Senior Scientist, Analytical Development

ptcbio; New Jersey; On-site; USD 120,000 - 170,000; Full time

Job summary

PTC Therapeutics in New Jersey seeks a Senior Scientist, Analytical Development to lead method development, transfer, and validation of analytical techniques such as HPLC, LC-MS, and GC-MS for API and drug products. You will coordinate external CMOs/ CROs and ensure regulatory alignment.

The role requires a master’s or PhD in chemistry or related field with 4–5+ years’ experience in pharma analytics; you’ll work cross-functionally with QA, formulation, and manufacturing, and support IND/NDA

Qualifications

• Master's degree (Chemistry/Biochemistry/Pharmacy) with 5+ years analytical development in pharma or PhD with 4+ years in analytics.
• Extensive experience in developing/validating SOPs across analytical methods (HPLC, LC/MS, GC/MS, dissolution, etc.).
• Strong knowledge of regulatory GMP/ICH guidelines and 21 CFR related to CMC.

Responsibilities

• Develops analytical methods for NCEs and drug products using chromatography.
• Oversees transfer/validation of methods at CMOs and CROs.
• Performs data reviews and supports INDs/ NDAs/ MAAs with regulatory documents.

Skills

Analytical development

Cross-functional collaboration

Regulatory awareness

SME leadership

Education

Master's degree in Chemistry/Biochemistry/Pharmacy

PhD in Chemistry/Biochemistry/Pharmacy

Tools

HPLC

LC/MS

GC/MS

SOP development

LIMS/Empower

Job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team , fostering a strong sense of belonging.

Visit our website to learn more about our company and culture! Site: www.ptcbio.com

Job Description Summary:

The Senior Scientist, Analytical Development supports and contributes to PTC's analytical development function for early stage and late-stage development projects. The incumbent develops, implements, validates, transfers and troubleshoots a variety of analytical methods (e.g. Chromatographic methods) used for in-process evaluation, releases of Active Pharmaceutical Ingredients (API), and bulk and final drug products at Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs/CDMOs). He/she also provides analytical support for clinical formulation development.

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

The Senior Scientist, Analytical Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

ESSENTIAL FUNCTIONS

• Conducts analytical method development for New Chemical Entities (NCEs) and drug products using chromatography and other analytical techniques.
• Coordinates development of analytical and control tests for API, starting materials, process intermediates and drug product at PTC and at CMOs; provides oversight and direction for analytical method transfer and validation at external CMOs.
• Coordinates requirements and acquisition of analytical documentation/data/reports needed to support, or to be included in, submissions to Investigational New Drug applications (INDs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), amendments, supplements, and annual reports; authors and reviews regulatory documents and responses.
• Perform investigations and unknown impurity identifications in in-house lab using High Pressure Liquid Chromatography (HPLC), Liquid Chromatography/Mass Spectrometry (LC/MS) and Gas Chromatography/Mass Spectrometry (GC/MS).
• Assists in providing oversight for all stability related work at CROs/CMOs/CDMOs.
• Represents department as a subject matter expert (SME) in relevant analytical areas, as needed.
• Complies data from internal and external sources and provides data summaries to management.
• Conducts a second analyst review of analytical data and work, as needed.
• Provides analytical support to early and late stage discovery programs, as needed.
• Coordinates analytical development related activities within the company and external contractors as needed.
• Purchases required lab supplies, maintains instruments, purchases, installs, qualifies laboratory instrumentation.
• 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.
• Master's degree in a Chemistry, Biochemistry or Pharmacy related discipline and a minimum of 5+ years of analytical development experience in a pharmaceutical, biotechnology or other related industries OR a PhD in a Chemistry, Biochemistry or Pharmacy related discipline and a minimum of 4+ years of analytical development experience in a pharmaceutical, biotechnology or other related industries.
• Special knowledge or skills needed and/or licenses or certificates required.
• Extensive experience in the development, validation, and implementation of analytical Standard Operating Procedures (SOPs) that employ a range of analytical methods (e.g., High Pressure Liquid Chromatography (HPLC), Liquid Chromatography/Mass Spectrometry (LC/MS), Gas Chromatography/Mass Spectrometry (GC/MS), dissolution, particle size, moisture content, etc.).
• Hands-on experience with the identification, sourcing, and maintenance of analytical instruments.
• Demonstrated experience in troubleshooting of analytical methods.
• Working knowledge of US and international Chemistry, Manufacturing and Control (CMC) regulations and guidance, including Good Manufacturing Practice (GMP), the US Code of Federal Regulations (21CFR) and International Conference of Harmonization (ICH) guidelines is desirable.
• Working knowledge of Laboratory Information Management Systems (LIMS) and Chromatographic data systems (e.g. Empower®).
• Management of reference standards for internal and external needs, as necessary.
• Experience reviewing analytical data (at release and stability).
• Experience with designing and executing forced degradation studies for NCEs.
• Hands-on experience collaborating with the Formulations and Medicinal Chemistr