PTC Therapeutics, Inc.
Sr. Scientist, GxP Bioanalytical (Project Management)
The incumbent works cross-functionally with internal departments and external resources as part of PTC's drug development teams. He/She will be coordinating and executing bioanalytical studies within clinical / preclinical projects, interpreting data and providing timely support to the broader development program(s) including regulatory submissions.
The Senior Scientist, Bioanalysis supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Primary duties/responsibilities:
Develops and implements bioanalytical methods for small molecules programs to support in house bioanalysis of preclinical and clinical studies
Provides direct oversight and interacts with the external Contract Research Organizations (CROs) responsible for conducting the quantitative analysis of biological samples in support of small and large molecules clinical and/or preclinical development. This may include those governed by FDA or other global health authority regulations.
Develops and implements Standard Operating Procedures (SOPs) for managing GCP and GLP bioanalytical projects conducted by external CRO(s).
Collaborates with clinical / preclinical drug development program teams. Defines, coordinates, manages and oversees the bioanalytical project timeline.
Responsible for the scientific quality of the bioanalytical projects in support of clinical and/or preclinical development.
Represents the bioanalysis function on the development program teams and presents results, timelines, etc. at project team meetings.
Performs other tasks and assignments as needed and specified by management.
Independently plans, initiates, directs and executes scientific research and experiments and interprets and communicates results as part of multi-disciplinary team(s).
Abides by all safety and regulatory guidelines.
Maintains a detailed laboratory notebook.
Performs other tasks as assigned.
Contributes to general lab needs such as:
Equipment maintenance.
Capital equipment purchases.
Troubleshoot
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Experience in regulated bioanalysis of clinical / preclinical samples (plasma, urine, etc.) using LC-MS/MS techniques.
Experience in developing bioanalytical LC-MS/MS methods in various biological matrices.
* Minimum level of education and years of relevant work experience.
PhD in Chemistry, Biochemistry, Pharmaceutical Science, pharmacology, or other related scientific disciplines and with a minimum of 5 years of post-PhD experience.
* Special knowledge or skills needed and/or licenses or certificates required.
Experience managing multiple projects with competing priorities.
Demonstrated experience in writing study reports and regulatory documents. Ability to influence without direct authority.
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.
Experience in writing analytical reports.
Experience in working within or with a Contract Research Organization (CRO).
Prior experience with large molecule bioanalysis, cell-based assays, ligand binding assays and immunogenicity assay is a plus.
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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