Analytical Technical Steward Peptides and Oligonucleotides
Eli Lilly and Company
4 hours ago
On-site
Indianapolis, IN
$65,250 - $169,400 USD yearly
Operations
Responsibilities:
- Perform technical review, interpretation, and release of analytical data (CM, stability, process validation, reference standards) to predetermined standards.
- Lead/perform investigations of OOS and aberrant data; conduct root-cause analyses and recommend corrective/preventive actions.
- Develop investigational testing protocols; coordinate testing across sites for batch release, stability, process validation, and single batch verification.
- Support APR, tech transfer, and process validation.
- Assess and approve analytical test method packages: method assessments, protocol approvals, and approvals/changes/deletions to test methods.
- Provide QC laboratory support for marketed products (method development/validation/improvements; training/transfer; change controls; regulatory submissions).
- Manage method change control, reference standard evaluations, monograph review/implementation, and analytical method transfers to contract manufacturers/third-party QC labs.
- Ensure consistent practices between laboratories and manage multiple projects.
Basic qualifications:
- Bachelor’s degree in a science field (e.g., Chemistry, Biochemistry, Pharmacy) or equivalent experience.
- 5+ years pharmaceutical GMP lab experience; Large Molecule, Peptide, and/or Oligonucleotide strongly preferred.
- Work authorization in the US required (Lilly will not sponsor).
Preferred skills/knowledge:
- Proficiency in complex lab analysis (HPLC/GC, spectroscopic, bioassay, compendial, LC-MS).
- Compliance/regulatory understanding; coaching/influencing ability.
- Root cause analysis training; strong communication and cross-functional collaboration.
- Experience with method qualification/validation/transfer; GMP/CS equipment and CSV.
- QC support for contract manufacturers of starting materials/intermediates/APIs.
Additional information/requirements:
- Indianapolis, IN; may require lifting 5 liters, 24-hour cell coverage, ~20% travel overseas; complete applicable Learning Plan requirements.
Benefits (as stated):
- Eligibility for 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, certain time off/leave, and well-being benefits (e.g., EAP, fitness, employee clubs).
- Perform technical review, interpretation, and release of analytical data (CM, stability, process validation, reference standards) to predetermined standards.
- Lead/perform investigations of OOS and aberrant data; conduct root-cause analyses and recommend corrective/preventive actions.
- Develop investigational testing protocols; coordinate testing across sites for batch release, stability, process validation, and single batch verification.
- Support APR, tech transfer, and process validation.
- Assess and approve analytical test method packages: method assessments, protocol approvals, and approvals/changes/deletions to test methods.
- Provide QC laboratory support for marketed products (method development/validation/improvements; training/transfer; change controls; regulatory submissions).
- Manage method change control, reference standard evaluations, monograph review/implementation, and analytical method transfers to contract manufacturers/third-party QC labs.
- Ensure consistent practices between laboratories and manage multiple projects.
Basic qualifications:
- Bachelor’s degree in a science field (e.g., Chemistry, Biochemistry, Pharmacy) or equivalent experience.
- 5+ years pharmaceutical GMP lab experience; Large Molecule, Peptide, and/or Oligonucleotide strongly preferred.
- Work authorization in the US required (Lilly will not sponsor).
Preferred skills/knowledge:
- Proficiency in complex lab analysis (HPLC/GC, spectroscopic, bioassay, compendial, LC-MS).
- Compliance/regulatory understanding; coaching/influencing ability.
- Root cause analysis training; strong communication and cross-functional collaboration.
- Experience with method qualification/validation/transfer; GMP/CS equipment and CSV.
- QC support for contract manufacturers of starting materials/intermediates/APIs.
Additional information/requirements:
- Indianapolis, IN; may require lifting 5 liters, 24-hour cell coverage, ~20% travel overseas; complete applicable Learning Plan requirements.
Benefits (as stated):
- Eligibility for 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, certain time off/leave, and well-being benefits (e.g., EAP, fitness, employee clubs).