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Associate Downstream Process Development Scientist Jobs in Florida

AIS, Inc.

Data Scientist

Miami, FL · On-site

... downstream analytical and AI/ML applications * Maintain familiarity with diverse data types and ... data processing efficiency * Support annotation of datasets and development of machine learning ...

Radiance Technologies

Radiance is seeking a highly qualified and motivated scientist to support Geospatial Intelligence ... Perform algorithm development for complex data exploitation processes Required Skills and ...

Adecco

Process Engineer

Sarasota, FL

$40 - $45/hr

Experience with process development, DOE, PFMEA, and process validation activities. * Proficiency ... In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other ...

Adecco

Process Engineer

Sarasota, FL

$40 - $45/hr

Experience with process development, DOE, PFMEA, and process validation activities. * Proficiency ... In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other ...

Adecco

Process Engineer

Sarasota, FL

$40 - $45/hr

Experience with process development, DOE, PFMEA, and process validation activities. * Proficiency ... In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other ...

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Associate Downstream Process Development Scientist information

What is an Associate Downstream Process Development Scientist?

An Associate Downstream Process Development Scientist is a professional who works in the biotechnology or pharmaceutical industry, focusing on developing and optimizing processes that purify biological products, such as proteins or antibodies, after they have been produced by cells. Their work is crucial for ensuring the final product meets quality and safety standards before it is used in research or clinical applications. They typically perform laboratory experiments, analyze data, and collaborate with other scientists and engineers to improve yield and efficiency. This role is often entry-level or early-career, providing hands-on experience in process development and technical troubleshooting.

What are the key skills and qualifications needed to thrive as an Associate Downstream Process Development Scientist, and why are they important?

To excel as an Associate Downstream Process Development Scientist, you need a solid understanding of biochemistry, chemical engineering, and downstream purification techniques, often supported by a bachelor's or master's degree in a life science or engineering discipline. Familiarity with chromatographic systems (such as AKTA), filtration equipment, and analytical tools, as well as knowledge of GMP/GLP regulations, is typically required. Strong problem-solving, attention to detail, and effective teamwork and communication skills help you navigate complex experiments and collaborate with cross-functional teams. These skills ensure efficient process optimization, compliance with regulatory standards, and successful development of biopharmaceutical products.

What is the difference between Associate Downstream Process Development Scientist vs Associate Upstream Process Development Scientist?

AspectAssociate Downstream Process Development ScientistAssociate Upstream Process Development Scientist
Primary FocusPurification and recovery of bioproductsCell culture and fermentation processes
Required SkillsProtein purification, chromatography, filtrationCell culture, bioreactor operation, media preparation
Work EnvironmentLaboratories, manufacturing facilitiesLaboratories, bioreactor labs
Common CertificationsBiotech or bioprocessing certificationsBiotech or bioprocessing certifications

Both roles are essential in biopharmaceutical development, focusing on different stages of the production process. The Associate Downstream Process Development Scientist specializes in purification techniques, while the Associate Upstream Process Development Scientist concentrates on cell growth and fermentation. Understanding these distinctions helps candidates target their skills and career paths effectively.

What are some typical challenges faced by an Associate Downstream Process Development Scientist, and how can they be addressed?

Associate Downstream Process Development Scientists often encounter challenges such as optimizing purification processes, troubleshooting equipment performance, and ensuring batch-to-batch consistency. These challenges can be addressed by maintaining meticulous documentation, collaborating closely with upstream and analytical teams, and staying current with best practices in chromatography and filtration. Proactively seeking feedback from experienced colleagues and participating in cross-functional meetings can also help in identifying solutions and improving process efficiency.
What are the most commonly searched types of Downstream Process Development Scientist jobs in Florida? The most popular types of Downstream Process Development Scientist jobs in Florida are:
What cities in Florida are hiring for Associate Downstream Process Development Scientist jobs? Cities in Florida with the most Associate Downstream Process Development Scientist job openings:
Associate Downstream Process Development Scientist 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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