DESCRIPTION OF A SENIOR PRINCIPAL SCIENTIST (BIOANALYTICAL)
ROLE
The Senior Principal Scientist (Bioanalytical) is a technical leader who provides analytical leadership for all aspects of bioanalytical technologies and methods in Quality Control. This role is responsible for the provision of analytical methods, data, and information using analytical techniques to support site manufacturing processes and network projects.
KEY RESPONSIBILITIES:
1. Lead the introduction, validation, and ongoing technical agenda for pipeline and commercial analytical methods and technology.
2. Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs.
3. Execute and/or oversee testing protocols in accordance with biosafety, local procedure, and regulatory requirements.
4. Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.
5. Develop strong links with Bioproducts Research and Development and participate in the development and transfer of new techniques and methodologies.
6. Provide training or mentorship to other QC or cross-functional team members as required.
7. Act as SME for molecular and chromatographic-based analytical technologies, including identification, sourcing, installation, and qualification of new equipment.
8. Ensure all samples are appropriately received, stored, analyzed, and disposed of, including testing outsourced to third parties.
9. Lead and document analytical investigations using Root Cause Analysis techniques in the event of non-conformance to acceptable quality and/or safety standards.
10. Keep abreast of relevant scientific literature, new technologies/capabilities, and regulatory initiatives/requirements and support their implementation as appropriate.
11. Support the writing of Annual Product Reviews (APRs) and Laboratory Periodic Review Reports (PRRs).
12. Participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities and Food and Drug Administration.
LEADERSHIP/SITE MANAGEMENT:
1. Proactively support management decisions and strategy.
2. Be a role model and mentor for Quality Control team members in terms of performance and behaviors.
3. Influence business/external partners on critical issues to meet end goals.
4. Attend and contribute to relevant internal and external technical forums.
REQUIREMENTS:
Candidates must be able to travel to US-based locations for familiarization and training. Duration and frequency will be dependent on experience levels and site goals.
- Excellent laboratory techniques with safety as the priority.
- Deep technical expertise in molecular and chromatographic techniques with the ability to interpret and understand the outcome of and linkages between experiments.
- Strong technical problem-solving ability both working independently and as part of a team.
- Motivated to work independently to produce high-quality work effectively.
- High attention to detail in all aspects of the work.
EDUCATIONAL/EXPERIENCE REQUIREMENTS:
- BSc/MSc/PhD in Biochemistry, Molecular Biology, Cellular Biology, Biology, or related field with a minimum of 7 years of recent experience, preferably in a QC laboratory environment.
- Experience with molecular testing, such as ELISA assays, qPCR assays.
- Experience with separation testing, such as HPLC, UPLC, CE, iCIEF assays.
ADDITIONAL SKILLS/PREFERENCES:
- Strong written and oral communication skills.
- Ability to work independently, self-sufficiently, and proactively in the performance of work duties.
- Ability to resolve conflict and promote good decision-making among team members.
- High learning agility and flexibility to achieve the required outcomes.
- Imaginative approach to problem-solving and solution discovery.
KEY ATTRIBUTES:
- Business Knowledge: High performance in delivery of their work. Looks for better, simpler ways, takes initiative, and runs proactively with actions.
- Learning Agility and Curiosity: High learning agility and flexibility, ability to deal with ambiguity and uncertainty.
- Positive Influence: Ability to address issues as they arise and take action.
- Relationship Builder: Ability to establish and maintain key relationships across all levels in the organization.
- Ability to Lead People: Ability to lead and motivate in a team environment.
- Communication: Strong communication skills, written and oral in 1:1 and group situations.
- Decision Making: Ability to be decisive and make well-informed decisions for the benefit of the team.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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