Head of Protein Biochemistry

Job Description

A Head of Protein Biochemistry is required to join a growing Analytical Technologies/MS&T group based in West Dublin. This function supports commercial sites globally.

This position will report directly into the Director of Analytical technologies/MSAT.

The purpose of this role is to provide science and technology expertise and leadership in Analytical technologies and all associated aspects of characterisation technologies used in support of the development, heightened characterisation and commercial manufacturing of recombinant proteins.

You will also manage complex protein tech transfer and emerging market/localisation programs and use extensive knowledge of Comparability/Similarity assessments to ensure successful BoH submissions. This role will also plan and coordinate major mammalian protein process development and scale-up programs with both site and global network teams.

Responsibilities:

• Lead all activities associated with the resource planning and scheduling of technology transfers, localisation programs and technical support for commercial manufacturing processes and new product introduction programs and analytical pilot lab support for late stage mammalian protein process development programs, .
• Lead a dynamic team of experienced scientists supporting all activities associated with the analysis and heightened characterisation of various recombinant protein programs.
• Demonstrated ability to lead complex analytical technology transfer programs to both network and CMO partners.
• Responsible for the provision of technical subject matter expertise to the network Quality, Regulatory and Operation teams for complex laboratory and manufacturing investigations and tech transfers programs.
• Technical leadership for protein comparability/similarity assessments and development and authoring of regulatory submissions as required.
• Represent Analytical Technology in cross-functional teams in support of commercial and late stage development products.
• Provide technical leadership regarding the strategy and selection for qualification of new technologies across the company network.
• Strong emphasis on project and technical details as required, coupled with the ability to remain focused on the business needs.
• This position will also hold responsibility to identify and champion implementation and harmonization of technical programs/projects related to improving methods, laboratory operations, and new technologies applicable to in-process, characterisation and release testing and/or PAT applications.
• Participation with the Director and other senior members of the Analytical technologies team in the long-term strategic planning of all Analytical Technologies team activities.
• Representation of the Analytical Technologies team in the chosen technical field at inter-company project meetings, project meetings with third party partners, regulatory and scientific industry meetings.
• Develops ideas and leads/co-leads complex projects across Sub Business Unit/Sub Operating Unit
• Applies skills and discipline knowledge to contribute to the achievement of work within Sub Business Unit/Sub Operating Unit. Applies technical and line knowledge to plan/design projects that will enable the Sub Business Unit/Sub Operating Unit to meet goals.
• Participation with the Director and other senior members of the Analytical technologies group in developing, implementing and maintaining internal training programs.
• Ensure that all Analytical team members are trained in the appropriate Health & Safety and Environmental regulations.
• Participation with the Director and other senior members of the Analytical technologies team in ensuring that all Analytical laboratories remain in conformance with Health & Safety and Environmental regulations, to ensure that all staff work safely within the building.

Requirements:

• Minimum of 10+ years of lab-based experience in the biopharmaceutical industry with a relevant B.Sc./M.Sc./Ph. D.
• Education and technical fields of expertise should include the areas of: protein biochemistry, glyco-biology, analytical chromatography, various modes of Electrophoresis and mass spectrometry. Expertise in spectroscopy, microbiology, molecular biology, cell- and immunology-based bioassays, cell and gene therapy technology and drug stability studies also highly desired.
• Expertise in all aspects of analytical development and product characterisation programs for protein biotherapeutics.
• Proven experience of managing complex regulatory submissions required for new product introductions, tech Transfers, Biosimilar and localisation programs.
• Experienced in Regulatory dossier compilation and developing CMC responses.
• Experience in analytical method development, qualification and validation activities.
• Proficient with the use of a variety of problem-solving, risk analysis and statistical tools.
• Strong working knowledge of the Quality/GMP/ICH/compliance systems of the biopharmaceutical industry.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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