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Job Description Summary:

The Research Fellow, Chemical Process Development coordinates activities in Active Pharmaceutical Ingredients (API) process scale-up, process improvement and process optimization studies. The incumbent supports the transfer of technology to commercial manufacturing partners, monitors the manufacture of API and monitors stability data generated by Contract Manufacturing Organizations (CMOs). The incumbent works cross-functionally with internal departments and external partners on Process Chemistry related issues. The Research Fellow, Process Chemistry supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
.Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Designs, evaluates, and optimizes scale-up routes of small molecule candidates for pre-clinical testing.
• Assists in the identification, development, and implementation of policies, procedures and standards which impact the API manufacturing department, while working to ensure compliance with applicable regulatory requirements.
• Provides production process troubleshooting support to CDMOs including travel to external manufacturing facilities to monitor API production.
• Works with CDMOs in optimizing manufacturing processes in a stage appropriate manner.
• Compiles and maintains accurate records of laboratory experiments and data.
• Acts as API Subject Matter Expert on project teams.
• Partners with Regulatory in drafting Drug Substance sections in regulatory submissions.
• Works closely with Analytical Development in setting specifications for starting materials, intermediates and final products and supporting analytical validation.
• Interacts closely with Formulation Development to ensure API requirements and needs are met.
• Collaborates with Quality Assurance in adhering to GMP manufacturing quality standards.
• Supports Regulatory in responding to queries from regulatory agencies.
• Performs other tasks and assignments as needed and specified by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

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

• PhD in Organic Chemistry and a minimum of 7 years of experience in process chemistry in a pharmaceutical, biotechnology, CMO or related environment OR equivalent experience and/or education.

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

• Hands-on expertise and experience in modern synthetic organic chemistry and multi-step organic synthesis.
• Hands-on experience in compound purification, acquisition and interpretation of spectroscopic data from Nuclear Magnetic Resonance (NMR), Infrared spectroscopy (IR) and Mass Spectrometry (MS) and structure determination.
• Hands-on experience in conducting multi-channel experiments for the rapid optimization of reaction parameters.
• Hands-on experience searching chemical literature and using chemical reaction databases to determine viable approaches to synthetic and mechanistic chemistry problems.
• Experience using electronic lab notebook.
• Experience with Design of Experiments (DoEs) and Quality by Design (QbD).
• Working knowledge of Good Manufacturing Practice (GMP).
• Experience in technology transfer from lab scale to kilo-lab scale or to GMP manufacture.
• Experience in manufacture of API Registration batches.
• Experience in API process Quality Risk Assessment and Regulatory Starting Material studies.
• Proficiency with Microsoft Office.
• 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.

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

• Experience in managing CDMOs.
• Experience in API Manufacturing Validation.
• Experience in Commercial API manufacturing.

Travel requirements

• 5 - 15%

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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, p regnancy, 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.