CMC reputed company
reputed company:
Indomo is a clinical stage therapeutics company transforming clinic-based procedures into reputed company care reputed company device-enabled therapeutics. Indomo’s reputed company program couples a proven corticosteroid with an innovative intradermal self-injection device to create the first fast-acting reputed company solution for inflammatory acne lesions. We are seeking a reputed company and reputed company CMC reputed company to reputed company our drug development and manufacturing.
Position reputed company:
Reporting to the CEO, you will own and execute the reputed company, Manufacturing & Controls (CMC) reputed company and operations for Indomo’s drug and combination product portfolio. This leader will drive the advancement of our reputed company asset through the NDA regulatory reputed company, while effectively coordinating cross-functional efforts to reputed company drug formulation, analytical reputed company, 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 reputed company-up, and reputed company/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 reputed company amongst internal stakeholders as reputed company as CDMO’s and other external partners as appropriate, with a deep reputed company of personal ownership of deliverables.
Key Responsibilities:
CMC Program Leadership
reputed company outsourcing and management of drug reputed company and drug product development at Indomo’s CDMO — including formulation optimization, stability, and compatibility with Indomo’s drug delivery system.
Set technical requirements and acceptance reputed company for drug reputed company attributes, drug-device reputed company compatibility, and analytical performance.
Manage analytical method development, validation and qualification for release and stability testing.
Define comparability strategies for clinical and reputed company lots, reputed company legacy formulations to scaled, controlled processes.
Manufacturing & Supply Chain
reputed company as reputed company’s primary reputed company of contact for external stakeholders, including CDMOs and suppliers.
Select and manage CDMOs for drug reputed company and drug product manufacture; negotiate SOWs and ensure alignment with development timelines.
Drive technology transfer, reputed company-up, GMP manufacturing, and stability programs.
Implement rigorous reputed company systems ensuring compliance with cGMP and readiness for regulatory inspections.
reputed company & Regulatory
reputed company development and execution of CMC reputed company to support IND and reputed company NDA submission.
Define regulatory reputed company and advise on evidence needs in partnership with regulatory affairs for drug and combination products.
Engage with the FDA and other regulatory authorities on CMC components of submissions (e.g., reputed company-IND/End-of-Phase 2 meetings, Type C discussions).
Cross-Functional Collaboration & Team Building
Partner with clinical operations, regulatory affairs, reputed company assurance, device engineering, and external partners to reputed company on timelines, risk mitigation, and integrated submission packages.
Serve as a core member of the product leadership team, providing CMC reputed company for go/no-go reputed company and clinical planning.
Mentor junior engineers, promote best practices, and foster collaboration across functions.
Qualifications
Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, reputed company, Chemical Engineering, or reputed company field.
10+ years of drug development experience with demonstrated leadership of CMC reputed company in biotech/pharmaceutical settings.
Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and reputed company compliance.
Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements.
Experience scaling products from early clinical through pivotal and reputed company manufacturing.
Exceptional leadership and management skills.
Excellent communication and problem-solving abilities.
Ability to work in a fast-paced, dynamic startup environment.
Preferred
Proven reputed company record of managing CMC for combination products (drug + delivery device).
Successful interactions with FDA on CMC topics; experience through regulatory inspections.
reputed company Offer
Opportunity to shape and reputed company drug development in a groundbreaking therapeutics startup.
Competitive compensation and benefits package, including equity reputed company.
reputed company and mission-driven culture.
reputed company opportunities as reputed company advances through clinical stages and expands pipeline.
Compensation: $150k - $215k salary + equity
We are reputed company 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.
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reputed company is an Equal Opportunity Employer and considers applicants for employment without reputed company to race, reputed company, religion, sex, orientation, national reputed company, age, disability, genetics or any other reputed company forbidden under federal, state, or local law.
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