Associate Director, Drug Product Technology

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 peoplexceptional skills with those of people from all over the globe. As an Associate Director, Drug Product Technology in Gaithersburg, MD, youplay a pivotal role in channeling our scientific capabilities to make a positive impact on changing patientsves. Operations at AstraZeneca 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 technical aspects of commercial operations for marketed drug products such as product revalidation, transfer or improvements of commercial products and new product introduction. The Associate Director, Drug Product Technology (AD) 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 AD also works with technology transfer teams to facilitate transfers of late stage processes to drug product external manufacturing vendors (CMO). It is the responsibility of the AD to ensure that the process is commercially viable as demonstrated by successful process performance qualification study, BLA approval, and ultimately a successful product launch.

The Associate Director position requires interactions with multidisciplinary and multisite groups, which may include CMOs, technology transfer teams, external vendors, and other strategic suppliers. ADs are responsible for communicating status to the CMC teams through representatives. Once the product is licensed by the regulatory authorities, the responsibility for commercial manufacturing transitions to another organization within AstraZeneca.

• Participates in drug product technology transfer teams when AZ Biologics/Medimmune is working with CMOs.
• 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.
• Assists with device manufacturers for commercial product.
• May participate in vendor visits of potential drug product and device companies.
• Communicates pertinent information to appropriate representatives to ensure successful product transfer and commercialization.
• Helps to develop long term drug product manufacturing strategies in conjunction with Operations, BioProcess Development, and others.
• Reviews and approves site and supplier changes to materials/specifications
• Responsible for technology transfer of device technology as receiving group for biologics operations;
• Provides commercial operations support during lifecycle for process improvement, revalidation of transfers.
• Develops and transfers robust processes to internal or external manufacturing sites
• Provides review and oversite of capital equipment spends associated with commercial scale up purchases. Influence decisions at sites in respect to investments and asset utilisation
• Provides support for regulatory submission documentation as required

Essential Requirements

• Greater than 10 yearsperience in a biotech/pharmaceutical company.
• The candidate will have direct experience (greater than 5 years) 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
• Experience support functional testing of devices and/or device complaints evaluation is desired.
• The candidate will have a broad based 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

Desirable Requirements

• PhD or Advanced degree in Engineering or life sciences preferred, in addition to extensive relevant experience

Typical Experience / Educational Background Preferred:

20+ years with BS Degree in Engineering or life sciences

17+ years with MS Degree in Engineering or life sciences

10+ years with Ph.D. Degree in Engineering or life sciences

Next Steps ply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience 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 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.

Date Posted 26-Jul-2017

Closing Date