Chemistry, Manufacturing, and Controls (CMC) Manager Job at I Peace, Inc.| Cell and Gene Therapy Manufacturing, cGMP iPS..., Palo Alto, CA

SGg0dWNCbEpmVndSS2lVTTFXNVNZbUhyRVE9PQ==
  • I Peace, Inc.| Cell and Gene Therapy Manufacturing, cGMP iPS...
  • Palo Alto, CA

Job Description

Join I Peace – Help Shape the Future of Regenerative Medicine

I Peace is a biotech startup leading innovation in personalized and regenerative medicine using iPSC technology. We manufacture and sell GMP-grade iPSC products and are preparing for clinical trials with iPSC-derived cell therapy products.We are currently hiring for a key role in Chemistry, Manufacturing, and Controls (CMC) Manager with a focus on FDA interactions.

Key Responsibilities:
  • Lead the preparation of materials for FDA Pre-IND and INTERACT meetings, including regulatory strategy, technical data summaries, and Q&A documents
  • Coordinate with cross-functional teams (CMC, QA/QC, R&D) to ensure accurate and timely regulatory submissions
  • Support clients with regulatory filings such as INDs
  • Develop and maintain Drug Master Files (DMF)
  • Manage internal QMS and ensure compliance with 21 CFR 210/211 and ICH Q7
  • Communicate regulatory requirements and product compliance effectively to external clients
Preferred Qualifications:
  • 5+ years of experience in Quality Assurance or Regulatory Affairs, including 3+ years in cell or gene therapy
  • Hands-on experience preparing documentation for FDA Pre-IND or INTERACT meetings
  • Strong understanding of GMP and regulatory compliance for biological products
  • Ability to work across U.S. and Japan teams and manage external consultants
  • Experience in client-facing regulatory communication and support

If you thrive in a venture environment and enjoy taking on new challenges, this is the perfect opportunity. At I Peace, we live by the philosophy: "We will either find a way or make one." We’re looking for a like-minded professional to join us on our mission.

Industry: Biotechnology Research

Employment Type: Full-time

If you or someone you know may be a good fit, we’d love to connect.

Job Tags

Full time, Currently hiring,

Similar Jobs

Ascension St. Vincent Hospital - Indianapolis - Ascension

Neonatology - Physician Job at Ascension St. Vincent Hospital - Indianapolis - Ascension

 ...Neonatology - Physician at Ascension St. Vincent Hospital - Indianapolis - Ascension summary: The position is for a board eligible/board certified Neonatologist to provide clinical care in Level III and IV NICUs at Ascension St. Vincent hospitals in Indianapolis and... 

Terra Kai Organics

Costco Sales Rep - Starting @ $21/hr Plus Bonus & Commission Job at Terra Kai Organics

 ...Seattle area: Seattle, Redmond, Silverdale, Tukwila & Everett Costco If you are into health and wellness, eating healthy, into fitness...  ...brand ambassadors make $160-$250 per day. Schedule: Part Time: 7.5 Hour shifts We start on 2 days a week (weekends) and increase... 

Pulmonary Associates of Brandon

Medical office manager Job at Pulmonary Associates of Brandon

 ...Supervise front and back office staff, fostering a positive and efficient work environment Manage scheduling, patient flow and clinical coordination Oversee billing...  ...policies Requirements 3-5 years of medical office or clinical management experience Clinical... 

NP Now

Vascular Surgeon Job at NP Now

 ...Job Description Job Description Big Texas non-profit Health System seeks a Vascular Surgeon in Longview TX! 1 hour and 45 mins from Dallas Join 800 Physicians! ****@*****.*** -(***) ***-**** Come make a difference within a growing team of... 

EWOR

EdTech Co-Founder / CTO (100 % remote) (m/f/d) Job at EWOR

 ...months (on average, EWOR Fellows raise > 2M after our Grand Pitch)TasksYou will own, build, and run your startup in fields such as EdTech.You will embark on an extensive personal development journey crafted by unicorn founders and follow a fully customised programme...