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Associate Director Product Development - Pharm Science

Shire Pharmaceuticals Group

Lexington, MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Primary Role Under the direction of the Senior Product Development Director or Director, the Associate Director (AD) is responsible for supporting the Pharmaceutical Sciences Department with expertise in drug synthesis, drug formulation, product manufacturing, regulatory and analytical support, including development, validation, and data review for drug substances and drug products, for development of global products. The AD actively manages and oversees Shire contractors to the end of achieving Shire project and product development goals. The individual sets and defines product goals upon project inception and implements actions required in achieving the previously assigned product goals. The AD is expected to represent the Department on Product as well as Project teams, as deemed necessary. Responsibilities 80% * Manages and oversees the development of drug substances and drug formulations and/or transfer of development activities with Shire contractors. * Helps develop and manage budgets for R&D projects * Responsible for providing guidance to Shire contractors. * Monitors/supervises the manufacturing of drug products and drug substances with Shire contractors. * Writes/reviews protocols for manufacturing drug substances and drug products. * Writes/reviews analytical method protocols and stability protocols. * Writes CMC documents for registration purposes, including CTAs, IMPD, MAA, and responds to agency questions. * Provides any necessary support to line manager as required 20% * Is an active member of Project Teams and supports the Supply Chain PSL locally on market ed products * Assists in the development and implementation of departmental processes, procedures and policies. * Provides technical input for selecting external Shire contractors as well as managing the day-to-day contractor activities. * Assists in the review and evaluation of CMC documents during a due diligence exercise. Education & Experience Requirements * Bachelor's degree from college or university in Chemistry, Chemical Engineering, Pharmacy or closely related field and at least 7+ years experience in the Pharmaceutical Industry, or a M.S. in Chemistry, Chemical Engineering, Pharmacy or closely related field and 5+ years experience in the Pharmaceutical Industry, or a PhD in Pharmaceutical Sciences, Chemical Engineering, Pharmaceutics or closely related field and 3+ years of pharmaceutical industry experience. * Must have 3+ years experience in pharmaceutical formulation development and/or manufacturing for late stage clinical development candidates in oral solid dosage forms. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.


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