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Assay Development Manager Jobs in Florida (NOW HIRING)

VIVEX BIOLOGICS INC

Research Scientist

Miami, FL · On-site

This role contributes to the development and evaluation of tissue allografts through experimental ... Strong organizational skills with the ability to manage multiple projects, timelines, and ...

New

VIVEX BIOLOGICS INC

Research Scientist

Miami, FL

This role contributes to the development and evaluation of tissue allografts through experimental ... Strong organizational skills with the ability to manage multiple projects, timelines, and ...

New

University of Miami

Research Associate 1

Miami, FL

... and developments within the area of research. 6. Collects, prepares, analyzes, dissects, and ... Conduct nucleic acid amplification assays (PCR, RT-qPCR). * Biochemistry & Protein Analysis:Execute ...

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Assay Development Manager information

What are the key skills and qualifications needed to thrive as an Assay Development Manager, and why are they important?

To thrive as an Assay Development Manager, you need a strong background in molecular biology, biochemistry, or a related field, typically with an advanced degree and experience in assay design and validation. Familiarity with laboratory automation, data analysis software, and quality management systems is essential, along with relevant certifications like GLP or ISO standards. Strong project management, leadership, and communication skills help drive cross-functional teams and ensure effective collaboration. These competencies are crucial for delivering reliable assays that meet scientific, regulatory, and business objectives.

What are some common challenges faced by an Assay Development Manager during the early stages of a new project?

One of the main challenges Assay Development Managers encounter in the early phases of a project is balancing the need for high sensitivity and specificity with practicality and scalability. They often need to troubleshoot unexpected assay variability, optimize protocols, and ensure the reproducibility of results under tight deadlines. Additionally, coordinating input from cross-functional teams—such as R&D scientists, quality assurance, and regulatory affairs—can present logistical hurdles. Effective communication and project management skills are essential to navigate these complexities and drive the project forward.

What is an Assay Development Manager?

An Assay Development Manager is a scientific professional responsible for leading the design, development, validation, and optimization of laboratory assays, which are tests used to measure the presence or amount of a substance in biological samples. They manage teams of scientists and collaborate closely with research, quality, and regulatory departments to ensure assays meet scientific and regulatory requirements. Their work is vital in fields such as biotechnology, pharmaceuticals, and diagnostics, supporting drug discovery, disease diagnosis, and product development.

What is the difference between Assay Development Manager vs Laboratory Supervisor?

AspectAssay Development ManagerLaboratory Supervisor
CredentialsBachelor's/Master's in Life Sciences, relevant certificationsBachelor's in Life Sciences or related field, relevant certifications
Work EnvironmentResearch labs, biotech or pharma companiesLaboratories, clinical or research settings
Employer & IndustryBiotech, pharmaceutical, diagnosticsResearch institutions, hospitals, biotech
Primary FocusDesigning and optimizing assays, project managementOverseeing daily lab operations, staff supervision

The Assay Development Manager focuses on designing, developing, and optimizing assays, often managing projects and teams. In contrast, the Laboratory Supervisor oversees daily lab operations and staff, ensuring smooth workflow. Both roles require relevant scientific credentials and work in similar environments, but their core responsibilities differ significantly.

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What job categories do people searching Assay Development Manager jobs in Florida look for? The top searched job categories for Assay Development Manager jobs in Florida are:
What cities in Florida are hiring for Assay Development Manager jobs? Cities in Florida with the most Assay Development Manager job openings:
Assay Development Manager jobs near you

Senior Scientist, Analytical Development

ADMA BIOMANUFACTURING LLC

Boca Raton, FL • On-site

$85.10K - $116.20K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 16 days ago

Job description

Job Description Header:
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Scientist, Analytical Development.
Job Title: Senior Scientist, Analytical Development
Job Description:
Position Summary
Demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. Works on complex problems in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Essential Functions (ES) and Responsibilities
  • Develop, qualify, validate Bioassays with minimum supervision, write SOPs and transfer methods to QC department as needed.
  • Be familiar with regulatory guidelines pertaining to assay development/qualification/validation.
  • Be familiar with BSL-2 laboratories and working in BSL-2 environment
  • Design experiments and write protocols for assay development and validation.
  • Perform assays or supervise other analysts for assay development and validation work.
  • Frequently write technical reports and present findings to internal or external clients.
  • Analyze experimental data with appropriate statistical tools and report scientific results.
  • Interpret data and adhere to strict guidelines on documentation when recording data.
  • Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary.
  • Analyze samples from various sources to provide information on compounds or quantities of compounds present. Use of mammalian cell culture techniques
  • Use analytical technique, software,, and instrumentation, such as HPLC, GC, spectrophotometric assays, immunochemical methods, titration assays, SDS PAGE, IEF, ELISAs, enzymatic assays and/or IR spectroscopy

Job Responsibilities or Job Requirements
Competencies
Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines
Possesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendations
Possesses strong organizational, critical thinking, reasoning, and problem-solving abilities.
Experience Requirements
  • Education Requirements: Masters or PhD in a scientific discipline such as Chemistry, Analytical Chemistry, Biochemistry, Biological Sciences, Engineering or equivalent is required.
  • Experience Requirements: Minimum 5 years of industrial experience. Expert knowledge of scientific principles and concepts. Extensive experience with chemical/biochemical and biological testing is necessary. The individual should have experience with one or more of the following: mammalian cell culture techniques, Bioassay development, neutralization assays, method transfer, Bioassay development and validation. Knowledge of working in a BSL-2 environment and be familiar with required guidelines and procedures.
  • Physical Requirements (ES):
  • Working under BSL-2 conditions, exposure to infectious materials (human source products), toxic chemicals, chemical fumes and odors, electrical hazards, temperature extremes when going to and from coolers and freezers.
  • Stressors: Maintain work flow. Assuring high quality product, within ADMA's SOPs and other guidelines at all times.
  • Physical Demands: Must walk, sit, stand, carry, lift and pull; some close sight required. Exposure to human source products, odors, and sudden temperature changes under normal laboratory conditions.
  • Physical Location of Role: Boca Raton, FL

Preferred Experience
  • Work collaboratively in cross-functional teams. Interact with contract labs in method development/qualification/validation.
  • Be aware of and keep up to date with health and safety issues in all aspects of the work undertaken.
  • Use judgment, creativity and sound technical knowledge to obtain and recommend solutions to problems as directed by AD management.
  • Maintain an overview of current QC methods and propose areas for improvement.
  • Maintain current knowledge in field of expertise through reading articles and attending technical courses.

Compliance Requirements (ES)
Job Description Footer:
In addition to competitive compensation, we offer a comprehensive benefits package including:
  • 401K plan with employer match and immediate vesting
  • Medical, Vision, Life and Dental Insurance
  • Pet Insurance
  • Company paid STD and LTD
  • Company Paid Holidays
  • 3 Weeks' Paid Time Off (within the first year)
  • Tuition Assistance (after the first year)
  • Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer.

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