Director, Process Development
Our client is a pharmaceutical company. They have asked us to assist them in a search for a Director, Process Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Develops and implements the process development strategy for an influenza vaccine antigen process.
- Leads own team and collaborates with partner functions to deliver on process and product development strategies.
- Leads technical teams developing bioprocesses to increase yield and capability.
- Directs and integrates development projects across disciplines to deliver program goals.
- Responsible for developing and demonstrating process improvements and is accountable for collaborating with Operations to drive implementation of improvements in manufacturing.
- Authors key technical documentation.
- Writes technical content for CMC sections of regulatory license documents.
- Identifies opportunities to enhance bioprocess development projects.
- Identifies collaboration opportunities.
- 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 team strategy and structure to meet program goals.
- Maintains a state of compliance for team and self.
- Provides feedback, technical guidance, and mentorship to the process development team.
- Partners with Operations to transfer processes into manufacturing and provides technical support during key tech transfer and validation activities.
- Provides 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.
- Produces high quality technical presentations for internal audiences to update on project technical progress.
- A postgraduate degree is required. A PhD is preferred.
- A minimum 8 years of experience in biological drug discovery or development is required.
- Must have broad technical expertise in bioprocess design and development.
- Must have experience managing teams of individual technical contributors and direct reporting personnel in leadership roles across multiple disciplines to deliver complex projects.
- Requires expertise in process engineering scale up and scale down principles and techniques.
- Experience in media and cell line development is ideal.
- Experience in virology concepts and virus cultivation is ideal.
- Must have experience in drug product formulation development and combination products.
- A working knowledge of analytical methods used for characterization of bioprocesses is required.
- Must have a working knowledge of exploratory data analysis and statistical techniques.
- Experience writing content for technical documentation is required.
- The demonstrated ability to present complex technical topics to a wide range of audiences with varying technical depth is required.
- Must have a proven track record of demonstrating collaboration and influencing skills across the organization at all levels.
- Demonstrated experience establishing and building a high performing team through recruiting and personnel development is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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