Associate Director, Analytical Development

Proclinical is currently seeking an Associate Director, Analytical Development for a pharmaceutical company located in New Jersey. Successful candidate will work collaboratively with cross-functional teams in support of drug development activities and is directly responsible for all aspects of analytical support for assigned projects. The position collaborates with colleagues in Process Development, Formulation Development, Safety Assessment, Quality Assurance, and Regulatory Affairs to ensure high quality, on time delivery to ensure on-time progression of Pre-Clinical, Clinical and Commercial programs.

Job Responsibilities

• Leading drug development Analytical activities to address key issues.
• Writing and reviewing technical documentation for regulatory submissions.
• Proposing appropriate drug substance and drug product specifications based on batch data and regulatory expectations.
• Assessing stability data and proposing shelf lives and retest dates that ensure the quality and safety of drug substances and drug products.
• Establishing external contracts with analytical CROs.
• Monitoring, reviewing and guiding the analytical activities at these laboratories to ensure timely delivery of quality analytical work packages.
• Acting as a technical advisor on analytical techniques used for qualitative and quantitative analysis of drug substance.
• Directing and/or performing hands-on laboratory work to solve atypical technical issues as needed.
• Implementing new and innovative analytical methods, and improving existing ones as needed.
• Authoring and reviewing SOPs to ensure quality and compliance within CMC.

Skills and Requirements

• MS or PhD required in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences or other relevant field.
• 10 years of pharmaceutical R&D experience. Must have thorough knowledge of GMP, Industry, and Regulatory requirements.
• Experienced in GMP, Industry and Regulatory requirements.
• Experience with authoring NDA/MAAs.
• Excellent oral and written communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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