NPI / MES Manufacturing Specialist

BioSpace; Thousand Oaks (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

A leading biotech company is seeking an NPI / MES Manufacturing Specialist in Thousand Oaks, CA. This role will lead the introduction of clinical products into manufacturing and act as a subject-matter expert in project management and manufacturing execution systems. Ideal candidates will possess strong technical expertise in GMP manufacturing and project management to ensure effective collaboration across teams.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan with generous company contributions

Flexible work models including remote and hybrid arrangements

Stock-based long-term incentives

Award-winning time-off plans

Qualifications

• Project management experience managing cross-functional teams.
• Understanding of Drug Product Formulation and Vial/Syringe Filling operations.
• Direct experience with regulated environments (e.g. cGMP).

Responsibilities

• Develop and implement the NPI project plans, maintaining scope, schedule, and risk management.
• Lead cross-functional teams to ensure plant operations align with long-term strategy.
• Communicate project status to senior leadership clearly.

Skills

Project Management

Quantitative/Analytical Troubleshooting

Collaboration

Education

Doctorate degree

Masters degree and 2 years of GMP manufacturing experience

Bachelors degree and 4 years of GMP manufacturing experience

Associates degree and 8 years of GMP manufacturing experience

High school diploma / GED and 10 years of GMP manufacturing experience

Tools

Kroeber PAS|X

SAP

Job description

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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.

Specialist Manufacturing - New Product Introduction & Manufacturing Execution System

What You Will Do

Lets do this. Lets change the world. In this vital role you will be responsible for the introduction of clinical new products into the manufacturing plant, as well as design electronic batch records supporting these introductions. This Specialist Manufacturing role will serve as a New Product Introduction (NPI) Lead and Manufacturing Execution System (MES) subject-matter expert within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20.

The Specialist is expected to have ownership over NPI and MES Project Planning and Execution, an activity that is vital to the impact that ATO B20 with a clinical and commercial product mix has to the Amgen network. This role will function as the site interface between the Amgen network, e.g. Product Delivery Teams, MES Standardization & Process Transformation team, and the B20 site consisting of 5 key functions: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of interactions and collaboration is required across these groups, and the Specialist needs to be able to understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines.

Candidates will need to demonstrate knowledge of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, quantitative / analytical troubleshooting skills, and Kroeber PAS|X. The Specialist will be responsible for leading cross-functional projects to deliver projects / deliverables on time through effective indirect people management and effective communication, both within and outside of the immediate team.

Responsibilities

• Working with NPI support groups to develop, maintain, and implement the NPI
  
  
  

project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project achievements.

• Leading cross-functional cases to ensure that the plant is operating according to its long-term strategy.
• Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
• Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures, on a Right-First-Time basis.
• Proactively leading cross-functional team meetings, to ensure project(s) and other relevant cases complete per schedule.
• Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.
• Generate and validate Manufacturing Electronic Batch Record (EBR) using Kroeber PAS|X.
• Assist in implementation of new MES functionality - Equipment Management (EQM), PCS MBR Elements, Level 2 Integration.
• Contribute to Lean Transformation through recording NPI/EBR metrics and application of continuous improvement tools.
• Engage with the rest of the Amgen network to assess EBR differences and identify path forward toward higher-effectiveness way-of-working.
• Provide on-call support to Manufacturing Operators, as needed.
  
  
  

Additional Responsibilities include:

• Holding supporting functions accountable for delivery of project tasks through documentation of Lessons Learned and presentation to management.
• Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
• Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
• Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs, relevant lifecycle management strategies, and EBR implementation.
• Reporting on team and plant metrics to ensure awareness of team operations and results.
• Representing the team at plant-wide and network-wide forums, as needed.
  
  
  

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a collaborative partner with these qualifications.

Basic Qualifications

Doctorate degree

Or

Masters degree and 2 years of GMP manufacturing experience

Or

Bachelors degree and 4 years of GMP manufacturing experience

Or

Associates degree and 8 years of GMP manufacturing experience

Or

High school diploma / GED and 10 years of GMP manufacturing experience

Preferred Qualifications

• Project Management experience
• Direct and/or indirect people management / leadership experience
• Understanding of Drug Product Formulation and Vial/Syringe Filling operations
• Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
• Experience with Kroeber PAS|X, SAP, and system integration platforms such as Kepware Middleware, PI Historian, Rockwell etc.
• Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
• Independent, self-motivated, able to multi-task in a fast-paced environment
• Team-player
• Demonstrated flexibility and ability to manage change
• Direct experience with regulated environments (e.g., cGMP etc.)
  
  
  

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.

careers.amgen.com

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

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