Associate Scientist II, Raw Materials Disposition at PTC Therapeutics, Inc. in Pennington, New Jersey

Job Description:

Job Description Summary:

The Associate Scientist II, Quality Assurance – Raw Materials Disposition, Gene Therapy supports the on-going enhancement of the PTC total quality system by performing Quality Assurance (QA) functions related to the disposition of Raw Materials/Consumables. This position enables the manufacture of clinical and commercial gene therapy products while ensuring product quality through the control of incoming materials.

The Associate Scientist II, Quality Assurance- Raw Materials Disposition, Gene Therapy develops, implements, and executes procedures for the timely and compliant testing and disposition of raw materials and consumables.

The incumbent works cross-functionally with internal departments such as manufacturing, logistics, QC, and external vendors on Quality-related issues.

The Associate Scientist II, Quality Assurance – Raw Materials Disposition, Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate

Job Description:

Responsibilities

•             Lab responsibilities include raw material testing and release, sampling of raw materials, and disposition of consumables

o             Methods of testing include FTIR, Raman, HPLC-CAD, Description, Osmolality, pH, wet chemistry

o             Develops novel testing methods for the identification of raw materials

o             Performs method and material qualifications and validations

o             Aides in the sampling and disposition of raw materials

o             Performs manufacturing consumable and processing aids inspections and release

o             Maintains sample and reference material inventory

o             Qualifies and validates new laboratory instrumentation

•             Supports activities related to vendor/material approval and management of Contract Testing Laboratories

o             Authors and reviews new specifications for raw materials and consumables

o             Data and material management via electronic systems such as LIMS and SAP

o             Manages outsourcing of raw materials for Contract Lab Testing

o             Authors or revises procedural SOP’s and testing methods

o             Participates in Vendor Audits and the review of quality agreement

•             May contribute to and participate in vendor change notification program.

•             May assesses new incoming raw materials and proposes testing plans.

•             Supports QA system and procedure changes to enhance overall job performance and QA functions.

•             Maintains electronic and paper-based documentation, as needed.

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

Qualifications:

• Master’s degree in a related scientific discipline and a minimum of 4 years of relevant experience in a QA, logistics or related role OR a Bachelor’s degree in these same disciplines and a minimum of 6 years of relevant experience.


• Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.


• Experience with SAP, LIMS, ELN, Veeva Vault Quality Document Management System or equivalent


• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.


• Knowledge of biopharmaceutical manufacturing process workflows


• Proficiency with Microsoft Office and Excel.


• 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.

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

• Experience working directly with the FDA or other health authorities.


• QC laboratory experience


• Experience with Quality Risk Management and Quality Management Systems such as Deviation Investigations and CAPAs.


• Travel requirements - 0 - 15%  


• Physical requirements - Office/Laboratory-based position. Requires the ability to lift items weighing up to 15kg. 

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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