Scientist II, Analytical Development

Job Description Summary:

The Scientist II, Analytical Development contributes to, and provides scientific Subject Matter Expertise (SME) for analysis of drug substance and drug product using various analytical methodologies in support of the analytical development group. These include, but may not be limited to, dissolution, moisture content and chromatographic techniques such as High-Performance Liquid Chromatography (HPLC) and Gas chromatography (GC). This involves collaborating with scientific leadership within the analytical development organization to help establish the characterization methods necessary to support the discovery, formulation development, process development and manufacturing of small molecule products. S/He is also responsible for communicating analytical results to project team leads as necessary. She/He provides supporting data and documents for setting specifications for Active Pharmaceutical Ingredient (API) and Drug Product (DP).
The incumbent may work cross-functionally with internal departments and external resources on Analytical Development-related activities.
The Scientist II, Analytical Development supports adherence to all regulatory requirements including providing technical input to Regulatory submissions and company Standard Operating Procedures (SOPs) including as appropriate.
.Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Performs routine analytical testing in support of the characterization, method development/optimization, methods transfer, and analytical support for drug process development. These include, but may not be limited to HPLC, GC and dissolution analysis. This also includes generating, reporting and archiving analytical data. 
• Assists the analytical development team in the analysis and interpretation of analytical results as necessary.
• Supports the analytical development group's daily operational needs by maintaining controls, standards, and reagent inventories.
• Works with the Chemical Process Development and Formulation Development team members to develop analytical methodologies for API and DP, respectively.
• Applies relevant scientific principles and techniques to analytical development problems.
• Maintains detailed, up to date, and witnessed laboratory notebooks.
• Contributes to the scientific advancement of activities conducted in-house or by Contract Research Organizations (CRSs)/Contract Manufacturing Organizations (CMOs).
• Provides technical expertise within the analytical development team to review analytical data and contribute to method development and product characterization. 
• May contribute to authoring and/or reviewing method development reports, SOPs, validation protocols/reports, comparability protocols and reports, specifications, justification of specifications and other relevant sections of regulatory filings. These include, but may not be limited to, INDs, IMPDs and NDAs. 
• Assists in advancing PTC’s scientific and regulatory capabilities by maintaining and actively advancing his/her knowledge regarding relevant topics. S/he may also participate in industry trade groups and conferences. 
• 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 Chemistry, Biology, Biochemistry or other related scientific discipline and 2 years of relevant experience OR a Master’s degree in in these same disciplines and a minimum of 4 years of relevant and progressively responsible experience in a pharmaceutical, biotechnology or similar environment OR a Bachelor’s degree in these same disciplines and a minimum of 6 years of the same experience.

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

• Demonstrated proficiency with various general laboratory techniques in chemistry/biochemistry.
• Applied and demonstrated expertise with UV, HPLC, UHPLC, pH, moisture content, dissolution, and other similar laboratory instrumentation and methodologies.
• Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization.
• 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 at various stages of development.

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

• Experience interacting with and managing CROs/CMOs. 
• Small company and/or start-up experience.
• Experience in providing supporting data and/or authoring eCTD sections of regulatory submissions is highly preferred.

* Travel & Physical requirements

• Up to 10%
• Office/Laboratory-based position

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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, 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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