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Cell-based bioassays and potency assays * Microbiology and sterility-related assays * Lead biosimilar characterization programs , including analytical similarity assessments covering: * Primary ...
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PR · On-site
Cell-based bioassays and potency assays * Microbiology and sterility-related assays * Lead biosimilar characterization programs , including analytical similarity assessments covering: * Primary ...
Cell Based Potency Assay information
What are some common challenges faced when developing and validating cell-based potency assays in a laboratory setting?
Developing and validating cell-based potency assays can be challenging due to the inherent biological variability of living cells, which can impact assay reproducibility and consistency. Additionally, optimizing assay conditions—such as cell passage number, incubation times, and reagent quality—requires careful attention to detail. Collaboration across multidisciplinary teams, including scientists, quality control, and regulatory affairs, is often necessary to ensure the assay meets rigorous industry and compliance standards. Successful candidates should be comfortable troubleshooting technical issues and adapting protocols to achieve reliable results.
What are the key skills and qualifications needed to thrive as a Cell Based Potency Assay Scientist, and why are they important?
To excel as a Cell Based Potency Assay Scientist, you need a solid background in cellular biology, assay development, and quantitative analysis, usually supported by a degree in life sciences or a related field. Familiarity with laboratory instruments like flow cytometers, plate readers, and proficiency in data analysis software such as GraphPad Prism are typically required, along with knowledge of GMP/GLP standards. Attention to detail, strong problem-solving abilities, and effective communication skills are essential soft skills in this role. These competencies ensure accurate assay results, regulatory compliance, and clear collaboration with cross-functional teams in biopharmaceutical development.
What are cell based potency assays?
Cell based potency assays are laboratory tests that use living cells to measure the biological activity of a drug, vaccine, or biologic product. These assays help determine how effective a compound is in producing a desired cellular response, making them crucial for drug development and quality control. By closely mimicking the drug’s mechanism of action in the body, they provide more relevant information about efficacy and safety compared to non-cellular assays.
What is the difference between Cell Based Potency Assay vs Cell Culture Technician?
| Aspect | Cell Based Potency Assay | Cell Culture Technician |
|---|---|---|
| Primary Responsibilities | Assessing the biological activity of products using cell-based methods | Maintaining and preparing cell cultures for various experiments |
| Required Skills | Knowledge of assay development, data analysis, cell biology techniques | Cell culture techniques, aseptic handling, media preparation |
| Work Environment | Laboratories focused on assay validation and quality control | Cell culture labs, manufacturing, or research facilities |
| Common Certifications | Biotech or laboratory certifications, cell biology training | Cell culture training, laboratory safety certifications |
While both roles involve working with cells, the Cell Based Potency Assay specialist focuses on developing and performing assays to measure product activity, whereas the Cell Culture Technician primarily prepares and maintains cell cultures. The assay role requires analytical skills and assay-specific knowledge, while the technician role emphasizes cell handling and maintenance skills.
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What job categories do people searching Cell Based Potency Assay jobs in Puerto Rico look for? The top searched job categories for Cell Based Potency Assay jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Cell Based Potency Assay jobs? Cities in Puerto Rico with the most Cell Based Potency Assay job openings:
Full-time
Medical, Dental, Vision
Posted 2 days ago
Job description
Job Title: Senior Leader – Analytical (Tech) Lead
Job Description:
Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.
We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.
Job Overview:
We are seeking an accomplished Senior Leader – Analytical (Tech) Lead to provide strategic and operational leadership across analytical development, technology transfer, and commercial GMP testing for biologics and biosimilars. This role is critical to supporting global regulatory filings, commercial manufacturing, and lifecycle management programs.
The ideal candidate will bring deep expertise in analytical sciences, proven leadership within a reputed CDMO, and extensive experience interacting with global regulatory agencies.
Key Responsibilities:
- Provide strategic leadership for Analytical Sciences across development, tech transfer, validation, and commercial testing activities for biologics, biosimilars, and peptides.
- Lead and oversee analytical method development, qualification, validation, and lifecycle management in a GMP environment.
- Drive technology transfer of analytical methods from development to commercial manufacturing sites, ensuring robustness and regulatory compliance.
- Ensure readiness and support for regulatory inspections and audits by US FDA, EMA, Health Canada, and other global agencies.
- Oversee commercial release and stability testing in compliance with global regulatory expectations.
- Provide technical oversight for advanced analytical techniques, including but not limited to:
- HPLC and related chromatographic methods
- Cell-based bioassays and potency assays
- Microbiology and sterility-related assays
- Lead biosimilar characterization programs, including analytical similarity assessments covering:
- Primary structure (e.g., amino acid sequence, post-translational modifications)
- Secondary structure
- Tertiary and higher-order structure
- Collaborate cross-functionally with Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners.
- Build, mentor, and lead high-performing global analytical teams across diverse cultures and time zones.
- Support global client interactions and act as a scientific and regulatory thought leader for analytical sciences.
Required Qualifications & Experience:
- Bachelor's or Master’s degree in Analytical Chemistry, Biochemistry, Biotechnology, Microbiology, or a related scientific discipline (PhD strongly preferred).
- Minimum 20 years of overall industry experience, with at least 5 years in a top-tier leadership role within a reputed CDMO or biopharmaceutical organization.
- Extensive hands-on and leadership experience in:
- Analytical Development and GMP commercial testing
- Tech transfer for biologics and biosimilars
- Global regulatory submissions and post-approval support
- Proven exposure to and successful management of US FDA, EMA, Health Canada, and other global regulatory inspections.
- Strong technical expertise in HPLC, cell-based assays, and microbiological assays.
- Demonstrated experience with biosimilar analytical characterization and similarity assessment is highly desirable.
- Deep understanding of ICH, FDA, EMA, and global regulatory guidelines relevant to analytical sciences.
- Excellent leadership, communication, and stakeholder management skills.
- Ability and willingness to relocate to Aguadilla, Puerto Rico, and work full-time on site.
- Proven ability to operate effectively across multicultural teams and multiple time zones.
What we offer:
- Competitive salary (DOE.)
- Health, dental, and vision benefits.
- Professional training and development opportunities.
- Opportunities to participate in the company stock options program
We Are an Equal Opportunity Employer
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you want to challenge yourself, accelerate your career, and give new hope to patients, there is no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
To learn more about us, please visit our website: https://ocyonbio.com