Associate Director Technical Operations
Chicago, IL 60290
ASSOCIATE DIRECTOR TECHNICAL OPERATIONS
Our client is a 200 person progressive and publicly traded pharmaceutical organization focused on developing and commercializing branded products.
- 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.
- 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