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Cmc Jobs (NOW HIRING)

Olema Oncology

Program Manager, CMC

San Francisco, CA · On-site

You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161.80K - $213.60K/yr

Serve as the CMC regulatory strategist and program leader, proactively identifying regulatory risks, opportunities, and mitigation strategies in alignment with development and commercialization ...

Olema Oncology

Program Manager, CMC

Boston, MA · On-site

You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with ...

Us tech Solutions

CMC Regulatory Manager

Morristown, NJ · On-site

CMC Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control (Module 3) documentation for the ...

Sanofi

GRA CMC Lead

Morristown, NJ · On-site +1

$154.30K - $203.70K/yr

GRA CMC Lead * Location: Morristown, NJ About the Job As GRA CMC Lead within our R&D team , you will be responsible for managing a portfolio of projects and/or marketed products. The GRA CMC Lead ...

CMC

Trailer Traffic Coordinator

Dallas, TX · On-site

At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills and offices that make us who we are as a company. Our success comes from finding ...

CSL Behring

GRA CMC Specialist

King Of Prussia, PA · On-site

Position Purpose The Head of Global Regulatory Affairs CMC - Network Strategy & Operation is responsible for: Partnering closely with global and regional Global Regulatory Affairs colleagues, as well ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161.80K - $213.60K/yr

The Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of ...

Sanofi

GRA CMC Lead

Morristown, NJ · On-site

$154.30K - $203.70K/yr

GRA CMC Lead * Location: Morristown, NJ About the Job As GRA CMC Lead within our R&D team , you will be responsible for managing a portfolio of projects and/or marketed products. The GRA CMC Lead ...

CMC

Logistics Specialist

Martinsburg, WV

At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills and offices that make us who we are as a company. Our success comes from finding ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210.50K/yr

Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine ...

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$13

$31

$67

How much do cmc jobs pay per hour?

As of May 30, 2026, the average hourly pay for cmc in the United States is $31.24, according to ZipRecruiter salary data. Most workers in this role earn between $19.23 and $36.54 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) professional, and why are they important?

To thrive as a CMC professional, you need expertise in pharmaceutical sciences, regulatory requirements, and process development, typically supported by a degree in chemistry, pharmacy, or a related field. Familiarity with regulatory submission systems, analytical tools, and quality management software is essential. Strong project management, attention to detail, and effective communication are vital soft skills for coordinating cross-functional teams and ensuring compliance. These skills and qualities are critical to guarantee the safety, efficacy, and regulatory approval of pharmaceutical products.

What are some common challenges faced by a CMC professional when coordinating between R&D, manufacturing, and regulatory teams?

CMC professionals often encounter challenges in aligning the timelines and priorities of R&D, manufacturing, and regulatory teams. Ensuring that product development meets both regulatory requirements and manufacturing feasibility can require extensive cross-functional communication and problem-solving. Additionally, adapting to evolving regulatory guidelines and integrating feedback from multiple stakeholders demands strong project management skills. Overcoming these challenges is essential for maintaining project momentum and ensuring successful product submissions.

What are CMC professionals?

CMC stands for Chemistry, Manufacturing, and Controls. CMC professionals are responsible for ensuring that pharmaceutical products are developed, manufactured, and controlled in compliance with regulatory standards. Their work includes overseeing formulation development, analytical testing, process validation, and documentation required for regulatory submissions. CMC experts play a critical role in bringing safe and effective drugs to market by ensuring product quality and consistency throughout the development and manufacturing process.

What is the difference between CMC vs Regulatory Affairs Specialist?

AspectCMCRegulatory Affairs Specialist
Required CredentialsBachelor's degree in life sciences, chemistry, or pharmacy; often additional certifications in pharmaceutical sciencesBachelor's degree in life sciences, pharmacy, or related field; certifications in regulatory affairs are common
Work EnvironmentLaboratories, manufacturing sites, and R&D departments within pharmaceutical companiesRegulatory agencies, pharmaceutical companies, and consulting firms
Industry UsageFocuses on drug development, manufacturing, and quality documentationFocuses on compliance, submissions, and communication with regulatory bodies

While both CMC and Regulatory Affairs Specialists work within the pharmaceutical industry, CMC professionals primarily handle the chemistry, manufacturing, and control aspects of drug development. Regulatory Affairs Specialists focus on ensuring compliance with regulations and managing submissions to authorities. Both roles often collaborate but serve distinct functions in bringing a drug to market.

