BASIC QUALIFICATIONS:

• A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications 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 skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.

KNOWLEDGE OF PROTEIN BIOCHEMISTRY REGARDING CHEMICAL AND PHYSICAL STABILITY

• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role.
  Amgen is an equal opportunities employer.

Please refer the Job description for details