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Senior Chemist 1
2 weeks ago
Senior Chemist 1 - Physical Chemistry
Location - Singapore #LI Hybrid
About the Role:
Establish and maintain testing of drug substance release and stability testing including testing of intermediates in process control samples in accordance with written testing SOP’s and in accordance with written testing SOP’s and local/international regulations.
Key Responsibilities:
- Deliver accurate and timely lab test results and solutions to ensure full cGMP-compliance of IPC/DS (In Process control/ Drug substances) shift team.
- Provides technical support to run and validate necessary test methods on lab equipment and resolve issues in day to day lab operations including troubleshooting of lab equipment and processes and liaising with manufacturing teams.
- Leads in developing method transfer/validation protocols, lab equipment qualification and improvement project
- Act as SME (Subject Matter Experts) to train and guide site personnel to perform new methods and instrumentation, other lab related areas and audit preparation.
- Carry out investigations and establish root cause and prepare report findings according to global and local standards and requirements.
- Monitoring and optimization of work flows and methods/procedures, drug substance control, method controls and reference’s and performs trending of on-going in process control data to pursue an on-going quality assurance program.
- Reviews all lab related QC documents to ensure completeness, accuracy, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs.
- Recommend and execute improvement of existing processes or systems to deliver set KPIs.
- Able to support rotating shift hours (Day/night)
**Commitment to Diversity & Inclusion**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
Essential Requirements:
- 7+ years industry experience, preferably in a cGMP environment.
- Related experience should be in GMP-regulated industries in Quality Control.
- Must have a working knowledge of FDA and ex-USA regulatory requirements as well as industry quality management tools, standard, and quality systems.
- Must have an understanding of pharmaceutical industry trends and practices.
- Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
Desirable Requirements:
- MSc or BS in Pharmacy, Biotechnology, or Chemistry
**Division**
Operations
**Business Unit**
QUALITY
**Country**
Singapore
**Work Location**
Singapore
**Company/Legal Entity**
NOV SINGAPORE PHARMA MANUFG
**Functional Area**
Quality
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
