The Principal Scientist, Analytical Development supports and contributes to PTC’s analytical development function for early stage and late stage development projects. He/She serves as an expert in analytical development for various pharmaceutical dosage forms; providing analytical support to the Process Chemistry and Formulation Development groups during the development and optimization of drug substance and drug product, respectively, for clinical needs. This position is responsible for the CMC analytical development of New Chemical Entities (NCEs) and oversees Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) to achieve the company goals for US and global markets.
The incumbent works cross-functionally with internal departments and external resources on analytical development related issues.
The Principal Scientist position requires the ability to identify and solve complex analytical issues such as atypical or out-of-specification/trend test results as well as those related to instrumentation and methodology(ies).
The Principal Scientist, Analytical Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Acts as an internal analytical leader and expert to support product development from project initiation to commercialization.
Develops analytical methods for New Chemical Entities (NCEs) and drug products.
Coordinates development of analytical and control tests for API, starting materials, process intermediates and drug product at PTC and at CMOs; facilitates 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), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), amendments, supplements, and annual reports; authors and reviews regulatory documents and responses.
Compiles data from internal and external sources and provides data summaries to management.
Assists in providing oversight for stability related work at CMOs.
Represents department as a subject matter expert (SME) in relevant analytical areas, as necessary.
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, and qualifies laboratory instrumentation.
This individual should be willing to learn new skills, assist on a wide variety of projects and be adaptable to conflicting and changing priorities.
Performs other tasks and assignments as needed and specified by management.
Complies with PTC’s laboratory safety guidances and completes trainings in a timely manner.
* Minimum level of education and years of relevant work experience.
Master’s degree in a relevant scientific discipline and a minimum of 7 years of analytical development experience in a pharmaceutical, biotechnology or other related environment OR a PhD in a relevant scientific discipline and a minimum of 5 years of analytical development experience in a pharmaceutical, biotechnology or other related environment OR equivalent education and / or experience.
* Special knowledge or skills needed and/or licenses or certificates required.
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), Nuclear Magnetic Resonance (NMR), 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 overseeing analytical activities at external CMOs, and ability to troubleshoot analytical methods.
Working knowledge of Laboratory Information Management Systems (LIMS) and computerized data systems.
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 Chemistry groups in developing analytical methods such as HPLC-UV for early phase formulation development.
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.
*Special knowledge or skills and/or licenses or certificates preferred.
Project management experience.
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.
Track record of authorship of pertinent sections of successful regulatory submissions (INDs, CTAs, NDAs, Abbreviated New Drug Applications (ANDAs), MAAs, Investigational Medicinal Product Dossiers (IMPDs)) leading to the commercialization of drug products.
Experience providing responses to questions from health authorities with respect to regulatory submissions.
Experience with statistical data and trend analysis for stability data.
Experience using electronic lab notebook.
* Travel requirements
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.