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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