
  • Review and approve tech transfer and manufacturing documentation such as risk assessments, gap analyses, batch records, standard operating procedures and sample plans.
  • Support preparation of regulatory submissions, oversight during inspections and audits, and respond to questions from regulatory bodies.

Commercial Manufacturing

  • Resolve production issues, deviations and negative trends by interfacing with relevant manufacturing site(s), Quality/Regulatory, Engineering, Validation, and Development to implement solutions.
  • Drive implementation of continuous improvements to support robust and reliable, compliant commercial manufacturing processes leveraging risk-based processes.

Drug Substance Manufacturing Technology

  • Stay abreast of the latest technologies used in Biologics with a view commercial feasibility for AstraZeneca commercial product portfolio and pipeline.
  • Integrate new technology into existing GMP manufacturing environments in relevant sites.

Minimum Requirements:

Essential:

  • Degree in an engineering or scientific discipline with experience in biopharmaceutical manufacturing/development/process engineering
  • B.S with 14+ years of proven experience
  • Extensive technical knowledge of commercial biologics manufacturing with strong focus on mammalian cell culture processes (large scale bioreactors, media development and harvest operations).
  • Working knowledge of downstream unit operations (chromatography, virus filtration, TFF etc).
  • Ability to work on multiple projects and meet deadlines as needed; Emphasis on results-oriented, strong planning and execution skills

Desired:

  • M.S. with 12+ years of demonstrated ability
  • PhD with 10+ year of demonstrated ability
  • Prior experience with late phase DS process development and regulatory authority submissions/ global technology transfers/commercial Manufacturing Science and Technology is a plus.

Travel:

This role supports contract manufacturing for AZ and may have up to 25% travel throughout the US, Europe and Asia-Pacific countries.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.



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.

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