Senior Manager Manufacturing, New Product Introduction/Lifecycle Management

The Senior Manager of Manufacturing, New Product Introduction/Lifecycle Management for B23 leads a team of manufacturing specialists and senior associates who are responsible for multiple support and operational readiness activities for the drug substance GMP manufacturing plant. This team has three primary functions:

• Operational readiness of Drug Substance plant for new products, resupply products, commercializing products and approved commercial products including new technology
• Ongoing product lifecycle management including change management, product alignment, scenario analysis, and continuous improvement
• Authoring and maintaining electronic batch records in the manufacturing execution system (MES)

The Senior Manager provides leadership to these three functions and is accountable for their performance and compliance. The Senior Manager will actively drive the improvement culture of the organization and be a role model in Lean Manufacturing culture and continuous improvement programs. They will act as a liaison between the manufacturing operations and Process Development, Operational Strategy Planning and Resourcing (OSPR), Supply Chain, Facilities & Engineering and Finance. In addition to these responsibilities the Senior Manager will be assigned some plant continuous improvement, safety and staff development responsibilities.

The Senior Manager is required to have extensive experience and understanding of drug substance manufacturing operations with knowledge of both upstream and downstream unit operations. Experience working with both stainless steel and single use manufacturing environments is necessary for success as is general understating of in-process and release analytics. Understanding of regulatory compliance requirements associated with manufacturing, change control and multiproduct facilities will ensure success. The Senior Manager will interact directly with regulatory agencies for their functions.

The Senior Manager needs to be a strong leader with excellent written and verbal communication, capable of motivating staff and delivering difficult messages. They will select and train staff, provide oversite and performance evaluations and set goals for team.

Basic Qualifications:

Doctorate degree and 2 years of Manufacturing & Operations experience

OR

Master's degree and 6 years of Manufacturing & Operations experience

OR

Bachelor's degree and 8 years of Manufacturing & Operations experience

OR

Associate's degree and 10 years of Manufacturing & Operations experience
OR
High school diploma / GED and 12 years of Manufacturing & Operations experience

Preferred Qualifications:

• 2 years of managerial experience directly managing people and 5 or more years leadership experience leading teams, projects, programs or directing the allocation of resources.
• Degree in Life Science, Chemistry or Engineering
• 7+ years of related manufacturing experience
• 5+ years of experience in an Area Supervisor/Manager role
• Ability to lead at all levels of the organization and effectively partner throughout the organization and across functions.
• Demonstrated project management and presentation skills
• Demonstrated experience with continuous improvement
• Demonstrated experience interacting directly with regulatory agencies in audits and inspections

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.