Associate Director, Biologics Process Development Dublin
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research. This newly created role, Associate Director Biologics Process Development will join the Biologics development team.
The successful candidate will bring scientific and technical knowledge to the organization and support and manage elements of programs at various stages of development and in commercial manufacture.
This is a broad role where the successful candidate will support development and subsequent manufacturing of biological processes from cell line development through upstream and downstream processing. Since most of the development and manufacturing functions are performed outside the company, management of CMOs and CROs is a critical aspect of the job and will include frequent visits to contractors depending on the intensity of ongoing activities. The candidate will be able to recommend appropriate analytical methods and to interpret analytical data to understand process impact and measure process consistency.
The candidate will design and manage in-process stability studies and interpret stability data to establish in-process and DS storage times and limits. The candidate will design, manage and support process characterization studies and develop control strategies for process validation. The candidate will support process investigations and help determine root cause of excursions during development and commercial manufacturing.
Other responsibilities include cross-functional team membership, authoring technical protocols and reports, and writing / supporting CMC sections of regulatory dossiers.
The role involves significant cross functional collaboration with other functions, including Research and Development, Manufacturing, Regulatory and Quality, to ensure processes have a strong regulatory and technical foundation as well as being robust and well-controlled.
The role is both project and operations oriented that requires an ability to help drive and deliver elements of multiple projects running concurrently and apply current technologies. The position reports to the Director, Fermentation and Refining
- Manage and support development, scale-up, production and tech transfer of processes within or between CMO's.
- Design and manage cell line development, cell bank creation and safety and stability testing.
- Debottleneck and rationalize processes to optimize processes consistency, yield, and robustness.
- Generate, treat and analyse experimental data to support process observations/hypotheses.
- Ensure all experiments and activities are documented appropriately to ensure full traceability of work performed at the CMO/CRO.
- Contribute to preparation and submission of CMC portions of regulatory submissions and updates (IND, BLA, and post marketing commitments)
- Work effectively with team members and contractors both in person and remotely. Provide direction, support, and corrective action as needed.
- Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
- Have a high level of scientific curiosity and keep informed of technical developments within the industry by attending conferences and reviewing papers thus advocating a culture of continuous improvement.
- International travel of up to about 2 weeks at a time will periodically be required
Required Knowledge, Skills, and Abilities
- Over seven years of relevant biological process development and manufacturing experience with a strong record of achievement.
- Hands-on experience with culturing cells, operating microbial fermenters and/or mammalian bioreactors as well as harvesting material using centrifugation, depth filtration and/or TFF.
- In depth understanding of environmental, nutritional and mechanical factors influencing cell growth, productivity and longevity.
- Hands-on experience with purification techniques including operation of AKTA and UF/DF systems as well as analytical methodologies (SDS-PAGE, HPLC, spectrophotometry).
- In depth understanding of charge and size based separation mechanisms and manipulation of operating conditions for optimal separation of target protein from process and product related impurities.
- In-depth understanding of primary, secondary and tertiary protein structure and post translational modifications.
- Knowledge and experience of working with statistical programs (Minitab, JMP) for design and analysis of experiments.
- Demonstrated experience in tech transfer of a process from development to manufacturing or between manufacturing sites.
- Working knowledge of CMC regulatory requirements for biological pharmaceutical products at various stages of development as well as practical application of principles of QbD.
- Highly flexible, works well in a team environment, and has the skills necessary to organize, communicate and influence, with an unquestionable level of integrity.
- Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement.
- Ability to deliver objectives on time in pressurized, fast-paced environment, whilst also meeting all compliance, quality and cost targets.
- Knowledge of quality systems and FDA/EU regulations as they relate to process / product development and manufacturing of biologics.
- Experience in defending processes, procedures and investigations during FDA/EMA inspections – experience with preparation for PAI’s and inspection support a strong plus.
- Demonstrated technical proficiency, scientific creativity, and innovation individually and in collaboration with others.
Required/Preferred Education and Licenses
- Masters or degree in Science/Chemical Engineering or higher
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