ANALYTICAL SCIENTIST
WARREN, NJ
WARREN, NJ
Project Description:
The scientist will work independently to carry out laboratory based analytical methods, manage analytical method transfer and qualification, support QC activities and troubleshooting and participate in method life cycle management. Activities will be performed in accordance with cGLP/cGMP regulations, established business processes, protocols and applicable standard operational procedures.
- Manage analytical method transfer from development to QC. Author and review analytical method transfer protocol and report.
- The methods may include qPCR, flow cytometry, ELISA, cell counting et al.
- Author and review analytical method qualification protocols and report.
- Participate execution of analytical method qualification.
- Trained on analytical methods and work as SME for qPCR and flow cytometry methods to support QC activities, leading deviation investigation, identify root cause, provide solution for analytical method issues.
- Author and review SOPs as required.
- Perform tracking/trending of data to contribute to the life-cycle management of an analytical method.
- Coordinate method SME for QC analyst training.
- Have good communication skills and be able to work cross-functionally with QC, QA, analytical development and CRO. Build relationships with cross-functional team.
- Manage equipment procurement and coordinate equipment IQ/OQ.
- Maintain a basic knowledge of cell therapy development and awareness of competitive landscape.
- Ensure proper operation and perform routine maintenance of all laboratory equipment.
- Ensure that all equipment and personnel are remain in compliance with cGLP/cGMP, FDA/EMA requirement, appropriate SOPs and corporate policies.
- Maintain a safe workplace in accordance with company and OSHA policies/procedures.
- BS or MS in Biology or related discipline with 5+ years of recent, relevant experience.
- Knows the fundamental concepts of the specialty field.
- Experience of molecular assays, flow cytometry-based assays and cellular assays.
- Proficiency in analytical skills: statistical analysis and effective presentation of analysis to other groups.
- Strong verbal and written communication skills and interpersonal skills.
- Ability to write scientific technical protocols. Reports and SOPs that require minimal revision on content.
- Ability to work with minimal technical supervision and perform operational tasks independently.
- Able to assess risk and develop contingency plans to mitigate risk.
- Highly motivated and driven to acquire new skills.
- Expertise in mammalian cell culture and diverse analytical techniques preferred.
- Experience in working in a GMP regulated environment or QC is a plus.
- Comply with the Environmental Health and Safety Requirements.
Working Conditions:
- Work is performed both in a typical office setting and in an analytical development laboratory and/or QC lab for GMP manufacturing.
- Office duties are primarily performed seated, but laboratory related work requires intermittent standing and walking for up to 70% of the time.
- Laboratory work may involve working around potentially biohazardous materials (human blood, cells, tissue, reagents, solvents, and cryogenic materials) as well as operating process machinery.
- Required PPE determined by the site EHS Assessments are provided for personnel protection whenever appropriate.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Briana: [Link available when viewing the job]
ALPHA'S REQUIREMENT #21-03776
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Company:Alpha ConsultingLocation:Warren - New Jersey - United StatesJob Types:ContractPost Date:October 25, 2021Valid Through:November 24, 2021