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Bioprocess Technician - Upstream Processing (Mfg.) at PTC Therapeutics, Inc. in Pennington, New Jersey

Posted in Architecture 30+ days ago.

Type: Full-Time





Job Description:

Job Description Summary:

Job Description:

As a result of our continued expansion, the newly created Bioprocess Technician works within the Upstream Processing (Mfg) group to carry out the work duties as noted below.

The position works cross-functionally with internal departments and external resources on manufacturing related issues. 

The Bioprocess Technician – Upstream Processing supports adherence to relevant regulatory requirements and complies with company Standard Operating Procedures (SOPs) as appropriate. 

Primary duties/responsibilities:


  • Executes routine manufacturing assignments per written procedures and instruction.

  • Adheres to current Good Manufacturing Practices (cGMP) and SOPs.

  • Completes work instructions and maintains clean room environment to comply with regulatory requirements. 

  • Removes red bag waste as required with instruction.

  • Uses existing single use technology process consumables.

  • Reviews own work for completeness on executed documentation.  Supports the completion of batch documentation and performs SAP Transactions.

  • Executes planned work as part of a sub-team with more experienced operators.


The specific duties of this position include, but may not be limited to, the following.


  • Performing mammalian cell culture using aseptic techniques

  • Performing daily monitoring of mammalian cell cultures and bioreactors

  • Performing weighing and checking raw materials, assembling and cleaning process equipment, and monitoring processes

  • Operating primary production equipment such as disposable bioreactors, other disposable bioprocess equipment, and media preparation equipment

  • Conducting Safety and GMP self-auditing walkthroughs.

  • Logs and submits samples in Laboratory Information Management Systems (LIMS) and tracks the results.

  • Performs other tasks and assignments as needed and specified by management.  

* Minimum level of education and years of relevant work experience.

  • High school diploma or equivalent with 1 -3 years of directly relevant experience OR an Associates degree in a Life Science (no prior experience required).

* Special knowledge or skills needed and/or licenses or certificates required.


  • Proficiency with Microsoft Office.

  • Excellent verbal and written communication and skills.

  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. 

  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. 


*Special knowledge or skills and/or licenses or certificates preferred.


  • Familiarity with basic Chemistry and Biology concepts.

  • Experience with mammalian cell cultures.

  • Experience with aseptic technique.

           

* Travel requirements

                None.

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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