Consultant, Process Development

Organization
Aeras
Job Location
Rockville, MD
Job Description

Contract/Temp to Perm Opportunity 

The primary objective of the position is to rapidly establish and lead the Process Development group to design and scale up GMP manufacturing processes for vaccines and recombinant proteins to be used in human clinical trials. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 
• In conjunction with the leadership team, develop and drive the Aeras’ product development strategies for vaccine manufacturing 
• Hire, train, and manage a world-class process development team 
• Establish a state of the art process development laboratory to support company’s future cGMP manufacturing efforts 
• Develop product manufacturing plans to meet corporate objectives and priorities 
• Ensure the timely development of upstream, downstream processes, and analytical methods for multiple products 
• Support the technology transfers to GMP Manufacturing within Technical Operations 
• Identify and manage strategic outsourcing opportunities to accelerate product development in cost efficient ways 
• Effective communication of results to senior management, Board and partners 
• Build/facilitate external client relationships 

ROLE FLEXIBILITY: 

It is understood that the incumbent will be expected to display some flexibility and, when pertinent, be able to work in other priority areas within the organization. Such transient changes in duties will not represent a change in status and will not place an onerous burden on the incumbent. 

SUPERVISORY RESPONSIBILITIES: 

Direct reports include scientists in Fermentation, Purification, and Formulation.

Requirements: 

• Ph.D. in biochemical engineering or Life Sciences and more than 10 years of biopharmaceutical industry experience in process development of vaccines and recombinant proteins 

• Proven thought leader in process development as demonstrated by accomplishments, publications, presentations, or products in development 

• Extensive understanding and practical knowledge of all aspects of process development, including: 

* Cell line development 
* Cell culture/fermentation 
* Protein purification and characterization 
* Formulation 
* Fill / Finish 
* Analytical development 
* Process technology transfer 

• Good understanding of vaccine development processes, including bacterial and cell culture operations 

• Experience communicating directly with regulatory agencies and preparation and review of CMC sections in regulatory filings 

• Demonstrated leadership, commitment to achieving goals, ability to solve problems, excellent oral and written communications and interpersonal skills 

• Experience validating and manufacturing licensed human vaccines a plus. 

PRINCIPALS ONLY

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