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Analytical Development Biotech Jobs in Florida (NOW HIRING)

Capstone Search Partners

Patent Agent

Miami Beach, FL

$110K - $210K/yr

... development, portfolio management, and competitive landscape analysis for clients in the biotechnology and pharmaceutical industries. * Monitor industry trends, scientific advancements, and ...

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Analytical Development Biotech information

What are some typical challenges faced by Analytical Development professionals in the biotech industry?

Analytical Development professionals in biotech often encounter challenges such as developing robust methods for novel biologics, ensuring regulatory compliance, and adapting to rapid technological changes. They frequently work within cross-functional teams, collaborating closely with research, manufacturing, and quality assurance groups to optimize assay performance and troubleshoot issues. Staying current with evolving regulatory standards and balancing project timelines with method validation requirements are also common aspects of the role.

What is the difference between Analytical Development Biotech vs Quality Control Analyst?

AspectAnalytical Development BiotechQuality Control Analyst
CredentialsBachelor's/Master's in Life Sciences, Chemistry, or related fieldsBachelor's in Chemistry, Biology, or related fields; often requires GMP training
Work EnvironmentResearch labs, development departments, collaborative teamsQuality labs, manufacturing facilities, compliance-focused settings
Industry UsageDeveloping and optimizing analytical methods for biotech productsTesting and ensuring product quality and compliance with standards

Analytical Development Biotech focuses on creating and refining analytical methods during product development, while Quality Control Analysts primarily test products to ensure they meet quality standards. Both roles require similar educational backgrounds and work in laboratory settings, but their core responsibilities differ in the product lifecycle.

What is Analytical Development in biotech?

Analytical Development in biotech refers to the process of designing, developing, and validating methods to analyze biological products, such as proteins, antibodies, or cell therapies, during various stages of drug development and manufacturing. These methods are essential for ensuring the safety, quality, potency, and purity of biotechnological products. Professionals in this field work closely with research, production, and regulatory teams to ensure that analytical methods meet industry standards and comply with regulatory requirements. Analytical Development is a critical part of bringing new biopharmaceutical products from the lab to the market.

What are the key skills and qualifications needed to thrive as an Analytical Development Biotech professional, and why are they important?

To thrive as an Analytical Development Biotech professional, you need a strong background in analytical chemistry, biochemistry, or a related field, typically supported by at least a bachelor's or master's degree. Familiarity with analytical instrumentation such as HPLC, GC, mass spectrometry, and relevant quality systems like GMP or ICH guidelines is crucial. Strong problem-solving, attention to detail, and effective communication are important soft skills for collaborating across multidisciplinary teams. These competencies ensure accurate data generation, regulatory compliance, and successful development of biotechnological products.
What are popular job titles related to Analytical Development Biotech jobs in Florida? For Analytical Development Biotech jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Analytical Development Biotech jobs in Florida look for? The top searched job categories for Analytical Development Biotech jobs in Florida are:
What cities in Florida are hiring for Analytical Development Biotech jobs? Cities in Florida with the most Analytical Development Biotech job openings:
Analytical Development Biotech jobs near you
Associate Director, CMC Analytical Development, Separation

Associate Director, CMC Analytical Development, Separation

Syncromune

Fort Lauderdale, FL • On-site, Remote

$165K - $200K/yr

Full-time

Posted 20 days ago

Job description

The Associate 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 5+ 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: $165-$200K
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company's benefit plans.
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