Atomic AI

Atomic AI

Drug CMC Lead

Remote - US · Exec

Sponsorship not specified$150k-$215kDetected 112 days ago
ComplianceSupply ChainGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs

About the role

  • Reporting to the CEO, you will own and execute the Chemistry, Manufacturing & Controls (CMC) strategy and operations for Indomo's drug and combination product portfolio.
  • The ideal candidate will be adept at building robust CMC packages that support clinical milestones and regulatory submissions.
  • This individual must be highly self-motivated, optimization-minded, and collaborative amongst internal stakeholders as well as CDMO's and other external partners as appropriate, with a deep sense of personal ownership of deliverables.

Responsibilities

  • Manage analytical method development, validation and qualification for release and stability testing.
  • Select and manage CDMOs for drug substance and drug product manufacture
  • Drive technology transfer, scale-up, GMP manufacturing, and stability programs.
  • Implement rigorous quality systems ensuring compliance with cGMP and readiness for regulatory inspections.
  • Lead development and execution of CMC strategy to support IND and eventual NDA submission.
  • We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.
  • We are focused on building a diverse and inclusive workforce.
  • Opportunity to shape and lead drug development in a groundbreaking therapeutics startup.

Requirements

  • 10+ years of drug development experience with demonstrated leadership of CMC strategy in biotech/pharmaceutical settings.
  • Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and quality compliance.
  • Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements.
  • Experience scaling products from early clinical through pivotal and commercial manufacturing.
  • Ability to work in a fast-paced, dynamic startup environment.
  • Proven track record of managing CMC for combination products (drug + delivery device).
  • experience through regulatory inspections.
  • Exceptional leadership and management skills.
  • Excellent communication and problem-solving abilities.
  • Preferred
  • Successful interactions with FDA on CMC topics

Nice to have

  • Advanced degree preferred in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.

Compensation

  • $150k - $215k salary + equity

Benefits

  • Competitive compensation and benefits package, including equity options.
  • Compensation: $150k - $215k salary + equity

Company info

  • Indomo is a clinical stage therapeutics company transforming clinic-based procedures into at-home care via device-enabled therapeutics. Indomo's lead program couples a proven corticosteroid with an innovative intradermal self-injection device to create the first fast-acting at-home solution for inflammatory acne lesions. We are seeking a versatile and experienced CMC Lead to lead our drug development and manufacturing.
  • Reporting to the CEO, you will own and execute the Chemistry, Manufacturing & Controls (CMC) strategy and operations for Indomo's drug and combination product portfolio. This leader will drive the advancement of our lead asset through the NDA regulatory pathway, while effectively coordinating cross-functional efforts to integrate drug formulation, analytical strategy, and manufacturing with the medical device component of Indomo's drug delivery system.
  • This role requires deep expertise in regulatory CMC requirements (especially drug product and formulation development, analytical method development/validation, manufacturing scale-up, and quality/regulatory interfacing for combination products). The ideal candidate will be adept at building robust CMC packages that support clinical milestones and regulatory submissions. This individual must be highly self-motivated, optimization-minded, and collaborative amongst internal stakeholders as well as CDMO's and other external partners as appropriate, with a deep sense of personal ownership of deliverables.
  • Indomo is a clinical stage therapeutics company transforming clinic-based procedures into at-home care via device-enabled therapeutics.
  • Indomo's lead program couples a proven corticosteroid with an innovative intradermal self-injection device to create the first fast-acting at-home solution for inflammatory acne lesions.
  • We are seeking a versatile and experienced CMC Lead to lead our drug development and manufacturing.
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