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

Job Description:

Job Description Summary:

Job Description:

As part of our continued growth, the Bioprocess Technician will work within the Downstream Processing group.  The Bioprocess Technician will perform the following activities while executing downstream operations:

• Preparation of solutions


• Filtration


• Chromatograph


• Tangential flow filtration


• Homogenizing


• Drug substance formulation


• Drug product formulation


• Drug product vial filling

The incumbent works cross-functionally with internal departments and external resources on downstream gene therapy manufacturing related issues. 

The incumbent supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

Primary duties/responsibilities:

• Executes routine manufacturing assignments per written procedures.


• Adheres to current Good Manufacturing Practices (cGMP) and Standard Operation Procedures.


• Performs protein purification using aseptic techniques.


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


• Completes work instructions and maintains clean room environment to comply with regulatory requirements.  Removes biohazardous and lab waste as required.


• Operates primary production equipment such as chromatography skids, disposable bags, and other disposable equipment, and solution preparation equipment.


• Supports Operational Excellence cross-functional project teams including, but not limited to, Development, Quality, Analytics, Logistics, Facilities and Document Center.


• Supports investigating of deviations for root cause.


• Supports the implementation of Corrective and Preventative Actions (CAPA).


• Uses existing single use technology process consumables.


• Conducts Safety and GMP self-auditing walkthroughs.


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


• Reviews own work for completeness on executed Master Batch Records (MBRS)s.  Supports the completion of batch records and performs SAP Transactions.


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


• 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 discipline (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. 

* Travel requirements

None

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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