Senior Engineer - Packaging
The Senior Engineer in Process Development (PD) position is located in Cambridge, MA and will report to a Senior manager (should this say Principal Engineer) of D&FDPT (Device and Final Drug Product) based in Thousand Oaks.
The candidate for this position will be responsible for Primary, secondary, and tertiary packaging development for the clinical and commercial small molecule packaging for drug substance, drug product (tablets), primary container closures and final product presentations. The Sr Engineer will create and implement the long-term strategy to ensure that Amgen becomes and remains an industry leader in this area. They will work cross functionally as a Device Technology Lead (DTL) within PD and across Amgen to develop products that create a successful patient experience.
The Senior engineer will help to develop annual goals and strategic direction for the packaging organization to the Product Development Team (PDT). Identify and drive efficiencies and utilization of the commercialization process, the lifecycle of products, and the overall manufacturing capability of Amgen operations across the global networks.
The Senior Engineer will also have the following responsibilities:
*DTL lead for all small molecule programs driving packaging strategy and milestone to the PDT
*Consistently deliver results aligned with departmental and program goals.
*Drive continuous improvement in the small molecules packaging processes from project initiation through launch as well as life cycle management. In alignment with regulatory and commercial manufacturing requirements.
*Creates an overall small molecule packaging strategy that ensures Amgen becomes and remains an industry leader.
*Be a role model in living the Amgen values and leadership attributes.
*Identify resource requirements to deliver on program portfolio and negotiate resource assignments from leadership.
*Deliver progress reports and presentations ensuring that management is aware of the current status, progress and future needs within Operations.
*Identify and ensure area of responsibility complies with the most current standards and company policies.
*Capable of authoring regulatory documents in support of small molecule applications.
*Provide leadership and guidance to ensure consultants, contract manufacturers, and external business partners comply with business standards and requirements.
Master's degree and 3 years of Engineering, Materials or Packaging experience
Bachelor's degree and 5 years of Engineering, Materials or Packaging experience
- MS in Materials Science, Mechanical Engineering, Chemical Engineering or Packaging Engineering
- 7 years of packaging materials experience with 4 years within the Pharma/Bio industry
- Independent thinker with demonstrated skills working in teams or leading project teams
- Strong Interpersonal and communication skills