ZipRecruiter

Log In

1

Cmc Reviewer Jobs in Florida (NOW HIRING)

ST ANDREWS COUNTRY CLUB

Pastry Cook

Boca Raton, FL · On-site

$20 - $24/hr

This position will gain experience by working with and around Chef Joseph Leonardi, CMC, AAC, who ... Reviews requests for banquets and restaurants by reading function sheets * Creates special order ...

ST ANDREWS COUNTRY CLUB

Pastry Cook

Boca Raton, FL · On-site

$20 - $24/hr

This position will gain experience by working with and around Chef Joseph Leonardi, CMC, AAC, who ... Reviews requests for banquets and restaurants by reading function sheets * Creates special order ...

next page

Showing results 1-20

All JobsCmc Reviewer JobsCmc Reviewer Jobs in Florida

Cmc Reviewer information

What is a CMC reviewer?

CMC Reviewers are professionals who evaluate the Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions for pharmaceuticals and biologics. Their main responsibility is to ensure that products are manufactured consistently and meet quality standards required by regulatory agencies such as the FDA. They assess data on product composition, manufacturing processes, quality control, and stability to ensure compliance with regulations. CMC Reviewers play a critical role in the drug approval process by helping to ensure the safety, efficacy, and quality of new therapies.

What are the key skills and qualifications needed to thrive as a CMC reviewer?

To thrive as a CMC Reviewer, you need in-depth knowledge of chemistry, manufacturing, and controls (CMC) regulations, as well as a degree in pharmacy, chemistry, or a related scientific field. Familiarity with regulatory submission systems like eCTD, and experience with ICH guidelines and FDA/EMA standards, are typically required. Strong attention to detail, critical thinking, and effective communication skills help reviewers assess complex data and collaborate with cross-functional teams. These capabilities ensure regulatory compliance and product quality, facilitating timely drug approvals and patient safety.

What are some common challenges faced by CMC reviewers in coordinating with cross-functional teams during the regulatory submission process?

CMC Reviewers often encounter challenges in aligning documentation and data from various departments such as manufacturing, quality control, and research. Differences in terminology, documentation standards, and timelines can cause delays or inconsistencies in submissions. Effective communication, proactive project management, and a strong understanding of regulatory requirements are crucial for ensuring all contributions meet submission standards and deadlines. Building strong relationships with stakeholders and establishing clear documentation processes can help mitigate these challenges.

What is the difference between Cmc Reviewer vs Cmc Associate?

AspectCmc ReviewerCmc Associate
Required CredentialsBachelor's degree, often in life sciences or chemistry; relevant experienceSimilar educational background; entry-level or junior role
Work EnvironmentRegulatory or pharmaceutical companies, quality assurance teamsSame industry, often in early career stages
Employer & Industry UsageUsed in biotech, pharma, and regulatory sectors for review rolesCommonly a starting position in CMC departments
Comparison Search IntentUnderstanding seniority and responsibilitiesEntry-level role, learning responsibilities

The main difference between a Cmc Reviewer and a Cmc Associate lies in experience and responsibility. Cmc Reviewers typically have more experience and are responsible for critically evaluating CMC documentation, while Cmc Associates are often entry-level, supporting review processes. Both roles require similar educational backgrounds and are integral to pharmaceutical and biotech industries.

What are popular job titles related to Cmc Reviewer jobs in Florida?

For Cmc Reviewer jobs in Florida, the most frequently searched job titles are:

What job categories do people searching Cmc Reviewer jobs in Florida look for?

The top searched job categories for Cmc Reviewer jobs in Florida are:

Cmc Reviewer jobs near you

Associate Director/Director, CMC Analytical Development, Separation

Syncromune

Fort Lauderdale, FL • On-site, Remote

$165K - $200K/yr

Full-time

Re-posted 27 days ago

Job description

The Associate Director/Director of CMC Analytical Development will oversee the execution of the analytical strategy for drug substance and drug product development across all phases of clinical development and commercialization. This role is responsible for overseeing method development, validation, transfer, and lifecycle management to ensure compliance with regulatory requirements and alignment with company objectives.
Principal Duties and Responsibilities include the following:
  • Define and implement analytical development strategies to support CMC programs from early development through commercialization.
  • Provide technical leadership in analytical sciences, including chromatography, spectroscopy, and characterization techniques.
  • Guide analytical development activities at CDMO and CTL, including method development, optimization, transfer, validation, troubleshooting, and lifecycle management for GMP test methods for DS and DP.
  • Guide extended characterizations in support of comparability and regulatory applications.
  • Foster collaboration with cross-functional groups including Process Development, Quality, and Regulatory Affairs.
  • Author and review analytical sections of regulatory submissions (IND, IMPD, NDA, BLA).
  • Ensure adherence to GMP, ICH, and FDA guidelines for analytical activities.
  • Drive continuous improvement and innovation in analytical technologies and processes.
Supervisory Responsibilities:
  • Indirect Reports: supervise CDMO, CTL, and external resources (such as consultants)
Qualification Requirements:
Education:
  • Ph.D. or M.S. degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field.
Experience:
  • Must have 8+ years of pharmaceutical or biotechnology industry experience specializing in analytical development.
  • Must have working knowledge of cGMP, ICH, and regulatory guidelines.
  • Must have hands-on experience managing global CTLs and CDMOs.
  • Must have strong technical expertise in separation science, such as liquid chromatography or mass spectrometry.
  • Must have strong technical experience in at least one of the modalities: monoclonal antibody and/ or oligonucleotide.
  • Must have experience in method development, validation, and lifecycle management for QC methods.
  • Good to have experience in complex drug products, such as co-formulation, multi-components, conjugates, etc.
  • Good to have experience in extended characterization & comparability studies to support BLA submission.
  • Good to have experience in authoring technical and scientific documents for regulatory submissions, including IND and BLA filings.
  • Good to have late phase experience, such as PPQ and commercialization.
  • Candidates proficient in both English and Mandarin are highly encouraged to apply.
  • Ability to work in a fast-paced virtual environment.
  • Flexibility to travel domestically and internationally as required.
  • Excellent communication, leadership, organizational and project management skills.
Working Conditions:
  1. Specify work environment:
  • Work from home.
  • Domestic and international travel up to 25%.
  • Regularly required to stand, sit, talk, hear, and use hands
  • Prolonged periods of sitting and standing

Syncromune is an Equal Opportunity Employer.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range for Assoc Director and Director levels: $165-$245K
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company's benefit plans.
#Remote

Apply