Manager Analytical Development

Job Description Summary:

The Contract, Analytical Development supports and contributes to client’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 Contract, Analytical Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. .

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

· 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 6 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 2 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 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 manage, support and prioritize multiple projects.

· Experience using electronic lab notebook.

· Track record of authorship of pertinent sections of successful regulatory submissions (INDs, 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 analysis.