Top 914 Cmc program manager Jobs

Regulatory Affairs CMC Manager
Grove —Remote
- $75 - $80 an hour
- Full-time
- Remote
- Bachelor's degree
- Doctor of Philosophy
- Senior level
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Senior Global Program Manager
Viatris —Remote
- $95,000 - $193,000 a year
- Full-time
- Remote
- 7 years
- Writing skills
- English
Manager, Regulatory Affairs CMC
Iovance Biotherapeutics —Remote
- $140,000 - $160,000 a year
- Remote
- Microsoft Excel
- Bachelor of Science
- 8 years
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Senior Program Manager, CMC Portfolio Management
AbbVie —North Chicago, IL
- $124,500 - $236,500 a year
- Full-time
- Hybrid work
- Doctoral degree
- Microsoft Office
- Master's degree
- Paid holidays
- Health insurance
Senior Program Manager (mRNA LNP, Drug Product CMC/Development)
Aldevron —Fargo, ND
- $150,000 - $170,000 a year
- Full-time
- Remote
- Bachelor of Science
- Analysis skills
- Continuous improvement
- Health insurance
- Dental insurance
Senior Manager, Analytical Sciences - Commercial
Praxis Precision Medicines, Inc. —Boston, MA
- $147,000 - $167,000 a year
- Email
- 7 years
- Master's degree
- Bachelor's degree
Quick Apply
Sr. Manager, CMC Analytical Development
Asahi Kasei —Cary, NC
- $150,000 - $160,000 a year
- Full-time
- Hybrid work
- Microsoft Outlook
- Management
- Bachelor of Science
- Health insurance
12d
Sr. Manager, CMC Stability
Moderna, Inc. —Norwood, MA
- $130,800 - $209,400 a year
- Full-time
- Office
- Bachelor's degree
- Doctor of Philosophy
- Health insurance
- Paid time off
Sr. Manager, Regulatory Affairs
Vaxcyte —Remote
- $183,000 - $194,000 a year
- Remote
- Bachelor of Science
- Bachelor's degree
- Computer skills
Project Manager-ADC
InduPro Therapeutics —Seattle, WA
- $96.15 - $105.77 an hour
- Contract
- Remote
- Bachelor of Science
- Mid-level
- Office
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Associate/Sr. Associate - CMC Project Management & Operations
Oruka Therapeutics —Waltham, MA
- $104,000 - $146,000 a year
- Hybrid work
- Mid-level
- Office
- Bachelor's degree
Quick Apply
Sr Manager/Assoc Director, CMC Regulatory Affairs
Erasca —South San Francisco, CA
- $175,000 - $205,000 a year
- Remote
- 5 years
- Bachelor's degree
- Quality control
- Health savings account
- AD&D insurance
7d
Senior Director, Program & Portfolio Mngmt
Tonix Pharmaceuticals Inc —Berkeley Heights, NJ
- $200,000 - $300,000 a year
- Full-time
- Adults
- Office
- Analysis skills
- Health savings account
- AD&D insurance
Quick Apply
Senior Manager, Reference Standards & Reagents
Vera Therapeutics, Inc. —Remote
- $125,000 - $185,000 a year
- Remote
- Bachelor of Science
- 3 years
- Bachelor's degree
- Paid holidays
- Health insurance
Project Manager, THRIVE PERC Program
Broad Institute —Cambridge, MA
- $83,000 - $116,333 a year
- Full-time
- 5 years
- Bachelor's degree
- Doctor of Philosophy
- Health savings account
- Paid holidays
4d
Sr. Manager/Associate Director, Quality Control
Menarini Group —New York, NY
- $140,000 - $200,000 a year
- Bachelor of Science
- 3 years
- Analysis skills
- Health savings account
- AD&D insurance
Senior Project Manager - Associate Director, CMC
CALIDI BIOTHERAPEUTICS INC —San Diego, CA
- $125,000 - $165,000 a year
- Full-time
- Bachelor of Science
- Basic math
- Laboratory experience
- Health insurance
- Dental insurance
Quick Apply
Scientific Program Manager (Regulatory Affairs)
GAP SOLUTIONS INC —Bethesda, MD
- $110,000 - $125,000 a year
- Email
- Master's degree
- 8 years
- Organizational skills
Quick Apply
Project Manager, Discovery & Preclinical Development
Protagonist Therapeutics —Newark, CA
- $160,000 - $185,000 a year
- Mid-level
- 3 years
- Master's degree
Quick Apply
Manager/Sr. Manager QA Supply Chain
Oruka Therapeutics —Waltham, MA
- $146,000 - $187,000 a year
- Hybrid work
- Office
- 8 years
- Bachelor's degree
Quick Apply

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Regulatory Affairs CMC Manager

Grove -
Remote

Quick Apply

Job Details

Full-time | Contract
$75 - $80 an hour

Qualifications

FDA submissions
Biochemistry
Teamwork
Program management
Drug regulation
Bachelor's degree
Doctor of Philosophy
Compliance documentation
Chemistry, manufacturing & controls
Chemistry
Regulatory submission editing and review
Biomedical regulatory compliance
Cross-functional collaboration
Liquid chromatography machines
Cross-functional communication
Documentation reviews

Full Job Description

General Position Summary
The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy regulatory CMC strategies for marketed products. This role contributes to the planning, preparation and submission of regulatory CMC documentation. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable international regulatory requirements are considered and appropriately incorporated into the lifecycle of cell and gene therapy programs.
Key Duties & Responsibilities

Planning and execution of international regulatory CMC submissions, including creation of content plans and ensuring cross functional alignment 
Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
Contributes to the development of global regulatory CMC strategies for commercial products
Works with regulatory and technical colleagues to ensure timely submission and approval of CMC changes in the post approval environment
Provides regulatory CMC guidance to cross-functional teams and key stakeholders
Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Required Education Level & Experience

Strong interpersonal skills to exchange complex information with others and to guide others
Proficiency in FDA, EMA and international regulatory guidelines
Experience in the preparation, reviews and submissions of CMC post approval variations
Strong sense of planning, strategic thinking and problem-solving skills
Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
Capable of strategic thinking with ability to resolve complex and ambiguous situations
Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
5 years of Regulatory CMC experience, preferably in the biologics or cell and gene therapy field

Pay: $75.00 - $80.00 per hour

Experience:

LC-MS: 4 years (Required)

Work Location: Remote

Quick Apply

Refine Your Search

cmc program manager jobs

Regulatory Affairs CMC Manager

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