Sr. CMC Project Manager

Amino Collective; United States; A distancia; USD 135.000 - 150.000; Jornada completa

Descripción de la vacante

Enveda is seeking a Senior CMC Project Manager to own portfolio-level planning for CMC development of small-molecule assets. You’ll coordinate with internal teams and CDMOs across China, the EU and the US to keep timelines, budgets and regulatory submissions on track.

You’ll lead cross-functional initiatives, manage risk and drive streamlined workflows, with a startup mindset and strong attention to detail. This remote, full-time role offers substantial impact and growth opportunities.

Formación

• 5+ years of CMC project management in biotech/pharma.
• Experience with small-molecule drug development from IND-enabling through early clinical phases.
• Familiar with analytical method development, process chemistry, formulation, regulatory docs.
• Experience managing external CROs/CDMOs across geographies.
• Ability to lead cross-functional initiatives and manage timelines and budgets.

Responsabilidades

• Lead portfolio-level planning and execution of CMC development for multiple assets.
• Develop and own detailed CMC plans, budgets, and risk registers.
• Coordinate with CDMOs in China, EU, and US; oversee timelines and documentation.
• Chair cross-functional meetings; track actions and decisions.
• Communicate project status and risks across teams.

Conocimientos

CMC project management

Biotech/pharma

Cross-functional leadership

Budgeting

CDMO management

Regulatory submissions

AI in operations

Modern tooling

Educación

Bachelor's in Chemistry/Pharma

PMP certification

Herramientas

Smartsheet

Box

Domo

Slack

Zoom

Descripción del empleo

Let’s build the future of medicine - together.

Remote | Full-Time | $135,000 - $150,000

YOUR ROLE

As a Senior CMC Project Manager at Enveda, you'll own portfolio-level planning and execution of CMC development for our small-molecule assets, from initial tox supplies through Phase 2 scale-up across drug substance and drug product. You'll partner with our internal CMC team and with CDMOs across China, the EU, and the US to keep timelines, budgets, and regulatory submissions on track. Success in your first year looks like durable plans, risk registers, and workflows that let the CMC team move faster with more confidence. This is a high impact opportunity where you'll influence our small-molecule clinical pipeline while collaborating with some of the brightest minds in the industry.

WHAT YOU'LL DO

• Lead program-level and portfolio-level planning and execution of CMC development for multiple small-molecule assets, from initial tox supplies through scale-up, across drug substance and drug product
• Develop and own detailed CMC project plans and risk registers, and partner with internal and external teams to define and track development strategies, timelines, and deliverables, ensuring on-time, in-scope, and within-budget delivery
• Serve as the day-to-day primary point of contact for external CDMOs across China, the EU, and the US, and oversee CRO and CDMO planning, manufacturing campaign and batch execution timelines, and documentation deliverables
• Organize and chair recurring cross-functional and CDMO meetings with clear agendas, written minutes, and tracked action items, and support Project Leaders with agenda development, action tracking, and decision documentation
• Provide clear, concise communication of project status, risks, and mitigation strategies across internal teams and external partners
• Own the CMC proposal, purchase order, and change order pipeline for your assigned projects
• Maintain a rolling multi-year CMC budget forecast and historical spend model, overseeing commitments, accruals, and variance analysis down to PO line, program, activity stage, and budget item
• Operate and continuously improve a controlled, multi-stage CMC document review workflow
• Identify opportunities to accelerate timelines, streamline execution, and anticipate resourcing needs in a dynamic startup environment

WHAT WE'RE LOOKING FOR

• B.S., M.S., or Ph.D. (M.S. or Ph.D. preferred) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a similar field; PMP certification is a plus
• 5+ years of CMC project management experience in biotech or pharma, with hands-on exposure to small-molecule drug substance and drug product development from IND-enabling through early clinical phases; late-stage development experience is a plus
• Familiarity with small-molecule drug development, including analytical method development, process chemistry, formulation, and regulatory documentation
• Experience managing external CROs and CDMOs across multiple geographies, including planning, communication, quality of deliverables, and issue escalation and closure
• Demonstrated ability to lead cross-functional initiatives, set priorities, and manage timelines and budgets in a resource-constrained, fast-paced environment
• Proven ability to design and operate structured document workflows, approval processes, and standards in a GxP and submission-relevant context
• Experience or strong interest in applying AI and automation to operational workflows, with an emphasis on safety, transparency, and human oversight
• Strong technical and operational aptitude with modern tooling (Smartsheet, Box, Domo, Slack, Zoom) and comfort building or owning custom applications and integrations
• Excellent oral and written communication skills, with the ability to translate technical detail into clear project updates for diverse stakeholders
• A fast-paced, results-and-team-oriented start-up mindset, with flexibility, adaptability, and the resourcefulness to do more with less, plus excellent organizational, interpersonal, and problem-solving skills

We hire for trajectory, not just credentials. If you meet most of the above and care deeply about this problem, we want to hear from you.

ABOUT ENVEDA

We're a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than the industry standard. We recently raised $311M in a Series E, bringing total funding to over $845M, and doubled our valuation to $2B. We now have three oral medicines in the clinic, including our lead drug, ENV-294, in Phase 2 trials for eczema and asthma. Forbes named us one of America's Best Startup Employers, and Newsweek recognized us as a Top 100 Most Loved Workplace. We're still early, and most of the best work is ahead of us.

Benefits (Starting Day 1): Medical, dental, and vision covered at 90%, 401(k) with company match, flexible PTO and a company-wide weeklong recharge break, adoption assistance Our Process: We move fast and respect your time. Typically: a recruiter screen → hiring manager conversation → work sample, technical interview, & culture interview.

Our Values: Curiosity | Agency | Journey | Charity | Unity

At Enveda, we’re building a place where everyone can do the best work of their life. We are an equal opportunity employer and value diversity in all its forms. Join a team committed to shaping the future of drug discovery.

We care deeply about creating a safe, respectful experience for every applicant, so we wanted to share a few guidelines to help you spot anything that doesn’t feel right.

• You’ll always meet real Enveda team members through video or in-person conversations before receiving an offer.
• All communication from us will come from an @enveda.com or @envedabio.com email address.
• We’ll never ask you to purchase equipment, send money, or share sensitive banking details as part of any step in our recruiting process.

If something feels off or you’re unsure whether a message is truly from Enveda, please reach out at anytime at [e-mail].