Manager - New Product Introduction (NPI) and Manufacturing Execution System (MES)

Amgen; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement plan

Stock incentives

Medical, dental and vision coverage

Discretionary bonus

Flexible work models

Job summary

Amgen is seeking a Downstream NPI/MES Manager for the B23 GMP Drug Substance Supply plant in Thousand Oaks. You will lead a team responsible for introducing new products and advanced technologies, developing EBRs, and aligning across PD, Quality, Supply Chain, and Facilities.

You will champion Lean and OE initiatives, ensure regulatory readiness, and drive continuous improvement in manufacturing processes, while coordinating with cross-functional teams and stakeholders.

Qualifications

• PhD or Master’s/Bachelor’s with biotechnology operations experience and leadership.
• Direct people management experience required beyond technical work.
• Experience with GMP operations and New Product Introduction (NPI).

Responsibilities

• Directly manage a team of Downstream NPI Specialists and MES Sr. Associates.
• Coordinate with PD, DSTE, Supply Chain, Planning, Facilities & Engineering, Quality, MES network, and Manufacturing.
• Drive Lean Transformation and OE initiatives across the plant.
• Ensure compliance of change control records/documents with Regulatory and Quality.

Skills

People management

Leadership

GMP operations

NPI

Process development

Project management

Data analysis

Education

Doctorate degree

Master’s degree + 3 years biotech ops

Bachelor’s degree + 5 years biotech ops

Associate’s degree + 10 years biotech ops

Tools

PAS X

Werum software

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 (EBR) 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 degree and 5 years of biotechnology operations experience OR
• Associate’s degree and 10 years of biotechnology operations experience

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• Degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry
• Experience leading/managing a team of direct reports
• Experience with PAS X, Werum software
• Experience in GMP operations, including New Product Introduction (NPI)
• Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
• Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to coach, mentor and/or cross train colleagues within core technical areas
• Background in lean manufacturing methodologies and operational excellence
• Experience in cross functional Project Management

What You Can Expect From Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.