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

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll 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 youll 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

Lets do this. Lets change the this vital role you will act as the 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 Amgens 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 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 upstream/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

Masters degree and 3 years of biotechnology operations experience

Or

Bachelors degree and 5 years of biotechnology operations experience

Or

Associates degree and 10 years of biotechnology operations experience

Or

High school diploma / GED and 12 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 or 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 well 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 including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

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.

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.

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