Company Overview: This
company was founded over three decades ago and has pioneered and focused on areas of high unmet medical needs. They have
leveraged their expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.
They have become one of the world’s leading independent biotechnology companies. Continued growth has resulted in
the need for a Senior Engineer-Packaging who will be based at their Northeast location.
Senior Engineer - Packaging 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 Company
becomes and remains an industry leader in this area. They will work cross functionally as a Device Technology Lead (DTL)
within PD and across the company to develop products that create a successful patient experience. In addition, he.
or she 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 the company operations across the global networks.
· Device Technology lead for all
small molecule programs driving packaging strategy and milestone to the Product Development Team.
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 Company becomes and remains an industry leader.
a role model in living the Company values and leadership attributes.
· Identify resource
requirements to deliver on program portfolio and negotiate resource assignments from leadership.
progress reports and presentations ensuring that management is aware of the current status, progress and future needs within
Identify and ensure area of responsibility complies with the most current standards and company
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.