Working closely with Amgen scientists to identify patentable subject matter; drafting, filing and prosecuting patent applications worldwide; conducting prior art searches; analyzing patents and preparing freedom-to-operate opinions.
The senior counsel will develop, implement and execute a global intellectual property strategy for companys therapeutic products and product candidates (e.G., antibodies and other large molecules), including formulations, process development or manufacturing methods relating to companys pipeline and in-line products.
The successful candidate will develop, implement and execute a global intellectual property strategy for companys process development organization which includes manufacturing relating to large molecules in companys biologics pipeline and in-line products. Areas of focus preferably relate to biologics manufacturing expertise including cell science, purification, analytics, fill finish, and automation processes related to our business.
In this role, the selected candidate will be responsible for ensuring that trade compliance incidents are promptly discovered and resolved and that the root cause of problems is identified and rectified with meaningful corrective actions.
The Senior Compliance Counsel will establish and maintain compliance infrastructure in accordance with applicable regulations and guidance with a particular focus on programs for manufacturers of pharmaceutical products.
This position is responsible for ensuring client operations comply with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations, antitrust, and FDA requirements.