Principal Scientist – Process Characterization

Location: Austin, TX
Department: Azzur Austin, LLC

Job Description

Azzur Group is seeking a dynamic and dedicated Principal Scientist – Process Characterization to fulfill the leadership role of the Process Characterization (PC) Unit as part of the Process Development team. This person will lead a growing team of talented scientists and work directly with counterparts within the the organization to deliver on an expanding globally harmonized PC business model. The PC laboratories will include state of the art instrumentation to support late-stage process characterization activities for biopharmaceutical programs for external sponsors. It is preferred to find a candidate with exposure to upstream, downstream, and analytical biopharmaceutical development and process characterization.

Essential Functions:

  • Oversee the operation of the Process Characterization (PC) unit providing line management and leadership to the PC unit team.
  • Accountable for the technical delivery of multiple PC programs by the application of scientific knowledge, project management and leadership skills.
  • Strong working knowledge of upstream, downstream and analytical areas
  • Scale Down Model (SDM) establishment (USP and DSP)
  • Development of Process characterization experimental work plans to identify CPPs in collaboration with the process design team, prospective clients and relevant site of manufacture
  • Delivery/ Review of Process characterization protocols that enable robust execution of Process Characterization work flows
  • Delivery of Process characterization reports, providing sufficient depth of understanding to enable key process validation decisions to be made.
  • Track the performance of the PC unit through review of relevant metrics indicating the performance of the unit in the following key areas: safety, quality, staff engagement, equipment utilization, right first time and profitability.
  • Regularly communicate the performance of the unit. Identify and implement efficiency savings to improve the performance of the unit e.g., Review and implement systems to drive efficient data flows.
  • Host client meetings and form part of the Client engagement process to win new business

Required Skills & Abilities:

  • Directs the work of PC scientists alongside the PC functional leads and ensures that project milestones are met on time and to budget.
  • Providing expert scientific counsel to clients and project teams on the most appropriate way to execute Process characterization work plans to support process validation at the proposal and scope development stages.
  • Maintain strong communication with other technical leads from process design, TPL group, and FDB sister site and clients.
  • Representing FDB externally at meetings and conferences including presentation Process validation approaches which enhance the reputation of the business.
  • Resolve conflicts and remove obstacles that stand in the way of accomplishing project goals and objectives.
  • Support the Business using expert knowledge during Audits.
  • Ensure safe systems of work are set in place to protect staff
  • Provide opportunities to coach and develop staff working within the group
  • Foster a quality culture where the highest standards of quality and data integrity are valued.
  • Operate the unit in line with Azzur Group and client's core values, encourage, and support all employees within the unit to do likewise.
  • Develop a continuous improvement culture within the PC unit where team members are encouraged and supported to drive improvements.
  • Through implementation of appropriate systems and development of key measures, monitor and report on operation of PC Unit.
  • Work closely with the PC Project Manager in project planning and responses to changes in priorities.
  • Excellent communication and influencing skills are required to support clients at the most critical stage of their drug candidate journey.
  • Must work well with multiple stakeholders across multiple sites and be sensitive to their respective requirements and will be expected to be a member of the TPL group.
  • As a senior member of the PC unit team the candidate should be prepared to coach / mentor and provide council and guidance to other team members.
  • Forward thinking and enterprising the candidate should help the PC unit maintain a competitive edge by remaining open to new ways of working to improve the efficiency of the unit including the use of high throughput technologies and software.

Working Conditions & Physical Requirements:

  • The candidate will be operating in a regulated environment and must maintain in-depth awareness of the regulatory background and expectations, industry best practices.
  • A quality culture is critical and as a senior member of the team, the candidate should uphold the highest level of quality and data integrity standards.

Minimum Qualifications:

  • A minimum MS / BS and 12+ years’ experience or PhD and 10+ years’ experience.
  • At least 5+ years of management or supervisory experience.
  • Demonstrated group leadership in analytical biopharmaceutical development is essential, along with a strong understanding of protein upstream and downstream development and analytics. It is preferred that the candidate have strong customer-service, communication and leadership skills and have experience in client-based project management.

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers, and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States, we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To Delivery TM.


Apply Now

Life Science Moves FAST

Stay in the know by signing up for our newsletter. We’ll share company successes, industry must-know information, and keep you updated on the latest events you don’t want to miss.