Manager - Product Introduction; NPI) and Manufacturing Execution System; MES

Position: Manager - New Product Introduction (NPI) and Manufacturing Execution System (MES)
Career Category Manufacturing

Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year.

Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based.

If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manager-New Product Introduction (NPI) and Manufacturing Execution System (MES) What you will do Let’s do this. Let’s change the world. In this vital role you will act as the Downstream Manager for the New Product Introduction (NPI) and Manufacturing Execution Systems (MES) Team in B23 GMP Drug Substance Supply.

This position is within Amgen Thousand Oaks (ATO) Manufacturing and Clinical Supply - Manufacturing Systems organization. ATO B23 is a dynamic environment and an important launch point for Amgen’s pipeline products. The GMP DSS plant manufactures drug substance for clinical trials through commercial production using both stainless steel and single-use equipment platforms. This NPI/MES team is a key communication and technical interface between the GMP manufacturing operations teams in the plant and Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality.

Responsibilities:
Directly manage a team of Downstream NPI Specialists and MES Sr. Associates responsible for introduction of new products and/or advanced technologies into the plant, as well as Electronic Batch Record (E ) development and management. Includes hiring, training, oversight, performance evaluations, and development. Proactively assess team capabilities to meet the evolving drug substance clinical/commercial supply needs (ex. resources, platform technical understanding, cross-functional alignment).

Lead downstream area team meetings and drive alignment in business processes across the team. Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality, MES network, as well as Manufacturing for the introduction of new products, new/revised electronic batch records, and/or advanced technologies into the plant. Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.

Collaborate with Regulatory and Quality partners to ensure compliance of team change control records/documents and respond to regulatory questions and/or audit findings. Drive a culture of inspection readiness across the team by ensuring NPI and MES playbooks are kept up to date and supporting staff with audit or regulatory response strategy. What we expect of you We are all different, yet we all use our unique contributions to serve patients.

The dedicated professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

Doctorate degree OR Master’s degree and 3 years of biotechnology operations experience OR Bachelor’s…