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Director / Sr. Director, Analytical Development
Job Code - AN0708

Spherics is an emerging venture-backed pharmaceutical company that is applying its novel platform technologies (50+ patents issued) to develop a pipeline of products with improved therapeutic profiles for treating  central nervous system (CNS) diseases.  These enabling technologies are also being used to provide delivery solutions for Pharmaceutical and Biotechnology companies developing new products and establishing lifecycle management programs.

We are looking for a Director or Senior Director of analytical development to lead a small department of analytical and bioanalytical teams who report through two managers.

Responsibilities include:

  • Support various development programs from polymer support, pre-IND through NDA submissions

  • Co-ordinate and optimize and track progress of projects (time and resources)
    and ensure adherence to plan and strategy

  • Work as part of a drug development supply chain and contribute
    to delivery of CMC packages of high quality

  • Provide the scientific and technological leadership and direction within the department

  • Define, establish and rigorously monitor go/no go criteria for all key decision points

  • Interact with CROs and vendors to ensure timely completion of project timelines

  • Coach direct reports for enhanced performance, team
    and individual development on an on-going basis

  • Evaluate and monitor our analytical systems and practices to assure compliance with regulatory requirements

  • Assist with maintenance and troubleshooting of analytical instrumentation

Requirements:

To succeed in this position, you must have a record of success managing multiple, concurrent programs in various phases of both preclinical and clinical development. You need excellent communication and management skills.

Education/Experience/Skills:

  • PhD with 8+ years of accomplished pharmaceutical drug development experience

  • Proven analytical and problem solving skills

  • Strong project and resource planning abilities

  • Must be a team player, self starter, persistent, persuasive and goal oriented

  • People development and outstanding leadership capability

  • CMC development experience mandatory

  • Thorough understanding of cGMP and ICH guidelines

 

Spherics (www.spherics.com) is located in Mansfield, MA,
30 miles south of Boston, near the intersection of Routes 95 and 495.

Spherics offers a competitive salary and benefits package commensurate with experience.
Equal opportunity employer.

Please e-mail resume/CV to hr@spherics.com (preferred),
fax to (508) 452-7070, or mail to:

Spherics, Inc.
375 Forbes Blvd.
Mansfield, MA 02048

 

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