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Bioanalytical Project Manager Jobs in Florida (NOW HIRING)

Bioanalytical Project Manager information

What are the key skills and qualifications needed to thrive as a Bioanalytical Project Manager, and why are they important?

To thrive as a Bioanalytical Project Manager, you need a strong background in bioanalysis, project management experience, and typically a degree in life sciences or a related field. Familiarity with laboratory information management systems (LIMS), regulatory guidelines (such as GLP/GCP), and project management tools like MS Project is essential. Excellent communication, leadership, and organizational skills help manage cross-functional teams and client expectations. These skills ensure the successful planning, execution, and delivery of complex bioanalytical projects within regulatory and timeline constraints.

What are some common challenges faced by Bioanalytical Project Managers, and how can they be addressed?

Bioanalytical Project Managers often face challenges coordinating timelines across multiple stakeholders, such as laboratory teams, clients, and regulatory bodies. Managing shifting project priorities and ensuring data integrity under tight deadlines can also be demanding. To address these challenges, effective communication, proactive risk management, and strong organizational skills are essential. Regular status meetings, clear documentation, and building strong relationships with both internal and external partners help keep projects on track and ensure compliance with regulatory standards.

What does a Bioanalytical Project Manager do?

A Bioanalytical Project Manager oversees and coordinates bioanalytical studies, ensuring that projects are completed on time, within budget, and according to regulatory standards. They act as the main point of contact between clients, laboratory teams, and regulatory agencies, managing study timelines, resources, and data quality. Their responsibilities include planning project activities, monitoring progress, troubleshooting issues, and reporting results to stakeholders. They play a critical role in drug development by ensuring that bioanalytical testing meets scientific and compliance requirements.

What is the difference between Bioanalytical Project Manager vs Bioanalytical Scientist?

AspectBioanalytical Project ManagerBioanalytical Scientist
CredentialsBachelor's or Master's in Life Sciences, PMP often preferredDegree in Biology, Chemistry, or related field; PhD or Master's common
Work EnvironmentProject teams, client meetings, coordination rolesLaboratory research, data analysis, method development
Employer & Industry UsagePharmaceutical, biotech companies, CROsResearch labs, pharmaceutical companies, CROs

The Bioanalytical Project Manager oversees project timelines, budgets, and client communication, ensuring successful completion. In contrast, the Bioanalytical Scientist focuses on experimental design, data collection, and method development. Both roles are essential in the bioanalytical industry but differ in responsibilities and daily tasks.

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Chemist II, Bioanalytics

ADMA BIOMANUFACTURING LLC

Boca Raton, FL • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired today. Applications are no longer accepted.


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
  • 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.