Principal/Senior Principal Downstream Bioprocess Scientist

The Principal/Senior Principal Downstream Bioprocess Scientist required for pharma client based in Limerick.

The successful applicant will have technical expertise in downstream bioprocessing and experience in data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process performance by implementing new technologies and process improvements. They will maximize the benefits of a digital plant to gain in depth knowledge of the process through data analytics and process analytical technology.

Responsibilities:

• In-depth knowledgeable of the science of downstream cell culture processes and understand molecule-specific control strategy and basis of specifications and critical attributes

• Understand purpose and capability of each downstream unit operation and the impact of equipment on the process

• Provide technical expertise to the online process support team for process science, operational excellence and compliance

• Work as part of a cross-functional team at the interface between quality assurance, operations and engineering to bring deep technical expertise and scientific rigor to the team

• Utilize process monitoring tools to make data driven decisions to ensure process consistency and robustness

• Understand basic statistical methodologies engage with statisticians to assign specifications, validation acceptance criteria, tech transfer criteria, material sampling criteria, comparability assessments and analysis of batch data for summary reports and product reviews

• Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance and process monitoring needs are captured in manufacturing electronic documentation

• Identify process improvements and participate in implementation of Lean Manufacturing initiatives

• Generate scientific reports and technical documentation

• Understand and ensure compliance with safety, compliance, and regulatory expectations

• Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies

Requirements:

• Demonstrated technical capability with high productivity

• Proven track record of curiosity with learning agility

• Self-starter with high initiative and data-driven approach to problem-solving

• Demonstrated strong interpersonal skills

• Demonstrated strong verbal and written communication skills

• Demonstrated adaptability and flexibility to working in different environments, teams etc.

• Demonstrated ability to participate in and facilitate decision-making

• Bachelors, Masters or PhD qualification in relevant scientific discipline such as Engineering, Biology, Chemistry, Microbiology, etc.

• Minimum of 5 years’ experience in the Biopharmaceutical industry

Please call James Farrar today for further information on 0872489961 or email: jfarrar@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.