Director, FCC Development (Cell Culture / Vaccine)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Oct 13, 2021
Ref
R-150149
Required Education
Doctorate/PHD/MD
Position Type
Contract

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Summary:

The Director FCC Development is accountable for a team of scientists and engineers responsible for drug substance process development including cell culture, purification and virology.  The scope includes improving the existing process and developing a next generation process.  The Director FCC Development will also be a key contributor to define and drive process development strategy, oversee functional laboratory activities, and build and develop a high performing technical team.

Major Accountabilities:

Process and Product Development:

  • Develops and implements the process development strategy as the key accountable leader and technical expert for the cell culture-based influenza vaccine antigen process (FCC) with a focus on improving productivity, reliability and cost control
  • Leads own multifunction team and collaborates with partner functions (i.e. Research, Analytical Development, Drug Product Development, Manufacturing Science & Technology, Engineering, Manufacturing, Quality, Regulatory) to deliver on FCC process and product development strategy
  • Is the technical subject matter expert in cell culture, purification and virology accountable for leading
  • technical teams developing process improvements and/or entirely new bioprocesses to increase FCC yield and process capability
  • Directs and integrates development projects across disciplines (cell culture, purification, virology) to deliver program goals
  • Responsible for developing and demonstrating process improvements (i.e. yield, process capability) and accountable for collaborating with Operations (Manufacturing Science & Technology, Engineering, Manufacturing, Quality, Validation) to drive implementation of improvements in manufacturing
  • Author key technical documentation including product and process development plans, contract development and manufacturing proposals, quality target product profiles (QTPP), and technical transfer plans
  • Writes technical content for CMC sections of regulatory license documents (i.e. IND, BLA)
  • Proactively identifies innovation opportunities in cell culture, purification and virology to enhance bioprocess development projects
  • Identifies collaboration opportunities and provides technical oversight of product and process development activities sub-contracted to 3rd party development and manufacturing organizations
  • Represent TD on cross functional R&D and Operations leadership teams to provide program oversight, define strategy, and drive adherence to project plans

People Management:

  • Responsible for project and program level leadership within TD and in cross functional project teams
  • Drives culture of safety, ensures team adheres to requirements, and identifies and implements improvements
  • Develops multifunction team strategy and structure, recruits’ personnel, and builds capability to meet FCC process and product development program goals
  • Maintains a state of compliance for team and self through regular review of training and implementing training curricula improvements
  • Provides ongoing performance feedback, technical guidance and mentorship to FCC process development team

Operations/Quality Support:

  • Partners with Operations to transfer processes into manufacturing, and provides technical support during key tech transfer and validation (i.e. process performance qualification) activities
  • Utilizes knowledge and experience in bioprocess development to provide technical support for production of drug substance and drug product in GMP manufacturing
  • Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require TD support

Other:

  • Produce high quality technical presentations for internal audiences including senior leadership to update on project/program technical progress

Minimum Requirements:
  • Postgraduate degree (preferably PhD) and / or extensive experience in relevant industry or academic environment – scientific and people leadership
  • Minimum 8 years’ experience in biological drug discovery and / or development
  • Broad technical expertise in bioprocess design and development including cell culture and protein purification unit operations, ideally for production of vaccines
  • Expertise in process engineering scale up and scale down principles and techniques, including development of scale down models representative of manufacturing
  • Experience in media and cell line development ideal
  • Experience in virology concepts and virus cultivation ideal
  • Working knowledge of analytical methods used for characterization of bioprocesses
  • Uses broad and comprehensive technical, scientific or professional knowledge and experience to manage the outcomes and actions of a variety of complex projects
  • Extensive experience in exploratory data analysis and statistical techniques including design of experiments
  • Extensive experience writing content for technical documentation including product and process development reports, regulatory CMC license sections and presentations
  • Demonstrated competencies in ethics and values, integrity and trust, building effective teams, command skills, developing direct reports and others, drive for results and strategic agility
  • Proven track record of demonstrating collaboration and influencing skills across the organization at all levels
  • Excellent communication and interpersonal skills to ensure positive working relationships are developed and maintained with internal and external stakeholders, and bodies
  • Ability to lead, drive and motivate people to achieve goals
  • Ability to support and foster a diverse and multicultural group
  • Demonstrated ability to present complex technical topics to a wide range of audiences with varying technical depth
  • Flexible and adaptable attitude with the ability to support change management
  • Role model and promote CSL/Seqirus values
  • Experience managing teams of individual technical contributors (i.e. scientists, engineers) and direct reporting personnel in leadership roles (i.e. manager of managers) across multiple disciplines
  • Demonstrated experience establishing and building a high performing team through recruiting and personnel development