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Scientific Lead, Cmc Bioconjugation

2+ years
$121,500 to $178,200
10 Jan. 5, 2025
Job Description
Job Type: Full Time Education: BS/MS/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Title: Scientific Lead, CMC Bioconjugation
Location: Boulder, CO or Remote
Company: Lilly

Position Overview:

Lilly is seeking a highly innovative and experienced individual to join the CMC Biologics team to lead efforts in developing antibody-drug conjugates (ADC) for oncology. This role is pivotal in advancing the bioconjugation process and ensuring successful scale-up, optimization, and characterization for global regulatory approval.

Responsibilities:

  • Lead and manage bioconjugation development and manufacturing activities at third-party partners.
  • Collaborate with teams in discovery, process development, and analytical to deliver integrated clinical manufacturing solutions.
  • Develop bioconjugation strategies for clinical and commercial-scale manufacturing.
  • Provide scientific guidance and technical direction to third-party manufacturing partners.
  • Create and review technical reports and CMC documents for regulatory submissions, including IND, IMPD, BLA.
  • Work on product characterization and comparability studies.
  • Contribute to regulatory submissions, writing and reviewing sections for drug filings.
  • Support the development of strategies to meet quality-by-design (QbD) targets for bioconjugation processes.

Basic Requirements:

  • Education: BS degree in a relevant field; preference for Master’s or PhD candidates.
  • Experience: Minimum of 2 years of experience in the Biotech or Pharmaceutical industry, with a focus on bioconjugation.
  • Skills: Hands-on experience with bioconjugation techniques (cysteine/lysine conjugation, enzymatic, site-specific conjugation).
  • Regulatory Knowledge: Understanding of ICH/FDA/EMA guidelines and regulatory submission experience.

Additional Preferences:

  • Experience with ADC modalities and manufacturing processes.
  • Familiarity with structured process design, scale-up models, and process validation.
  • Excellent communication skills, both written and oral, for regulatory submissions and presentations.

Compensation:

  • Base Salary: $133,500 - $195,800, depending on education, experience, skills, and geographic location.
  • Bonus & Benefits: Company bonus eligibility, 401(k), pension, health insurance (medical, dental, vision), life insurance, paid time off, flexible spending accounts, wellness benefits, and more.

Work Environment:

  • Primarily office-based with <10% travel required.

Lilly is committed to equal opportunity and affirmative action, and provides reasonable accommodations for individuals with disabilities during the application process.