Direct Hire - Principal Process Associate, Downstream Ops job Exton Pennsylvania
Direct Hire - Principal Process Associate, Downstream Ops job Exton Pennsylvania
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Direct Hire - Principal Process Associate, Downstream Ops Job



Employer Name: SpiderID: 8069380
Location: Exton, Pennsylvania Date Posted: 10/17/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH28153

Job Description:

Job Description



  • Under minimal supervision the Principal Process Associate of Downstream Operations will be responsible for supporting the routine operation of the downstream equipment and production suites in a cGMP biopharmaceutical pilot plant.

  • The individual will provide technical expertise for purification and formulation operations, as well as processes and systems supporting the manufacture of preclinical, phase I, II and III clinical trial materials.

  • The individual will lead/mentor entry level operators during routine operations.

  • Assisting in the transfer of new technologies/processes, operation and troubleshooting of purification and formulation process equipment, preparation and close-out of documentation, manufacture of downstream materials, and ensuring compliance to internal procedures and relevant regulations. As required the Principal Process Associate may also assist in the execution of process development studies, the implementation of process improvement strategies and evaluation of new technologies. The individual may participate and/or lead a subteam supporting a campaign.


Responsibilities



  • Provide hands-on support for the operation of downstream equipment to manufacture preclinical, phase I, II and III clinical trial materials. Coordinate and support equipment maintenance, calibration, and validation with appropriate internal departments. Preparation, review and close-out of documentation in support of batch release. Participation in other areas within the facility may be added at the companys discretion.

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

  • Participate in validation maintenance, re-qualification, and improvement of downstream production equipment, systems and processes. Participate in the design, implementation, and commissioning of new technologies for downstream manufacturing.

  • Assist in the preparation and review of bill of materials, cleaning verification/changeover protocols, batch records, SOPs, viral clearance documentation and campaign reports. As required, lead subteams supporting a campaign.

  • Assist in troubleshooting product and equipment issues and deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective and preventive actions.

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

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


Qualifications
Education:



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


Experience:



  • Minimum of 5-7 yrs in a multi-discipline cGMP environment, commissioning and operating equipment in Downstream and Support 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 operations.

  • Knowledgeable in process development, technology transfer, scale-up, and equipment validation.

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

  • Strong working knowledge of cGMP, EMEA, and JP regulations.

  • Good written and communication skills.

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

  • Experience in scale-up studies and process validation studies is a plus.




Please submit your resume for consideration. Once submitted, feel free to contact Sanka at 646-856-8903 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:
Overnight Travel:
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Contact Information:
Contact Name: Hired by Matrix, Inc. Company Type:
Company: Hired by Matrix, Inc.
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