Job Description Page2017-09-27T21:31:21+00:00

Associate Director Technical Operations

11/9/18

Chicago, IL 60290

2975

BS

FullTimeRegular

ASSOCIATE DIRECTOR TECHNICAL OPERATIONS

OVERVIEW

Our client is a 200 person progressive and publicly traded pharmaceutical organization focused on developing and commercializing branded products.

 

RESPONSIBILITIES

  • Manages and oversees tech transfer, launch, post-approval changes and routine commercial manufacturing activities at CMOs. This is an individual contributor role with no direct reports.
  • Oversees and plans product needs to ensure timely supply. Assist in preparation schedules and coordination of manufacturing activities.
  • Technical leadership in products with emphasis in process and manufacturing activities.
  • Helps create a manufacturing strategy for products, interfacing with Quality, Clinical, and Regulatory groups.
  • Writes/reviews batch records and protocols for manufacturing of drug products.
  • Writes /reviews development and validation technical reports 
  • Oversees clinical trial material manufacturing and packaging activities and manages budgets for those projects.
  • Works with Quality Systems to ensure implementation and maintenance of quality standards, meeting compliance/regulatory requirements. 
  • Supports manufacturing investigations and regulatory submissions. 

 

ADDITIONAL RESPONSIBILITIES/DUTIES 

  • This position will require up to 35 % travel to contract manufacturing facilities in the US and ex-US.

 

EDUCATION AND EXPERIENCE

  • BS or equivalent in Chemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field. An advanced degree in sciences would be a plus.
  • A minimum of 10 years of pharmaceutical or biotech industry experience, including late-stage development, process validation and commercial pharmaceutical cGMP manufacturing environments
  • Prior experience related to managing external CMOs is required. 
  • Prior experience in working at a commercial manufacturing site is a plus

 

SKILLS AND ABILITIES 

  • Strong knowledge of pharmaceutical cGMPs. 
  • Experience in leading cross-functional CMC teams to accomplish department goals 
  • Familiarity with risk management strategies
  • Ability to work strategically and independently with internal and external groups on multiple project
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