BioSpace
Job Title
AR&D Scientist III – TEMP
Company Tris Pharma, Inc.
Summary The AR&D Scientist III, under guidance, performs laboratory analyses of raw materials, in process (IP), finished product (FP) and stability (ST) samples, as well as maintenance and calibration of analytical instruments. The incumbent also executes physical characterization studies to facilitate product understanding and performs technical and specialized analytical tasks, conducts research on assigned problems and studies to support product development, method development and technical investigations. She/he supports laboratory investigations and performance of non‑routine testing such as method comparisons and evaluations. The incumbent also assists and trains lower‑level scientists.
Essential Functions
Carries out responsibilities in accordance with company policies, SOPs, and laws.
Sets up and operates analytical instruments (HPLC, GC, UV/Vis, IR, TLC, automatic titration, ICP‑MS, dissolution apparatus, etc.) to support sample testing.
Performs all laboratory analyses of raw materials, IP, FP and ST samples; prepares standard and sample solutions as required by the test methods.
Performs wet chemistry tests such as Limit of Detection (LOD), pH and titration.
Performs physical tests and studies (particle size, viscosity, density, rheological measurements, microscopies and thermal analysis).
Performs all necessary calculations associated with test analyses.
Designs and executes pre‑formulation studies (pH solubility, pH stability and excipients compatibility studies) in collaboration with PD.
Executes designed studies to support laboratory investigations.
Performs non‑routine testing such as method comparisons and evaluations.
Documents all testing details and results in laboratory notebooks compliant with cGDPs.
Assists and trains lower‑level scientists.
Creates and reviews ARD SOPs as needed.
Cleans, maintains and calibrates laboratory instruments to ensure compliance with cGLPs and cGMPs.
Cleans and organizes ARD lab areas.
Performs related duties as assigned.
Qualifications
Bachelor’s degree in Chemistry or related science field and minimum 8 years’ experience in analytical/method development or method validation in the pharmaceutical or biotechnology field.
OR Master’s degree in Chemistry or related science field and minimum 5 years’ experience in analytical/method development or method validation.
OR PhD in Chemistry or related science field with 1‑3 years’ experience in analytical/method development or method validation in the pharmaceutical, biotechnology and/or academic research field.
Knowledge‑Skills‑Abilities
Understanding of spectroscopic and chromatographic techniques and concepts.
Hands‑on experience in setting up and operating multiple analytical instrumentation (HPLC, UV/Vis, GC, TLC, ICP‑MS and dissolution apparatus).
Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements.
Ability to perform analytical testing, calculations and data analysis.
Ability to perform wet chemistry and physical characterization studies.
Ability to train and mentor lower‑level scientist.
Proficiency with Microsoft Office.
Ability to work independently and collaboratively in a fast‑paced, matrixed, team environment.
Analytical thinking with problem‑solving skills and the ability to adapt to changing priorities and deadlines.
Planning, organization and time‑management skills including the ability to support and prioritize multiple projects.
Fluent in English (verbal and written).
Preferred
Proficiency with Empower software.
Travel Requirements 0%
Physical Requirements
Laboratory based position.
Ability to lift up to 30 lbs.
Ability to use Personal Protective Equipment (PPE).
Ability to stand for extended periods of time.
Compensation Pay rate for temp – $45‑55 per hour. Anticipated salary range for permanent employee – $95k to $115k.
Benefits
Medical, dental, vision, Rx insurance.
401K with match.
Life insurance.
Paid Company Holidays.
PTO.
Paid Volunteer Time.
Employee Resource Groups.
Equal Opportunity Employer Tris Pharma, Inc. is an Equal Opportunity Employer.
#J-18808-Ljbffr
Company Tris Pharma, Inc.
Summary The AR&D Scientist III, under guidance, performs laboratory analyses of raw materials, in process (IP), finished product (FP) and stability (ST) samples, as well as maintenance and calibration of analytical instruments. The incumbent also executes physical characterization studies to facilitate product understanding and performs technical and specialized analytical tasks, conducts research on assigned problems and studies to support product development, method development and technical investigations. She/he supports laboratory investigations and performance of non‑routine testing such as method comparisons and evaluations. The incumbent also assists and trains lower‑level scientists.
Essential Functions
Carries out responsibilities in accordance with company policies, SOPs, and laws.
Sets up and operates analytical instruments (HPLC, GC, UV/Vis, IR, TLC, automatic titration, ICP‑MS, dissolution apparatus, etc.) to support sample testing.
Performs all laboratory analyses of raw materials, IP, FP and ST samples; prepares standard and sample solutions as required by the test methods.
Performs wet chemistry tests such as Limit of Detection (LOD), pH and titration.
Performs physical tests and studies (particle size, viscosity, density, rheological measurements, microscopies and thermal analysis).
Performs all necessary calculations associated with test analyses.
Designs and executes pre‑formulation studies (pH solubility, pH stability and excipients compatibility studies) in collaboration with PD.
Executes designed studies to support laboratory investigations.
Performs non‑routine testing such as method comparisons and evaluations.
Documents all testing details and results in laboratory notebooks compliant with cGDPs.
Assists and trains lower‑level scientists.
Creates and reviews ARD SOPs as needed.
Cleans, maintains and calibrates laboratory instruments to ensure compliance with cGLPs and cGMPs.
Cleans and organizes ARD lab areas.
Performs related duties as assigned.
Qualifications
Bachelor’s degree in Chemistry or related science field and minimum 8 years’ experience in analytical/method development or method validation in the pharmaceutical or biotechnology field.
OR Master’s degree in Chemistry or related science field and minimum 5 years’ experience in analytical/method development or method validation.
OR PhD in Chemistry or related science field with 1‑3 years’ experience in analytical/method development or method validation in the pharmaceutical, biotechnology and/or academic research field.
Knowledge‑Skills‑Abilities
Understanding of spectroscopic and chromatographic techniques and concepts.
Hands‑on experience in setting up and operating multiple analytical instrumentation (HPLC, UV/Vis, GC, TLC, ICP‑MS and dissolution apparatus).
Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements.
Ability to perform analytical testing, calculations and data analysis.
Ability to perform wet chemistry and physical characterization studies.
Ability to train and mentor lower‑level scientist.
Proficiency with Microsoft Office.
Ability to work independently and collaboratively in a fast‑paced, matrixed, team environment.
Analytical thinking with problem‑solving skills and the ability to adapt to changing priorities and deadlines.
Planning, organization and time‑management skills including the ability to support and prioritize multiple projects.
Fluent in English (verbal and written).
Preferred
Proficiency with Empower software.
Travel Requirements 0%
Physical Requirements
Laboratory based position.
Ability to lift up to 30 lbs.
Ability to use Personal Protective Equipment (PPE).
Ability to stand for extended periods of time.
Compensation Pay rate for temp – $45‑55 per hour. Anticipated salary range for permanent employee – $95k to $115k.
Benefits
Medical, dental, vision, Rx insurance.
401K with match.
Life insurance.
Paid Company Holidays.
PTO.
Paid Volunteer Time.
Employee Resource Groups.
Equal Opportunity Employer Tris Pharma, Inc. is an Equal Opportunity Employer.
#J-18808-Ljbffr