QC Chemist II – Raw Materials API Job
Your Groundbreaking Journey
At Novo Nordisk, we want to make a difference. For more than 90 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help and improve the quality of life for millions of people around the world.
To help meet the growing demand for our diabetes treatment, Novo Nordisk expects to double production of diabetes drugs over the next decade. Novo Nordisk is currently building a new diabetes API plant in Clayton, NC next to our existing facility that employs 800 people. The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.
Novo Nordisk is currently seeking top talent for this green field project and eventual operations. This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build. Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.
No relocation assistance will be provided for this position.
Position Purpose: Plan, manage & perform laboratory method validation activities.
Routine review of laboratory validation procedures & validation protocols for accuracy & completeness.
Gather & ensure knowledge transfer & alignment on all QC Raw Material practices & procedures between Denmark & DAPI US ensuring coordination & collaboration with all relevant stakeholders.
Accountabilities:
- Method Validation & Testing process SME for QC Raw Materials.
- Document preparations including SOPs, method validation protocols & reports.
- Accuracy & scientific soundness of lab data.
- Timeliness of Lab Results.
- Ensure departmental documents are current & standardized.
- Perform nonconformity & change control activities.
- Systematic Problem Solving ownership.
- Lab Equipment Validation & System Availability support.
- Other duties as assigned.
Education: Mandatory
BS/BA in life sciences, chemistry, engineering, or relevant combination of education & experience.
Experience: Mandatory
- 3+ years of raw material experience in the pharmaceutical industry or related field.
- Method validation & verification experience.
- Experience writing & executing validation protocols.
Technical/Process/Functional Knowledge:
- Knowledge of GMPs, ICH guidelines & Pharmacopeia (USP/NF & Ph. Eur.) methods. Mandatory
- Able to perform GC, HPLC, FTIR, Titrations & Compendia Identification test. Mandatory
- Strong communication skills (verbal & written).
- Demonstrated ability to write technical & scientific documents & reports.
- Demonstrated ability to present technical & scientific documents & reports.
- Experience with validation of QC Instruments, Equipment Utilities & USP.
Organization/Planning: Demonstrated ability to manage multiple projects & competing priorities.
Physical & Other Requirements:
- Ability to work in & around an active construction site.
- Able to work with hazardous materials & chemicals.
- Corrected vision to 20/30.
- Able to lift 25 lbs. with assistance.
- Able to work extended hours to support manufacturing operations.
- Able to travel internationally.
The sourcing period for this position will end on 12 June 2018.
EEO Statement: Novo Nordisk is an Equal Opportunity Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.
Requisition ID: 56801BR
State/Provinces: Clayton
Job Category: Quality
Requirements:
Chemist, Chemistry, Diabetes, Engineer, Engineering, Facilities, Healthcare, Laboratory, Operations, Pharmaceutical, Science, Scientific, Scientist, Special Medicine
