Direct Hire - Process Associate, Downstream Development & Ops job Exton Pennsylv
Direct Hire - Process Associate, Downstream Development & Ops job Exton Pennsylv
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Direct Hire - Process Associate, Downstream Development & Ops Job



Employer Name: SpiderID: 7805178
Location: Exton, Pennsylvania Date Posted: 8/1/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH27496

Job Description:

Job Description



  • Participate in the routine operation of purification and formulation production equipment supporting the execution of GMP campaigns to produce clinical trial materials within this human health care pharmaceutical company . In addition, participate in the design and implementation of new processes, equipment and technologies for downstream manufacturing. Participation in other areas within the facility may be added at the company's discretion.


Responsibilities



  • Work in a hands-on capacity in the operation of downstream equipment for the manufacture of preclinical and phase I - III clinical trial materials.

  • Assist in the coordination of equipment maintenance, calibration, and (re)validation with appropriate internal departments.

  • Provide cross-functional support for other operational departments within the pilot plant at the discretion of management.

  • Provide support for the development, transfer and scale-up of new processes and technologies working with R&D and the technology transfer laboratory personnel. Support process performance monitoring, operational excellence activities, and assist in the implementation of process improvement strategies.

  • Assist in the preparation of bill of materials, batch records, SOPs, technical reports and campaign summaries.

  • Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines.

  • Assist in troubleshooting downstream production issues, deviations and process/equipment investigations.

  • Interact cross-functionally with Upstream Operations, Support Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful product development.


Qualifications
Education



  • BS or MS in Biological Sciences or Engineering or equivalent job experience/degree is strongly preferred.


Experience



  • Minimum of 3-5 years (BS) or 1-3 years (MS) in a multi-discipline cGMP environment, commissioning and operating equipment in downstream production areas.

  • Proficient in the operation of all area-specific production equipment such as chromatography columns and controllers, TFF skids, viral filtration technologies and CIP/SIP operations.

  • Experience in process development, technology transfer, scale-up, equipment validation and viral clearance studies.

  • Ability to identify, investigate, and trouble-shoot basic process and equipment problems.

  • Working knowledge of cGMP, EMEA, and JP regulations.


Must Haves:



  • Chromatography (any) , science background preferred, filtration experience


Skills



  • Good written and communication skills.

  • Good problem solving and interpersonal skills with the ability to work in a team environment required.




Please submit your resume for consideration. Once submitted, feel free to contact Rushi at 858-703-6733 for additional information.

Approx. Duration: Perm

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!

Connect with us on LinkedIn and see how we can impact your career!

Hired by Matrix Career Center: https://www.hiredbymatrix.com/find-work/open-positions/



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
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Contact Information:
Contact Name: Hired by Matrix, Inc. Company Type:
Company: Hired by Matrix, Inc.
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