Chemist II, Bioanalytics
Boca Raton, FL · On-site
Job Title: Chemist II, Bioanalytics Position Summary The Chemist II, Bioanalytics will perform ... Use technical and scientific knowledge to recommend solutions to problems as directed by QC ...
Chemist II, Bioanalytics
Boca Raton, FL · On-site
Job Title: Chemist II, Bioanalytics Position Summary The Chemist II, Bioanalytics will perform ... Use technical and scientific knowledge to recommend solutions to problems as directed by QC ...
The Andrologist reports directly to the laboratory director and is responsible for communicating ... Bioanalysis (AAB) or equivalent as a Medical Technologist (MT)
The Andrologist reports directly to the laboratory director and is responsible for communicating ... Bioanalysis (AAB) or equivalent as a Medical Technologist (MT)
The Andrologist reports directly to the laboratory director and is responsible for communicating ... Bioanalysis (AAB) or equivalent as a Medical Technologist (MT)
The Andrologist reports directly to the laboratory director and is responsible for communicating ... Bioanalysis (AAB) or equivalent as a Medical Technologist (MT)
Bioanalysis Director information
What are the key skills and qualifications needed to thrive as a Bioanalysis Director, and why are they important?
A Bioanalysis Director should possess an advanced degree in life sciences, extensive experience in bioanalytical method development, and a strong understanding of regulatory guidelines such as GLP and GCP. Familiarity with analytical instruments like LC-MS/MS, LIMS, and relevant certifications (e.g., ASCP or equivalent) are commonly required. Strong leadership, project management, and communication skills are essential for coordinating teams and collaborating with stakeholders. These competencies ensure scientific rigor, regulatory compliance, and efficient delivery of high-quality data in bioanalytical studies.
What are some common challenges faced by a Bioanalysis Director when leading cross-functional teams in pharmaceutical research?
A Bioanalysis Director often encounters challenges related to coordinating efforts across multidisciplinary teams, such as scientists, project managers, and regulatory specialists. Ensuring clear communication, alignment on project timelines, and compliance with regulatory standards can be complex, especially in fast-paced environments. Additionally, balancing resource allocation and adapting to shifting scientific priorities requires strong leadership and strategic planning. Overcoming these challenges is key to delivering high-quality analytical data that supports drug development milestones.
What does a Bioanalysis Director do?
A Bioanalysis Director oversees the design, implementation, and management of bioanalytical studies, typically within pharmaceutical or biotechnology organizations. They ensure that laboratory operations comply with regulatory standards and that analytical methods for measuring drugs, metabolites, or biomarkers are validated and reliable. Responsibilities also include managing scientific teams, coordinating with other departments, and representing bioanalytical interests in project meetings. Ultimately, they play a key role in ensuring the integrity and quality of data used in drug development.
What is the difference between Bioanalysis Director vs Bioanalytical Scientist?
| Aspect | Bioanalysis Director | Bioanalytical Scientist |
|---|---|---|
| Required credentials | Advanced degree (PhD or MS), leadership experience | Bachelor's or Master's in life sciences, specialized training |
| Work environment | Management, strategic planning, overseeing teams | Laboratory research, method development, data analysis |
| Employer usage | Pharmaceutical, biotech companies, CROs | Research labs, biotech firms, CROs |
| Search intent | Leadership roles, management, strategic oversight | Technical skills, laboratory work, data generation |
The Bioanalysis Director typically oversees the entire bioanalytical department, focusing on strategy and management, while the Bioanalytical Scientist conducts hands-on laboratory research and method development. Both roles are essential in the bioanalysis field but differ in responsibilities and seniority.
What are popular job titles related to Bioanalysis Director jobs in Florida? For Bioanalysis Director jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Bioanalysis Director jobs in Florida look for? The top searched job categories for Bioanalysis Director jobs in Florida are:
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
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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 Chemist II, Bioanalytics in Boca Raton, FL!
Job Title: Chemist II, Bioanalytics
Job Description:
Position Summary
The Chemist II, Bioanalytics will perform quality control testing of raw materials, in-process, and final products with minimal supervision, with a concentration in immunoassays. Uses knowledge of corporate policies to resolve routine problems and ensure compliance with procedures.
Essential Functions (ES) and Responsibilities
Job Responsibilities or Job Requirements
Competencies
Ability to follow the cGMP's and procedures with great attention to detail
Able to work in high-pressure, deadline-driven environment
Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines
Possess time management skills and be able to balance multiple job assignments at once
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
Experience Requirements
Education Requirements: Bachelor's degree in Chemistry, Biochemistry, Molecular Biology, or related science discipline.
Experience Requirements: At least three years of experience performing chemical/biochemical testing or developing immunoassays. Work in a regulated environment (FDA, EPA, etc.) is highly preferred.
Preferred Experience
Compliance Requirements (ES)
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
Job Description Footer:
In addition to competitive compensation, we offer a comprehensive benefits package including:
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.
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 Chemist II, Bioanalytics in Boca Raton, FL!
Job Title: Chemist II, Bioanalytics
Job Description:
Position Summary
The Chemist II, Bioanalytics will perform quality control testing of raw materials, in-process, and final products with minimal supervision, with a concentration in immunoassays. Uses knowledge of corporate policies to resolve routine problems and ensure compliance with procedures.
Essential Functions (ES) and Responsibilities
- Perform quality control testing for raw materials, in-process, and final product samples, according to approved Standard Operating Procedures (SOPs) and cGMP guidelines
- Complete testing documentation and data entry as required for procedures and tests performed
- Apply knowledge of analyzing issues and uses judgment to make decisions
- Knowledge of immunoassays, specifically plate-based assays and ELISAs
- Utilize cGMP practices in documentation and execution of job functions
- Perform instrument calibration or qualification according to written procedures
- Write and revise SOPs and/or participate in validation protocol execution, as needed
- Perform testing, as needed, to generate data for qualification/validation and special projects
- Fulfill requests from management for assistance in other matters, as needed
- Accountable for following SOPs and adhering to cGMP guidelines
- Review documentation on trained tasks as assigned by QC management
- Use technical and scientific knowledge to recommend solutions to problems as directed by QC management
- Mentor junior analysts and provide training as requested on QC assays.
Job Responsibilities or Job Requirements
Competencies
Ability to follow the cGMP's and procedures with great attention to detail
Able to work in high-pressure, deadline-driven environment
Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines
Possess time management skills and be able to balance multiple job assignments at once
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
Experience Requirements
Education Requirements: Bachelor's degree in Chemistry, Biochemistry, Molecular Biology, or related science discipline.
Experience Requirements: At least three years of experience performing chemical/biochemical testing or developing immunoassays. Work in a regulated environment (FDA, EPA, etc.) is highly preferred.
Preferred Experience
Compliance Requirements (ES)
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
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-Rail
- Company paid 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.