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Cmc In Biotech Jobs (NOW HIRING)

Director Regulatory Affairs CMC

Sonoma, CA · Hybrid

$168K - $221K/yr

Advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field (PhD preferred) * 10+ years of experience in Regulatory Affairs CMC within biotech or ...

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Cmc In Biotech information

What is the highest paying job in the biotech industry?

In the biotech industry, senior roles such as Vice President of Research and Development or Chief Scientific Officer typically have the highest salaries, often exceeding several hundred thousand dollars annually. These positions require extensive experience, advanced degrees, and leadership skills, and they oversee strategic research initiatives and regulatory compliance.

How is CMC used in pharmaceuticals?

In the context of CMC (Chemistry, Manufacturing, and Controls) in biotech jobs, CMC involves developing and controlling the processes for drug production, ensuring quality, safety, and efficacy. It includes activities like formulation development, process validation, and stability testing, which are essential for regulatory approval and manufacturing consistency.

What is the difference between Cmc In Biotech vs Formulation Scientist?

AspectCmc In BiotechFormulation Scientist
Required CredentialsBachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledgeBachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience
Work EnvironmentLaboratories, manufacturing facilities, regulatory settingsLaboratories, R&D departments, manufacturing units
Employer & Industry UsageBiotech companies, pharmaceutical firms, contract manufacturing organizationsPharmaceutical companies, biotech firms, contract labs

While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.

What is a CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing and producing a pharmaceutical product. CMC professionals ensure that drugs are manufactured consistently, meet quality standards, and comply with regulatory requirements, often working with laboratory techniques, quality assurance, and regulatory submissions.

What is the difference between CMC and GMP?

In biotech, CMC (Chemistry, Manufacturing, and Controls) refers to the documentation and processes ensuring a drug's quality, safety, and efficacy, while GMP (Good Manufacturing Practice) is a set of regulations that govern how drugs are produced to meet quality standards. CMC involves developing and controlling the product, whereas GMP ensures the manufacturing environment and procedures comply with quality requirements. Both are essential for regulatory approval and quality assurance in biotech roles like CMC specialists.
More about Cmc In Biotech jobs
What cities are hiring for Cmc In Biotech jobs? Cities with the most Cmc In Biotech job openings:
What states have the most Cmc In Biotech jobs? States with the most job openings for Cmc In Biotech jobs include:
Infographic showing various Cmc In Biotech job openings in the United States as of June 2026, with employment types broken down into 79% Part Time, and 21% Contract. Highlights an 82% Physical, 3% Hybrid, and 15% Remote job distribution.

Manager I, Program Manufacturing & Supply Chain

Welcome to the Tarsanet Internal Career Center!

Irvine, CA • Hybrid

$153K/yr

Other

Medical, Dental, Vision, PTO

Posted 18 days ago


Job description

About this Role

Reporting to Manager II, Program Manufacturing & Supply Chain, this role will work in concert with various stakeholders within Manufacturing, Supply Chain, Quality and Chemistry, Manufacturing & Controls (CMC) on planning and executing an array of projects. Some of these projects include commercial launches, commercial production optimization initiatives, technical transfers, and clinical supply production.

This person will require excellent communication and emotional intelligence to help lead cross-functional teams to achieve deliverables on time and within budget.  A successful candidate would have demonstrated, in previous experience, their ability to provide project management support within the Manufacturing, Supply Chain and CMC functions.

Let's talk about some of the key responsibilities of the role:

  • Work closely with cross functional teams including Manufacturing Operations, Supply Chain, Quality, CMC, and Program Management to ensure alignment and integration of timelines, requirements, and priorities.
  • Collaborates with and helps to manage external resources including contract manufacturing partners (e.g., CMO, CDMO) and consultants to ensure achievement of specified timelines, scope and deliverables.
  • Facilitates and organizes effective and efficient team meetings including scheduling, agenda setting, material preparation, key decisions, action items and minutes.
  • Create and maintain manufacturing batch timelines to ensure on-time delivery.
  • In concert with a cross-functional team, identifies and manages technical, operational, and quality risks as well as helps to develop mitigation measures and contingency plans.
  • Communicates decisions, status, risks, and issues within the technical teams and management, including appropriate escalation.
  • Accountable for tracking program budget versus actuals, including data collection, analysis, and ongoing assessment of financial performance.
  • Maintain and update program dashboards to reflect changes in timelines, scope, and budget, and proactively escalate variances or risks as appropriate.
  • Collaborate within integrated leadership operating models to support cross-functional decision-making, prioritization, and execution.
  • Contributes to the standardization of PM best practices at Tarsus.

Factors for Success:

  • Bachelor of Science in one of the relevant Engineering or Science fields.
  • Minimum of 5 years working in Manufacturing, Supply Chain, and/or CMC in biotech or pharmaceutical industry, with at least 2 years of success in a project management role.
  • Good understanding and experience of pharmaceutical manufacturing and CMC with respect to GMP, quality systems, ICH guidelines, FDA and associated regulatory requirements.
  • Experience in aseptic manufacturing preferred, but not required.
  • Experience successfully managing third party contractors is highly preferred contract manufacturing organizations.
  • Ability to negotiate and sustain networking relationships in a matrix environment
  • The successful candidate will have demonstrated experience in leading cross-functional teams.
  • Proficient use of IT / project management tools (Outlook, Excel, MS Project)
  • Excellent communication, influencing, stakeholder management and decision-making skills
  • Strong project / program management foundation (PMP preferred)
  • Tarsus Competencies:
    • Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
    • Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
    • Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.

A Few Other Details Worth Mentioning:

  • The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option.
  • We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
  • This position reports directly to Manager II, Program Manufacturing & Supply Chain.
  • Some travel may be required - up to 10%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $109,500 - $153,300 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

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