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Fda Scientist Jobs in Puerto Rico (NOW HIRING)

Sr Sterility Assurance Scientist

Anasco, PR

$89K - $122K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

SUMMARY DESCRIPTION The Sterility Assurance Scientist is responsible for supporting activities that ... Obtains and maintains knowledge of FDA, ISO, and EN sterilization and related microbiology ...

PR · On-site

  • Medical

  • Dental

  • Vision

Understanding of FDA cGMP regulations, ICH guidelines, and industry best practices related to tech transfer and manufacturing sciences. Skills * Strong analytical and problem-solving skills. * Strong ...

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical ...

PR · On-site

  • Medical

  • Dental

  • Vision

Deep understanding of ICH, FDA, EMA, and global regulatory guidelines relevant to analytical sciences. * Excellent leadership, communication, and stakeholder management skills. * Ability and ...

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical ...

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical ...

PR · On-site

Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA, etc). 18 ... Technical and scientific capability to make firm decisions and recommendations * Excellent ...

PR · On-site

We are committed to compliance with FDA, EMA, and ICH requirements and to fostering a strong ... scientific discipline (Master's degree preferred). · Minimum 5 years of experience in ...

PR · On-site

Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal ... Bachelor's Degree in Engineering, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life ...

PR · On-site

Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal ... Bachelor's Degree in Engineering, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life ...

PR · On-site

Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal ... Bachelor's Degree in Engineering, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life ...

PR · On-site

Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal ... Bachelor's Degree in Engineering, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life ...

PR · On-site

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline. * Strong understanding of: * cGMP regulations * FDA validation requirements * ISPE Baseline ...

PR · On-site

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline. * Strong understanding of: * cGMP regulations * FDA validation requirements * ISPE Baseline ...

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Showing results 1-20

Fda Scientist information

What is an FDA Scientist?

An FDA Scientist is a researcher or regulatory expert responsible for evaluating the safety, efficacy, and quality of pharmaceutical drugs, medical devices, biologics, and food products. They conduct laboratory research, review clinical trial data, and assess regulatory submissions to ensure compliance with federal laws and guidelines. FDA Scientists play a critical role in protecting public health by making science-based decisions on product approvals and safety standards.

What types of projects and responsibilities can I expect as an FDA Scientist?

As an FDA Scientist, you'll typically be involved in reviewing data from clinical trials, conducting laboratory research, evaluating the safety and efficacy of pharmaceuticals or medical devices, and preparing reports for regulatory submissions. You'll collaborate closely with multidisciplinary teams including chemists, statisticians, and regulatory specialists to ensure scientific rigor and adherence to federal standards. Some days may involve detailed data analysis, while others could require participating in cross-team meetings or interacting with external stakeholders. This dynamic environment offers opportunities to contribute to important public health decisions and develop specialized expertise over time.

What are the key skills and qualifications needed to thrive in the FDA Scientist position, and why are they important?

To thrive as an FDA Scientist, you need a solid background in biology, chemistry, pharmacology, or a related scientific field, typically supported by at least a bachelor's or advanced degree. Familiarity with regulatory submission systems, laboratory information management systems (LIMS), and relevant certifications such as Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) is important. Strong analytical thinking, attention to detail, and effective communication skills help you excel when collaborating with colleagues and presenting findings. These abilities ensure accurate data review and regulatory compliance, which are crucial for advancing public health and safety.

How much do FDA scientists make?

FDA scientists typically earn between $70,000 and $130,000 annually, depending on experience, education, and location. Entry-level positions often start around $70,000, while experienced scientists with advanced degrees can earn higher salaries, especially in supervisory or specialized roles.

What are popular job titles related to Fda Scientist jobs in Puerto Rico?

For Fda Scientist jobs in Puerto Rico, the most frequently searched job titles are:

What job categories do people searching Fda Scientist jobs in Puerto Rico look for?

The top searched job categories for Fda Scientist jobs in Puerto Rico are:

Infographic showing various Fda Scientist job openings in Puerto Rico as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 15% Part Time, 3% Contract, and 1% Nights. Highlights an 90% Physical, 2% Hybrid, and 8% Remote job distribution.

Manufacturing & Technology - Principal Scientist

FITS LLC

Manati, PR • On-site

$120 - $180/hr

Other

Re-posted 9 days ago


Job description

Principal Scientist

What Makes You a Fit:

The Technical Part:

  • Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline and five plus (5+) years of experience in the pharmaceutical or biotechnology industry.
  • Shift: Administrative and according to business needs.
  • Billingual (Spanish & English)
  • Experience in:
    • Experience supporting Manufacturing Science & Technology (MS&T), Process Sciences, Technical Services, or Technical Transfer.
    • Strong knowledge of sterile manufacturing processes.
    • Experience with liquid and/or lyophilized parenteral manufacturing.
    • Knowledge of process validation and technology transfer activities.
    • Experience writing and reviewing technical documentation.
    • Understanding of cGMP regulations and FDA requirements.

The Personality Part:

  • Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail that nothing gets past you. If this sounds like you, and if you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

As a Piece of Fits, you will: (The day-to-day on the job)

  • Support sterile commercial manufacturing operations for liquid and lyophilized parenteral products.
  • Provide technical support for the technology transfer of Nulojix and Reblozyl.
  • Assist the Site Subject Matter Expert for formulation, filling, and lyophilization processes.
  • Develop project plans and support execution of technical transfer activities.
  • Design, develop, and execute experimental, characterization, and validation protocols.
  • Support process validation and process performance activities.
  • Coordinate cross-functional activities to ensure successful technology transfer execution.
  • Participate as a core member of Technical Transfer and New Product Introduction (NPI) teams.
  • Support manufacturing studies including: Mixing Studies, Filling Studies, Lyophilization Studies, Capping Studies, Washer & Tunnel Performance Qualification (PQ).
  • Prepare, review, verify, and support technical documentation including: Technical Transfer Documents, Validation Plans, Mixing Study Reports, Excipient Holding Time Studies, Drug Product Holding Time Studies, Filling Machinability Studies, Lyophilization Studies, Capping Machinability Studies.
  • Participate in project meetings and provide technical recommendations.

Being a Fits Piece Comes with Perks:

  • Competitive compensation, benefits, and opportunities for professional growth.

Who We Are:

We are a Service Provider company that supports the Pharmaceutical, Medical Device, and Manufacturing industries in the US and the US islands, offering engineering, construction, maintenance, utilities, and specialized technical services. We prioritize the well-being of our employees and strive to deliver high-quality talent to our clients.

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, or disability.

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