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Eli Lilly and Company · 3 months ago

Senior/Principal Scientist TSMS APIEM TIDES

US, Indianapolis IN

Full-time

Onsite

Senior Level, Lead/Staff

$66K/yr - $172K/yr

3+ years exp

Eli Lilly and Company is a global healthcare leader dedicated to improving lives through discovery and innovation. The Senior/Principal Scientist in the Technical Services/Manufacturing Sciences team will provide technical oversight for the manufacturing of peptide and oligonucleotide processes, ensuring compliance with global standards and effective problem resolution.

BiotechnologyHealth CareMedicalPharmaceutical

No H1B

Responsibilities

Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing processes

Leads resolution of technical issues including those related to control strategy and manufacturing

Employ excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs

Build and maintain relationships with development partners and central technical organizations

Ensure proper characterization of processes and ensure effective documentation and justification of the process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability

Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring. Identify any leading signals of process weakness from yield/quality standpoint and proactively resolve/escalate

Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose

Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks in place. Demonstrate a structured approach to problem solving and investigation

Support regulatory submissions with technical input as required, author and review annual reports to regulatory agencies and maintain awareness of regulatory best practices

Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place

Maintaining peptide/oligonucleotide processes in a state of compliance with US and global regulations

Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment

Operate with ‘Team Lilly’ in mind - including coaching and mentoring of peers and other scientists

Qualification

Pharmaceutical manufacturingRegulatory requirementsTechnical oversightProcess monitoringProject ManagementCritical thinkingCommunication skillsTeam spiritProblem solving