Proficiency in Mass Spectroscopy and peptide testing is essential, with experience in bioassay ... results to manager/Director. * Maintaining full compliance with all applicable US FDA - cGMP ...
Proficiency in Mass Spectroscopy and peptide testing is essential, with experience in bioassay ... results to manager/Director. * Maintaining full compliance with all applicable US FDA - cGMP ...
Director Bioassay Scientist information
What are the key skills and qualifications needed to thrive as a Director Bioassay Scientist, and why are they important?
To thrive as a Director Bioassay Scientist, you need an advanced degree (PhD or equivalent) in biology, biochemistry, or a related field, along with extensive experience in assay development and validation. Expertise in technologies such as ELISA, cell-based assays, flow cytometry, and regulatory compliance systems like GLP or GMP is typically required. Strong leadership, project management, and cross-functional communication skills help drive team success and ensure alignment with organizational goals. These competencies are crucial for ensuring scientific rigor, regulatory compliance, and successful delivery of bioanalytical programs in a dynamic biotech environment.
What are some typical challenges a Director Bioassay Scientist faces when leading cross-functional teams in assay development projects?
A Director Bioassay Scientist often navigates challenges such as aligning diverse scientific perspectives, managing tight project timelines, and ensuring clear communication between departments like research, regulatory, and quality assurance. Balancing innovation with regulatory compliance is also critical, as is mentoring team members while driving projects forward. Success in this role requires strong leadership, adaptability, and the ability to foster collaboration across multidisciplinary teams to achieve shared goals.
What does a Director Bioassay Scientist do?
A Director Bioassay Scientist leads the development, validation, and implementation of bioassays to assess the potency, safety, and efficacy of biological products in pharmaceutical or biotechnology companies. This role includes overseeing laboratory teams, ensuring regulatory compliance, and collaborating with other departments such as quality assurance, regulatory affairs, and process development. The director is responsible for strategic planning, resource management, and staying current with advancements in assay technologies. They also play a key role in interpreting bioassay data and supporting submissions to regulatory agencies.
What is a bioassay specialist?
A bioassay specialist is a professional who designs, conducts, and analyzes biological tests to measure the potency, safety, or efficacy of pharmaceuticals, vaccines, or biological products. They often work in laboratory settings, utilizing techniques such as cell culture and assay development, and may require knowledge of regulatory standards and quality control processes.
What is the difference between Director Bioassay Scientist vs Senior Bioassay Scientist?
| Aspect | Director Bioassay Scientist | Senior Bioassay Scientist |
|---|---|---|
| Credentials | Typically requires a PhD or Master’s in biology, immunology, or related field; extensive experience in bioassay development | Usually requires a Master’s or PhD; significant experience in bioassay techniques |
| Work Environment | Leads teams, manages projects, and collaborates with cross-functional departments | Performs hands-on bioassay work, data analysis, and method validation |
| Employer & Industry | Found in biotech, pharmaceutical, and contract research organizations | Commonly employed in similar settings, often within R&D departments |
The main difference is that the Director Bioassay Scientist oversees teams and projects, focusing on strategic leadership, while the Senior Bioassay Scientist primarily conducts technical work and method development. Both roles require advanced credentials and industry experience, but the director position involves more managerial responsibilities.
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Job description
Description
Job Summary:
Granules Pharmaceuticals, Inc., is seeking a detail-oriented and scientifically driven Sr. Scientist to join our team in the area of Analytical Method Development and Validation. The ideal candidate will possess strong expertise in developing and validating analytical methods for assay, related compounds, residual solvents, dissolution, and particle size analysis. Proficiency in Mass Spectroscopy and peptide testing is essential, with experience in bioassay methodologies considered a plus. This role requires a solid understanding of scientific principles to troubleshoot and solve analytical challenges, as well as experience in drafting and reviewing method validation protocols and reports in compliance with SOPs and regulatory guidelines. Strong communication skills and the ability to interpret technical procedures, FDA guidance documents, and scientific literature are essential for success in this role.
JOB DUTIES & RESPONSIBILITIES include but not limited to:
- With minimal supervision, perform the analytical method development and method validation for dissolution, assay, and related compounds of raw material and finished products.
- Develops and validates methods to determine purity, potency, identity, residuals, and characterization of peptide products.
- Ability to individually work on development and validation for Reversed-Phase, Ion Exchange, and Size Exclusion chromatography using UPLC/HPLC/MS.
- Draft the analytical method validation protocols and reports
- Performs testing pharmaceutical raw materials, bulk and finished products, scale-up samples, process validation samples, cleaning verification/validation samples, and stability samples to support formulation development.
- Responsible for the timely and accurate execution of lab analysis.
- Independently compile the analytical data, make sound judgment of the data and interpret the data, and notify the results to manager/Director.
- Maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs.
- Maintain laboratory notebooks and records of all the raw data as per Good Documentation Practices.
- Assists with training other junior members of the analytical development team as needed
- Maintain individual training records.
- Follow safety procedures and practices.
- Maintain a clean, orderly work environment.
- Works with computer-controlled equipment and processes.
- Performs other work-related duties as assigned
- Perform in-vitro dissolution testing for in-process, finished product and stability samples.
- Execute method transfer activities for raw materials and finished dosage forms.
- Ensures compliance with SOPs, policies and procedures required by the Company and regulatory agencies.
- Document experiments accurately and complete all associated documents (Instrument, Standard and Column usage logbooks) in compliance with internal SOPs and FDA guidelines.
- Evaluate test results against standards and timely reporting of any deviations, OOS, OOT and atypical results to the supervisor/department head.
- Other duties assigned by management based on requirements.
- Management Responsibility
- Assign daily work schedule in timely manner
- Provide Suggestions in method Development and validation.
- Interpret and review generated results
- Provide assistance in professional development.
Reports to:
Manager Analytical R&D
Requirements
Knowledge & Skills:
- Hands-on experience in Dissolution, HPLC, LC-MSGC, UV, FTIR, and other laboratory instruments.
- Experience with a wide variety of software and information systems (e.g. Empower, Microsoft word and Excel).
- Strong knowledge in analytical method development and validation under cGMP environment and experience in problem-solving skills and instrument troubleshooting.
- Good oral and written communication skills and the ability to write and review technical report
- Proven Knowledge of the major analytical techniques and operation of instruments such as HPLC, GC, dissolution, FT-IR, UV-VIS Spectrophotometer, Particle size analysis (Malvern Mastersizer, Sonic sifting and Sieve shaker), Karl Fisher Instrument, Potentiometric Titration, Density meter, pH meter, Melting point apparatus, Analytical Balances, Viscometer
- Proficient in documentation as per Good Documentation Practice
- Computer skills including Microsoft and Excel
- Excellent verbal and written communication and skills
Experience & Education:
- Bachelor's degree in Analytical Chemistry or Chemistry or related field with 4+ years or MS/PhD with 2+ years of GMP and GLP-related pharmaceutical industry experience in Peptide and small molecule solid oral formulation analytical development.
- Knowledge of Good Manufacturing Practices (cGMP)
- Experience with software and information systems (e.g. Empower, Microsoft word and Excel)
- Physical Requirements/Working Environment
- Must be able to stand for long periods of time (up to 12-hour shifts), maneuver at least 40 pounds, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE.
- Vision - ability to see details at close range (within a few feet of the observer).
Physical Requirements/Working Environment:
- Must be able to stand for long periods of time (up to 12-hour shifts), maneuver at least 40 pounds, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE.
- Vision - ability to see details at close range (within a few feet of the observer).
Disclaimer:
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.