M
Associate Scientist II - BioChemical Analysis
Mindlance
🇺🇸 United States
On-site
6 months ago
- Regulatory Compliance
6 months ago
Not enough detail in this posting to match
I. Position Overview
Associate Scientist II is primarily responsible for testing samples, drafting methods and reporting
data under cGMP regulatory guidance for Large Molecules/Biologics product development and
related stability studies.
In support of Large Molecules/Biologics Therapeutics, will execute laboratory testing using the
following techniques as required:
▪ Compendial assays, (i.e., appearance. pH, Osmolality, Particulate measurements, Viscosity
etc.)
▪ Karl Fischer
▪ UV-Vis
▪ HPLC/UPLC techniques/methods (e.g., SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis,
etc.)
▪ Aggregation techniques such as MFI, AUC, SEC-MALS
▪ Capillary and Gel Electrophoresis (e.g., CE-SDS, SDS-PAGE, icIEF, IEF, western blot, etc.)
▪ FTIR, CD, Intrinsic Fluorescence, DSC
▪ Other technologies/methodologies as required by management
II. Essential Functions
▪ Reads and follows Standard Operating procedures with attention to details
▪ Successfully trains on 1-2 methods and/or techniques mentioned above and performs adhoc
sample testing activities under cGMP as required
▪ Applies basic scientific and laboratory concepts and theories related to specific testing in the
group
▪ Follow cGMP requirements for legible, accurate and thorough documentation to meet
regulatory compliance. Supports drafting of simple methods, method forms and result reports.
▪ Adheres to policies, processes, and procedures for operating laboratory equipment in a safe
and compliant manner
▪ Understands the Catalent culture, programs, and communication processes regarding quality,
safety, and ethical practices
▪ All other duties as assigned
III. Position Requirements
Education and Experience:
▪ Bachelor’s Degree in Life Sciences or Physical Science field. No work experience required
2
Knowledge/Skills Requirements:
▪ Has basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry,
Biochemistry).
▪ Excellent written and verbal communications skills with internal customers, colleagues, and
supervisor
▪ Well organized with ability to multitask and be flexible with daily work schedule
▪ Ability to work effectively under pressure to meet deadlines
▪ Ability to pay attention to detail and exhibit critical thinking
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Associate Scientist II - BioChemical Analysis · Mindlance