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Senior Pharmaceutical Process Specialist
3 weeks ago
Job Title: Process Development Manager
GCF Level: 5
Career Category: Process Development
Location: ADL
Job Overview:
The Process Development Manager will report to the Sr. Manager Process Development for New Product Introduction (NPI) Technical Delivery and be responsible for technical delivery of NPIs and life cycle management (LCM) products to ADL.
Key Responsibilities:
- Manage a team of tech transfer engineers/scientists supporting new product introductions and lifecycle changes into the vial and syringe plants from a Process Development perspective.
- Lead tech transfers of NPIs and LCMs to ADL, providing technical support to large molecule and small molecule drug product manufacturing.
- Implement process improvement strategies, including troubleshooting issues with drug product processing technologies and equipment.
- Develop and characterize drug product processes, transferring technology to commercial drug product sites.
- Identify and implement operational opportunities for current and new sterile operations, ensuring site meets quality requirements of customers and applicable regulations.
Requirements:
- A third level Bachelor's degree in Science, Engineering or a relevant Quality discipline, or equivalent experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability, excellent oral and written communications skills, and strong leadership skills.
Preferred Qualifications:
- PhD or Masters in Science or Engineering.
- 5+ years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites), or Validation.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
What We Offer:
A challenging role with opportunities for growth and development in a dynamic organization.
Collaborative work environment with a talented team of professionals.
Opportunities for professional development and career advancement.
Competitive compensation and benefits package.
