Director/VP Process Development - Rockville - job 635892

NXTThing RPO, LLC

Date: 02/23/2021

City: Rockville, Maryland

Employment type: Full-time

Company Description




Our Mission


Aurinia exists to make a difference. From the earliest days of the company, we’ve seen the potential in applying a creative, thoughtful and responsible approach to developing and commercializing therapies with a goal of changing the course for patients in disease areas that have been historically challenging to address. We Care, for our patients and our employees.


We are currently commercializing a treatment of lupus nephritis (LN) in the United States and preparing for potential commercialization of this compound in the EU, UK, Russia and Japan with Otsuka Pharmaceutical. We are also looking to leverage our internal capabilities to advance additional innovative therapies which have the potential to change the lives of people with rare autoimmune and inflammatory diseases.




Job Description




Aurinia is seeking a professional and motivated individual to take ownership of the vision, design and build out of our process development function. As the leader of the function, this position represents a single point of CMC accountability for advancing Aurinia’s pipeline. The candidate should have experience working in a fast-paced, high-growth environment and should be able to contribute immediately, leveraging past leadership experience with a desire to build from the ground up.



Primary Responsibilities



  • Sets the vision and direction and develops strategic plans for process development at Aurinia.

  • Oversees development, implementation and maintenance of process methods and equipment for the production of process formulas, technologies, and products to ensure cost effectiveness and improved product quality.

  • Ensures development processes comply with regulatory requirements to minimize risk to the organization.

  • Addresses the analysis and evaluation of process development procedures and practices to ensure compliance with regulatory, legal and good manufacturing procedures to attain corporate goals.

  • Ensures the organization is adequately staffed with the right team to build and bring on talent when needed.



 




Qualifications




  • PhD. plus 15+ years of experience in the pharmaceutical and/or biotechnology industry with 5+ years demonstrated leadership in process development, preferably within a high growth environment.

  • Experience developing, implementing and executing strategic plans and objectives; ability to create strategies that show a clear connection between vision and action.

  • Experience participating in the development of corporate methods, techniques and evaluation criteria for projects, programs, and people.

  • Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results

  • Demonstrated communication, problem-solving, and negotiation/decision-making skills; an executive presence

  • Ability to think outside of the box and challenge the status quo

  • Desire to work in a fast-paced, innovative environment and develop a high performance team

  • Ability to comfortably manage the uncertainty of change

  • Natural collaborator who enjoys working on cross-functional teams and is an influencer

  • Ability to consistently exhibit Aurinia’s We Care values of creating opportunity, acting responsibly, relentlessly persevering and executing with integrity



Additional Information



All your information will be kept confidential according to EEO guidelines.





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