Pennington, New Jersey

Job Description Summary:

The Sr. Specialist, Quality Operations supports the on-going enhancement of the PTC total quality system through quality oversight of manufacturing and QC operations. This position contributes to the overall quality compliance of the manufacturing floor and supporting laboratory activities.

This position supports the start-up activities for gene therapy manufacturing and requires close collaboration with Biologics Manufacturing, Plasmid Manufacturing, Quality Control (QC), and other Quality departments.

This individual will develop and perform assignments pertaining to quality on the floor operations, master batch record approvals, Standard Operating Procedures (SOP) approvals, inbound materials inspection/disposition, executed batch record review, cell bank disposition, and drug substance/drug product batch disposition and Facility GMP Work Order approvals. This individual may participate in the review/approval of QC-GxP assay qualifications/validations and method issuances.

The incumbent works cross-functionally with internal departments and external resources on quality related issues.

The Sr. Specialist, Quality Operations -supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate

Job Description:

The Sr. Specialist, Quality Operations supports the on-going enhancement of the PTC total quality system through quality oversight of manufacturing and QC operations. This position contributes to the overall quality compliance of the manufacturing floor and supporting laboratory activities.

This position supports the start-up activities for gene therapy manufacturing and requires close collaboration with Biologics Manufacturing, Plasmid Manufacturing, Quality Control (QC), and other Quality departments.

This individual will develop and perform assignments pertaining to quality on the floor operations, master batch record approvals, Standard Operating Procedures (SOP) approvals, inbound materials inspection/disposition, executed batch record review, cell bank disposition, and drug substance/drug product batch disposition and Facility GMP Work Order approvals. This individual may participate in the review/approval of QC-GxP assay qualifications/validations and method issuances.

The incumbent works cross-functionally with internal departments and external resources on quality related issues.

The Sr. Specialist, Quality Operations -supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate

Responsibilities:

• Contributes to the development, implementation, and execution of processes and procedures related to batch disposition for Gene Therapy Manufacturing. This may include, but may not be limited to the following functions:
  • Performs batch disposition for Gene Therapy Drug Substance, Drug Product, and Finished goods manufactured.
  • Performs executed Batch Records and laboratory records reviews.
  • Performs Cell Bank and Plasmid disposition, and oversees the usage, and lifecycle.
  • Compiles batch compliance documentation such as Certificates of Conformance/Compliance (CoCs), Certificates of Analysis (CoAs), TSE Statements.
  • Supports inbound materials disposition activities.

• Participates in PTC's Quality on the Floor Program for Gene Therapy and Plasmid Manufacturing. This may include, but may not be limited to the following functions:
  • Performs QA Area Release/Line Clearance Procedures and facility walkthroughs.
  • Performs QA "person-in-plant" type activities during manufacturing, filling, labeling, Visual inspection of filled vials, packaging, warehousing, and shipping activities.
  • Identifies and assists in the resolution of deviations.

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

Requirements

• Bachelor's degree in a scientific discipline and a minimum 4 years of experience in QA, manufacturing, or related role(s) in a pharmaceutical, biotechnology or related environment, and at least 2 of which have been in a CMC-focused QA role.

• Previous experience in a lab- or manufacturing-based role.

• Demonstrated understanding of biologics manufacturing.

• Working knowledge or experience with QC specific testing and assays such as HPLC, Electrophoresis (cIEF, CE-SDS), Solo-VPE, MFI and Particle Size Analysis, Karl Fischer, Bioassay, Biacore, ELISA, Residual Assays.

• Demonstrated understanding of batch record review and disposition requirements.

• Detailed/Demonstrated knowledge and understanding of GxP regulations and Health Authority requirements.

• Demonstrated understanding of Quality Management Systems including Deviation Management, Out of Specifications, Change Control

• Proficiency with Microsoft Office and experience with SAP, MAXIMO, Oracle, LIMS or other ERP systems.

• Excellent verbal and written communication 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.

• Familiarity with Regional Regulatory agencies such as FDA, EU, and EMA

•The ability to navigate and be familiar with compendial agencies such as USP and EP.

• Travel requirements up to 15%

*Physical requirements (only note if the job requires physical capacity beyond general office work)

This is an office- based position with frequent visits to adjacent buildings, the manufacturing floor, laboratories, and supporting warehouses. Requires the ability to gown into clean rooms and wear PPE. Requires light physical activity such as walking between buildings, transporting documents, standing for long periods of time, performing walkthroughs/inspection activities (e.g. crouching, using a step ladder).

**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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Pennington, New Jersey

PTC is a science-driven, patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for patients with rare disease.

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