The Lead Scientist will manage the chromatography column packing, testing, and chromatography application operation. Develop Cambridge as the Chromatography Centre of Excellence within the Arcmed organisation, whilst actively contributing to the Omnifit commercial success within Arcmed. As the lead scientist specializing in chromatography column packing, principally for life science and biopharmaceutical research and production, you will develop and lead the team accountable for operations, ensuring the efficient, reliable, and profitable packing of chromatography columns for soft gel resin applications. This encompasses accountability for developing packing methodology and processes, optimizing packing techniques, meeting customer expectations, troubleshooting in support of Arcmed’s goal of further developing and growing the Omnifit brand position and commercial success in Chromatography.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Chromatography Column Packing Development:
- Prepare, assemble, pack and test chromatography columns with resins, gels, and other separation media based on:
- Establishing standardized protocols.
- Development of customized protocols for new columns and resins.
- Building complete technical documentation structure and support.
- Optimize specific column packing techniques to achieve a defined separation and purification target outcomes.
- Collaborate effectively with internal teams and external organizations to identify appropriate resins/column combinations and packing methods.
- Identify optimum instrumentation for an effective operation. Monitor instrumentation processes and performance.
- Build and maintain an effective group organization.
- Establish best practice QA/QC processes.
- Establish and promote “Good Lab Practice”.
- Establish Key Performance Indicators for the team and packing processes.
- Process Management:
- Design, implement, and maintain standardized protocols for the operation, to include staffing and general management of the operation.Ensure consistency and reproducibility within and between individual projects.
- Develop and implement procedures for purchasing, storing empty and packed columns and shipping of packed columns. Facility and equipment maintenance to include cleaning, sanitizing, solvent management, waste management.
- Regularly assess and optimize column packing processes, identifying areas for improvement and implementing corrective actions.
- Collaborate with cross-functional teams to integrate chromatography packing processes into internal adjacent Arcmed and external related projects.
- Document all procedures, in compliance with company protocols and ISO regulatory guidelines.
- Troubleshooting and Optimization:
- Report, document diagnose and resolve issues related to column packing and overall chromatography processes. Meeting both internal and external expectations.
- Carry out studies to optimize column packing parameters, resin characteristics and customer requirements.
- Analyze and interpret chromatography data to assess the quality of packing processes, separation efficiency and customer related purification processes.
- Provide technical expertise and support to both internal and external colleagues/teams/organizations in resolving chromatography related challenges.
- Continuously develop new methodology using optimization strategies, new technology and optimized manufacturing processes for best-in-class performance.
- Be a key member in Research & Development of new product designs to expand the organization’s existing portfolio.
- Develop Cambridge as the Chromatography Centre of Excellence within the Arcmed organisation.
- Actively contributes to the Omnifit commercial success in Arcmed.
- Training and Collaboration:
- Train junior scientists and technicians in column packing techniques, instrument operation, and other procedures.
- Collaborate with internal and external researchers, process developers, and other teams to integrate chromatography learned processes from other projects and workflows.
- Contribute to cross-functional discussions and decision-making to enhance overall process efficiency and product quality.
- Promote the dissemination of chromatographic market knowledge and interest internally.
- Other duties as assigned by manager.
This can include management of the laboratory, point contact for all regulations for a ‘wet laboratory’. Consolidation of market knowledge, competitor information, End-user records, Training schedules and distributor technical information and actively coordinating with the UK Sales Manager.
EDUCATIONAL REQUIREMENTS, QUALIFICIATIONS, and TRAININGS
- Ideally Ph.D. or master's degree in Analytical chemistry, Chemistry, Biochemistry, Chemical Engineering, or a related field, A first degree or similar with suitable experience will be considered.
- Several years of experience in packing columns with agarose, dextran and polymer soft gel resins is a benefit.
- Several years’ experience in running soft gel resin chromatography. Experience of working in process development in the pharmaceutical/biopharmaceutical industry will be a benefit.
- Strong understanding of chromatography principles, analytical software and related instrumentation, ideally experience with AKTA systems.
- Proficiency in troubleshooting chromatography issues and optimizing separation processes.
- Excellent organizational skills, attention to detail, and ability to work in a fast-paced research environment.
- Strong communication skills to effectively collaborate with internal and external multidisciplinary teams.
- Familiarity with regulatory guidelines and quality control practices in a scientific research or industrial setting.
- Must be able to communicate and build relationships across functions and at all levels of the organization with confidence and authority.
- Problem solving and analysis skills, making decisions quickly to improve performance.
- Ability to manage complexity and resolve conflicts that arise from balancing multiple priorities, utilizing project management skills to ensure clear visibility, accountability, and action tracking.
- Knowledge of quality systems and standards within an ISO 9001 approved organization.
- Desire and drive to improve business processes every day.
COMPUTER AND SOFTWARE REQUIREMENTS
- Microsoft: Office 365; SharePoint; Teams; Visio; and OneNote preferred.
- Working knowledge of UKG-UltiPro and Workday a plus.
- Ability to operate media equipment such as tablets, smartphones, and other electronic equipment.
- Ability to work with general office equipment.
- Ability to work with and understand databases a must and the ability to learn technical skills.
PHYSICAL REQUIREMENTS & WORK ENVIRONMENT
- Shall have adequate vision, reading, writing, and documentation skills, and hearing, to perform the essential functions of the job.
- Must have enough endurance to perform tasks over long periods of time.
- Will be engaged in speaking, sitting, walking, driving, listening, and in communicating both orally and in writing while performing his or her duties.
- Must be able to listen and respond to questions and instructions.
The qualifications, physical demands, and work environment described herein are representative of those an employee will encounter and must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.
This document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
The above noted job description is not intended to describe, in detail, the variety of tasks that may be assigned but rather to give the incumbent a general sense of the responsibilities and expectations of his/her position. As the nature of business demands change, so, too, may the essential functions of this position.