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Cmc jobs near you
Infographic showing various Cmc job openings in the United States as of May 2026, with employment types broken down into 2% As Needed, 75% Full Time, 15% Part Time, and 8% Contract. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $64,986 per year, or $31.2 per hour.
Program Manager, CMC

Program Manager, CMC

Olema Oncology

San Francisco, CA • On-site

Full-time

Posted 13 days ago

Job description

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together for our patients, for your career, for what's beyond.
You can view our latest corporate deck and other presentations here.
About the Role >>> Program Manager, CMC
As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical development stages. You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance and external partners. You will serve as an operational leader - driving accountability, facilitating alignment, managing risk, and helping teams navigate challenges effectively.
This role can be based out of our San Francisco, CA or Boston, MA offices and will require 10% travel.
Your work will primarily encompass:
  • Lead integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), partnering with Director- and Senior Director-level functional leaders to define deliverables, timelines, and priorities aligned to clinical and regulatory goals.
  • Build and maintain integrated project timelines in Smartsheet (or similar tools), ensuring dependencies, critical path activities, and milestones are clearly defined and tracked.
  • Identify program risks, drive mitigation planning with functional leads, and escalate issues as needed to maintain timelines.
  • Facilitate CMC sub-team meetings, document decisions and action items, and ensure follow-through across internal teams and external partners.
  • Prepare leadership-ready status updates and presentations, track key program metrics, and maintain clear documentation of plans, risks, and decisions.
  • Support regulatory submission readiness by aligning CMC deliverables, documentation, and cross-functional inputs to filing timelines.
  • Partner with Technical Operations and CDMOs to drive coordinated execution and proactively identify risks to supply or compliance.
  • Strengthen CMC program management practices, tools, and planning processes to support scalable, efficient execution.
  • Provide program-level budget visibility and tracking in collaboration with functional leads and Finance.
  • Contribute to a collaborative, accountable, and team-oriented culture within CMC and across Olema.

Ideal Candidate Profile >>>
A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge:
  • Bachelor's degree required, Life Sciences or related disciplines preferred.
  • Proficiency in Microsoft Office Suite (PowerPoint, Excel, Outlook), Smartsheet (or equivalent PM tools), and collaboration platforms (e.g., MS Teams, SharePoint).
  • Knowledge of CMC development processes across clinical stages.
  • Familiarity with regulatory submission timelines and CMC documentation requirements preferred.

Experience:
  • Minimum 5+ years of experience in life sciences program management and/or drug development operations with a bachelor's degree, or 3+ years with a master's degree.
  • Experience driving CMC execution in early clinical-stage development (Phase 1-2), with exposure to Phase 3 readiness considered a plus.
  • Working cross-functionally within drug development teams (Drug Substance, Drug Product, Analytical, Quality, Regulatory Affairs, Supply chain).
  • Demonstrated experience building and managing integrated project plans, identifying critical path activities, and proactively managing risks and dependencies.
  • Collaborating and interacting with external vendors/CDMOs.
  • Experience preparing materials for team or leadership meetings.

Attributes:
  • Highly organized with strong attention to detail and follow-through.
  • Energetic, proactive, and action-oriented - a true "go-getter."
  • Friendly and approachable with a collaborative mindset.
  • Strong communicator who can tailor messaging to diverse audiences.
  • Skilled at bridging functions and building strong working relationships.
  • Comfortable navigating a fast-paced, evolving environment.
  • Solutions-oriented with sound judgment and appropriate escalation.
  • Strong team player who thrives in highly collaborative settings.

The base pay range for this position is expected to be $150,000-$170,00 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
#LI-MT1
Important Information >>>
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema's official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.

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