Senior Scientist, Analytical Development CMC 1

SERB Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 470 employees in 16 countries and a group revenue in excess of €350m. Our portfolio of 80+ rescue medicines makes a real difference in the lives of patients and their caregivers, giving every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

• We make patients our priority
• We act with integrity and accountability
• We work together as one team
• We look for better ways forward

Broad Function

To develop analytical methods and studies to support clinical and commercial manufacturing and lifecycle management activities. Responsible for general duties and upkeep of the analytical development laboratory and supervision of scientists.

• Supervise the development and validation of analytical techniques to support manufacturing and commercial activities of new and established biological products.
• Supervise the characterization of new and established products as part of lifecycle management projects.
• Experienced in developing studies using techniques such as U/HPLC, binding assays (SPR Biacore, BLI, ELISA), SDS, and Circular Dichroism.
• Maintain and develop state-of-the-art knowledge applicable to existing and future processes and maintain up-to-date knowledge on regulatory expectations.
• Act as the scientific interface between BTG and 3rd parties for technical discussions surrounding the development of new scientific techniques.
• Support the development of novel methodologies for new and existing processes.
• Develop, validate, and transfer analytical methods to internal and external laboratories to support product manufacture.
• Responsible for the supervision and training of scientists within analytical development.
• Represent the CMC team at project team meetings and provide expert technical advice in analytical issues to QC and manufacturing.
• Responsible for the housekeeping of the laboratory and instrumentation to ensure the timely and accurate generation of data.
• Ensure all activities follow standard operating procedures and/or protocols and, where appropriate, are performed in compliance with GxP.
• Independently design, plan, and manage own studies.
• Represent the company at external seminars and supplier visits as required.
• Input into the formulation of budgets related to projects and department.
• Work with other departments to resolve issues and implement corrective actions.
• Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BTG values.
• Carry out other reasonable tasks as required by the Technical Lead or Manager.

The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Principal Relationships

• Accountable to – Lead, CMC.
• Responsible for – Scientists as required.
• Liaise with internal personnel at all levels of the business as required.
• Liaise with external 3rd parties as required.

Education and Experience

• Educated to degree level in an appropriate scientific discipline.
• Significant experience in analytical development in a biopharmaceutical or closely related industry and strong knowledge of regulatory requirements.

Skills and Attributes

• Competent and organised with the ability to perform multiple tasks concurrently.
• Strong ability to undertake continuous learning of scientific techniques and industry expectations.
• Ability to work closely with others, encourage good team spirit, and demonstrate initiative as required.
• A dynamic, flexible, and willing attitude with the desire to continually improve and develop both self and junior colleagues.
• Strong communication skills with the ability to deliver and follow instructions and guidance.
• Methodical, organised with an aptitude for detail.
• Able to take responsibility and give direction as required.

SERB Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities, and a culture of working together in a supportive way built on our strong foundation of values.