Section Manager, Clinical Manufacturing New Product Introduction

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

The Section Manager has oversight of a team of manufacturing associates with responsibility for new product introduction, manufacturing scheduling, and documentation review. This centralized team supports three clinical GMP Manufacturing Suites with a diverse portfolio of early phase clinical production campaigns. This position reports to the Director of Clinical Manufacturing and sits on the leadership team. Oversight of facility fit, and new product introduction activities is critical to group success. Experience with mammalian cell-culture, monoclonal antibody BDS production, process transfer, and manufacturing scheduling is preferred.

• Manage a team of exempt manufacturing associates. Set performance expectations, assess performance, train and develop staff, and resolve personnel issues.

• Oversees the manufacturing review of batch records to support new product introduction and tech transfer into GMP manufacturing Suites.

• Develops manufacturing shop-floor schedules and coordinates resource reviews with manufacturing teams.

• Identifies opportunities to drive continuous improvement in tech transfer process and GMP documentation management.

• Significant Work Activities -Awkward/forceful/repetitive motions (arms above shoulders, bent wrists, etc.)

Qualifications

• Bachelor's degree in science, technology, or a related field required.

• 5-10 years of experience in Operations, Manufacturing, Engineering, or Process Development.

• Solid understanding of manufacturing processes and related supply activities

• Demonstrated success leading teams and developing individuals.

• Ability to collaborate and influence without authority in a matrix environment

• Strong oral/written communication skills; ability to listen to and