New Product Introduction Lead

BioSpace; Thousand Oaks (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Comprehensive benefits

Discretionary annual bonus

Stock-based incentives

Flexible work models

Job summary

Amgen, in Thousand Oaks, seeks a Senior Associate Manufacturing for the New Product Introduction team. You will lead the introduction of new products into the Drug Product facility, coordinating across Manufacturing, PD, QA and Facilities to ensure on-time NPIs and robust documentation.

The role requires strong technical writing, GMP understanding, and project management to drive Change Controls and maintain CDOCS records. Excellent cross-functional collaboration is essential.

Qualifications

• Masters or equivalent in Engineering, Biology, Chemistry, or Life Science.
• Bachelor's with 2 years biotechnology operations experience, or equivalent.
• Associates with 4 years biotechnology operations experience.
• High school diploma / GED with 6 years biotechnology operations experience.

Responsibilities

• Develop, maintain, and implement NPI project plans with cross-functional teams.
• Drive issue resolution and root cause analyses; escalate as needed.
• Articulate problem statements clearly to management.
• Own Change Controls in Trackwise per GMP procedures.
• Own NPI records in CDOCS (Veeva system).
• Lead cross-functional meetings to execute NPIs on schedule.
• Identify improvement opportunities and share Lessons Learned.
• Perform purposeful presence Gemba walks to identify process improvements.
• Report team and plant metrics for visibility.

Skills

Project management

Technical writing

Cross-functional collaboration

GMP knowledge

Education

Masters in Engineering or Life Science

Bachelor’s degree + 2 years biotech ops

Associates degree + 4 years biotech ops

High school diploma + 6 years biotech ops

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. 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, 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.

Senior Associate Manufacturing - Building 20 Drug Product Manufacturing New Product Introduction (NPI)

What you will do

Lets do this. Lets change the world. In this critical role for the Thousand Oaks Drug Product (DP) facility - also known as ATO B20 - you will be responsible for the introduction of new products into the manufacturing plant. ATO B20 serves as a key launch point for Amgen's new programs progressing through clinical development, and the Sr Associate Manufacturing role directly enables the production of these programs in the ATO facility. This Senior Associate Manufacturing role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20, reporting into the Manager Manufacturing Programs.

The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 has with a clinical and commercial product mix to the Amgen network. This role will function as the site interface between the Amgen network, e.g. Operations Strategy & Business Resilience, Product Delivery Teams, 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 NPI Lead 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 manufacturing process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. The NPI Lead will be responsible for leading cross-functional projects to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of the immediate team.

Senior Associate Manufacturing for the New Product Introduction team will be primarily responsible for:

• Maintain an organized way of working with NPI support groups (e.g. PD, Manufacturing, F&E, QA) 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 milestones.
• Resolving issues in a timely manner (i.e. drive Root Cause Analyses) and elevating cross-functional customer concern to various levels of management as appropriate.
• Able to clearly articulate problem statements verbally and in writing to management, with a quality-first mindset for recommendations for path forward
• Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
• Owning NPI record documents in CDOCS (Veeva system)
• Proactively leading cross-functional team meetings, to ensure NPI project(s) execute per schedule

Additional Responsibilities Include

• Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
• 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 and relevant lifecycle management strategies.
• Reporting on team and plant metrics to ensure visibility to team operations and deliverables.

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 an individual with these qualifications.

Basic Qualifications

• Masters degree in Engineering, Biology, Chemistry or Life Science Field OR
• Bachelors degree in Engineering, Biology, Chemistry or Life Science Field and 2 years of biotechnology operations experience OR
• Associates degree and 4 years of biotechnology operations experience OR
• High school diploma / GED and 6 years of biotechnology operations experience

Preferred Qualifications

• Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff of varying organizational levels in both presentation and technical writing forms
• Project Management Experience
• Understanding of/Experience in Drug Product Formulation and Vial/Syringe Filling operations in a GMP environment
• 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 of 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 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.