Alphanumeric Systems Inc.
Bench Scientist
King of Prussia, Pennsylvania•Contract
$42 - $46 hourly
$42 - $46 hourly
About the Job
Alphanumeric is hiring a BENCH SCIENTIST to work in King of Prussia, PA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.
Pay Range: $42 - $46/hour W2
Key Responsibilities: Testing drug product and drug substance samples for release, stability, and in-process
Duties:
- Perform and train others on physical testing of laboratory samples (drug product, drug substance, in-process, etc) utilizing various chemical and biochemical techniques including Immunoassay and Separations, (see Section C for details).
- Prepare laboratory samples for analysis and prepares laboratory standards and solutions.
- Manage samples and associated documentation for duration of sample lifecycle, both physically and electronically.
- Author and participate in laboratory investigations.
- Author, review, and revise SOP's and support Electronic Notebook template development (testing electronic lab notebook templates, author user requirement specifications, etc)
- Reviews and approves laboratory data.
- Performs routine departmental GMP activities (lab instrument calibrations, preventive maintenance, audits, work orders, etc).
- Support analytical and instrument lifecycle, technical transfer, and/or validation.
- Laboratory upkeep, maintenance, and continuous improvement (5S, routine equipment/glassware cleaning, etc).
Knowledge/ Education / Experience Required:
A. Educational Background
Minimum Level of Education: Bachelor's degree
Area of specialization: Chemistry, Biochemistry, Biology or Microbiology or science related field.
Why is this Level of Education Required? Foundational scientific knowledge and technical skills for working in the lab
A. Educational Background
Minimum Level of Education: Bachelor's degree
Area of specialization: Chemistry, Biochemistry, Biology or Microbiology or science related field.
Why is this Level of Education Required? Foundational scientific knowledge and technical skills for working in the lab
B. Job-Related Experience:
Minimum Level of Job-Related Experience required: 2 years
Why is this Level of Experience Required? Experience with laboratory testing as well as a strong understanding of cGMPs and compliance are necessary to execute job functions.
C. Other Job-Related Skills/Background:
Minimum Level of Job-Related Experience required: 2 years
Why is this Level of Experience Required? Experience with laboratory testing as well as a strong understanding of cGMPs and compliance are necessary to execute job functions.
C. Other Job-Related Skills/Background:
- Biopharmaceutical testing experience is required, ability to learn various techniques and assays. Assays include (but not limited to) – ELISA (protein A, HCP), cIEF (iCE3, Maurice).
- Strong understanding of cGMPs and compliance.
- System experience preferred – SAP/ERP, LES, LES-EM, Webstatistica, Empower, Hamilton (automated liquid handling), analytical instrument software (SoftMax, etc).
- Experience with MS Excel, Word, PowerPoint.
- Working knowledge of cGXP, ICH guidelines, FDA, USP/EP/JP and data integrity guidelines and regulations.