Senior Analytical Scientist

Eli Lilly and Company; Kinsale (VA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Analytical Scientist to lead analytical efforts in a dynamic environment. This pivotal role involves developing and validating advanced analytical methods, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to enhance manufacturing processes. The ideal candidate will possess deep expertise in analytical chemistry, particularly in separation sciences and mass spectrometry, and will thrive in a fast-paced, innovative setting. Join a team dedicated to making life better through cutting-edge healthcare solutions and contribute to impactful projects that change lives.

Qualifications

• Deep expertise in analytical chemistry techniques, especially in separation sciences.
• Proficiency in multiple instrument platforms and strong problem-solving skills.

Responsibilities

• Lead the development and validation of analytical methods for manufacturing.
• Support regulatory submissions and provide mentorship to team members.

Skills

Analytical Chemistry

Problem-Solving

Attention to Detail

Communication Skills

Team Collaboration

Education

BSc/MSc in Analytical Sciences

PhD/Post Doctorate in Analytical Science

Tools

Thermo Instruments

Agilent Instruments

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Senior Analytical Scientist provides the analytical leadership for all aspects of advanced analytical technologies and methods within the Analytical sciences/Quality control characterisation area.

The role will be responsible for provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and network projects. The development and validation of the methods and their associated lifecycle will be a key aspect of the roles. The assets involved may be small molecules, peptides, therapeutic proteins, drug conjugates and gene therapies within the new product introduction or commercial environment. The lifecycle management of existing technologies and instrumentation will be a further aspect of these roles. Given the increasing need for more in-depth molecule information and the increasing complexity of assets, the identification of and implementation of new or improved technologies will be required.

The role will be responsible for all the information generated that will be used to support manufacturing objectives. The active participation in cross functional teams within the internal/external manufacturing sites and development will be required to understand manufacturing and regulatory requirements while also providing the analytical technical leadership and perspective to meet the manufacturing goals.

Key Responsibilities:

• Support the introduction, validation and on-going technical agenda for pipeline and commercial analytical methods and technology.
• Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs.
• Execute and/or oversee testing protocols in accordance with local procedure and regulatory requirements.
• Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.
• As required provide training or mentorship to other QC or cross functional team members.
• Act as SME for one or more technologies and/or business systems within QC. This may include the identification, sourcing, installation, and qualification of new equipment.
• Will assure that all raw materials, in-process samples, intermediates or final products are appropriately analyzed and authorised. In the event of non-conformance to acceptable quality and/or safety standards, lead analytical investigations, using Root Cause Analysis techniques where appropriate. Ensure all associated countermeasures are complete. Work with onsite technical teams to improve the state of validation and drive analytical variability reduction.
• Support the writing of Annual Product Reviews (APRs) on Active Pharmaceutical Ingredients and Laboratory Periodic Review Reports (PRRs).
• Support and participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, Food and Drug Administration, etc.
• Be a role model for Analytical Sciences/Quality Control team members in terms of performance and behaviours.
• Influence the Business/external partners on critical issues to meet end goals – understand the external context/environment to achieve these goals.
• Attend and contribute to relevant technical fora.
• Proactively support management decisions and strategy.

Pre-Requisites (Includes experience, qualification etc.)

• Deep technical expertise in analytical chemistry techniques, in particular in separation sciences, biophysical and mass spectrometry techniques.
• With safety as the priority excellent laboratory techniques
  • Proficiency in the use of multiple instrument platforms (e.g. Thermo, Agilent, etc.)
  • Strong technical problem-solving ability both independently and as part of a team.
  • Motivated to work independently to produce high quality work product in an efficient manner.
  • High attention to detail in all aspects of the work.

Educational/Experience Requirements

• BSc/MSc Analytical Sciences (Chemistry or Biochemistry) with at least 5 years pharmaceutical analytical chemistry experience or PhD/Post Doctorate Level in Analytical Science (Chemistry or Biochemistry) with 3-5 years of recent bench experience in advanced analytics environment.

Additional Skills/Preferences:

• High learning agility and flexibility to achieve the required outcomes.
• Strong written and oral communication skills.
• Working knowledge in one or more of the following chemical, peptide or protein synthesis.
• Development and implementation of multi-attribute methods (PAT or offline).
• Imaginative approach to problem solving and solution discovery.
• Ability to resolve conflict, and promote good decision making among team members.

Key Attributes:

Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation, and organisational skills.

Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions.

Positive Influence: Demonstrated ability to address issues as they arise and act accordingly. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.

Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organisation.

Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.

Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.

Decision Making: Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.