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Scientist II - Operations

Plats Frederick, Maryland, USA Jobb-id R-064463 Datum inlagd 10/28/2019

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost 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 aScientist II in Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Main Responsibilities

Scope:

  • Responsible for maintaining technical expertise on the entire section of downstream bioprocessing manufacturing. Experience in clinical/commercial bioprocessing is essential to this position.
  • Demonstrates specific downstream purification unit operation knowledge in support of clinical/commercial bioprocessing of large molecule biologics (chromatography, normal/tangential flow filtration, virus filtration, etc.).
  • Demonstrates a strong knowledge of cGMP compliance, site and regulatory agency requirements and procedures.
  • Supports bio-process technology transfer, process validation and the preparation/review of CMC documentation for regulatory filings.
  • Plans, designs, and executes multiple simultaneous projects that are complex and technically demanding within the area of downstream purification.
  • Initiates, implements, plans, directs, and executes investigations to assist in the resolution of manufacturing deviations, understanding downstream process trends, and/or improve overall process performance. 
  • Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
  • Utilizes forward-looking perspective to contribute to “go/no go” decisions for manufacturing-related issues.
  • Responsible for balancing day-to-day technical support for manufacturing and longer-term projects and investigations. Typically conducts more than one significant project at a time.  
  • Works under general supervision of a higher-level scientist/manager or department head. Work is performed without appreciable direction. 
  • Makes detailed observations, analyzes data, and interprets results. Likewise, effectively presents results at internal meetings and external scientific meetings. 
  • Responsible for meeting project goals within time and budget constraints. 
  • May make recommendations on outside technologies for company to pursue.
  • May directly supervise lower-level scientists and associates.
  • Maintains high level of expertise through review of current scientific literature, submissions to scientific journals, and attendance and participation at conferences focused on the research and development efforts of the company.
  • Develops solutions to complex problems requiring ingenuity and creativity. 
  • Applies knowledge of technical theories and principles on a broad base where analysis of situations or data requires an in-depth evaluation of various factors.
  • Has latitude in determining technical objectives of assignment. 
  • Work is monitored for technical judgment and achievement.
  • Decisions or recommendations consistently result in achieving one or more key project objectives. 
  • Internal recognition as an emerging expert by the Medical and technical community through objective criteria such as publications, patents, internal presentations, and critical contributions to drug development. 
  • Has demonstrated leadership through project team participation, internal consulting and mentoring.
  • Interacts with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects (e.g., R&D, Quality Control/ Quality Assurance and GMP Manufacturing). 
  • Establishes contacts with outside centers of excellence in field of specialization and has contacts with customers and external suppliers. 
  • May have external alliances and activity in professional organizations.
  • Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.  Report potential issues of non-compliance.

Education:

  • BS Required, MS or PhD Preferred

Experience:

  • PhD 6 years, MS >8 years, BS >10 years

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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