Key skills
Communication
About this role
Role Overview
- Perform & review analysis of in-process, release & stability samples of API &/or filled product in accordance with cGMP, site & corporate procedures & policies.
- Transfer of technology & processes in accordance with relevant project plans & timelines.
- Ensure accuracy & scientific soundness of lab data
- Ensure environmental compliance
- Support & ensure GMP Laboratory Compliance
- Maintain testing proficiency for methods
- Ensure timeliness of lab results & investigations
- Perform analysis of samples
- Support deviations
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned
Requirements
- Associate’s degree in science or a relevant field of study from an accredited university required
- Bachelor’s Degree in science or a relevant field of study from an accredited university preferred
- One (1) year of work experience in a clinical or industrial/pharmaceutical laboratory preferred
- Ability to author scientific & technical reports is a plus
- Able to perform routine testing per SOP & GMP standards preferred
- Basic level of troubleshooting for laboratory equipment is a plus
- Knowledgeable in GMP & laboratory techniques is a plus
- Demonstrate attention to detail required
- Strong communication skills (verbal & written) preferred
- Skills or knowledge in one of the following disciplines: Chemistry Analysis (HPLC, UPLC, GC, TOC, AA, UV, PH, KF), Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin testing, Growth Promotion and Microbial Identification, ELISA, BIOBURDEN) or Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration and UV-Vis) is a plus
Benefits
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards