QC Scientist
Location:
Somerville, NJ
Description:
A biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development. Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their 1st innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.LOCATION: Branchburg, NJDESCRIPTION: Conduct routine responsibilities as assigned by QC Stability management. Initiate stability studies within LIMS; manage the stability calendar; pull, aliquot and submit samples. Perform data integrity checks; maintain tracking spreadsheets. Revise SOPs. Apply cGMP practices during execution of all work tasks. Work and achieve problem resolution with supervision. This is intended to be a general assignment description and should not be construed as all inclusive.PRIMARY RESPONSIBILITIES: 1. Perform routine duties of the maintenance of the Stability Program and the stability data base. Complete all stability-related tasks with coworkers and testing laboratories. 2. Initiate stability studies in accordance with approved stability protocols. 3. Pull and aseptically aliquot stability samples for stability testing in a clean area. Concise and thorough documentation of work under GMP. Ensure timely delivery of stability samples to the appropriate drop off locations. 4. Perform stability data entry as needed. Ensure data integrity. Compilation and reporting of stability data to QC customers. 5. Exhibit good communication skills with the QC testing laboratories and facilitate the timely completion of testing and data entry. 6. Collaborate with senior team members; provide support for investigations related to stability data. 7. Write/revise SOPs. Conduct document reviews. Maintain spreadsheets used for tracking group responsibilities. 8. Update supervisor of progress at scheduled intervals. Seek additional guidance as needed.EXPERIENCE: 5-7yrs of either QC or developmental experience with protein therapeutics in a biotechnology setting; experience with cGMP QC manufacturing support is preferred.Working knowledge of cGMP.Excellent teamwork and communication skills. Attention to detail.Strong computer skills (Microsoft Office).Familiarity with LIMS database as it pertains to design, monitoring and tracking samples and data.Previous experience working within a cGMP compliant stability program for protein biopharmaceuticals is desired.Ability to work independently and achieve problem resolution with supervision.EDUCATION: Bachelors of Science DegreeOTHER REQUIREMENTS:Must be authorized to work in the USMust be within commutable distance to Central NJ Please submit resumes to: (click to respond)Listing originally posted at http://www.bullhornreach.com/job/589029_qc-scientist-somerville-nj?utm_source=oodle.com&utm_medium=referral&utm_content=job&utm_campaign=feeds1
Posted:
November 20 2012 on Oodle
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More About this Listing: QC Scientist
QC Scientist is a Science & Pharmaceutical Scientist Job located in Somerville NJ. Find other listings like QC Scientist by searching Oodle for Science & Pharmaceutical Scientist Jobs.
QC Scientist is a Science & Pharmaceutical Scientist Job located in Somerville NJ. Find other listings like QC Scientist by searching Oodle for Science & Pharmaceutical Scientist Jobs.