Process Development Associate Director

Career Category

Process Development

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. 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.

Process Development Associate Director

What you will do

Let’s do this. Let’s change the world. IIn this role the Associate Director Engineering will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP product portfolio at the Amgen Ohio manufacturing site. The position is a leadership role in the Process Development group and the candidate must manage and/or apply extensive technical expertise in the coordination of combination products, tech transfer, characterization, forensic analysis and vials. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, validation, pilot plant, new product introductions and manufacturing support projects.

Project Management

Key responsibilities will include leading the New Product Introduction (NPI) process, Equipment Characterization and Validation for all GMP equipment and processes at the AOH site. Additional responsibilities will include the provision of technical operations support for the continuous improvement of packaging lines capacity and performance, and advisory of technical improvement projects. The role must ensure effective communication throughout the Amgen commercial site network with all partners and deliver on technical improvements.

Technical Lead

Technical expert lead for FDP combination and non-combination products. Manage new process equipment and technology. The candidate is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed.

The candidate will also be responsible for leading the Commissioning, Qualification and Validation of all process and GMP equipment located at AOH. They will own the site master validation plan for GMP equipment and will be responsible to the maintenance and execution of this.

Operational Excellence

Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the AOH site by analyzing, designing, and implementing manufacturing and business process improvements.

Relationships

Build a network of FDP expertise across the Amgen commercial and clinical operations for product assembly, label and packaging. The position is expected to leverage this network in support of GMP technical expertise, performance trending, equipment standardization and troubleshooting/process improvements at AOH.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree & 3years of Engineering experience

OR Master’s degree & 5years of Engineering experience

OR Bachelor’s degree or & 7 years of Engineering experience

OR Associate’s degree & 12 years of Engineering experience

OR High school diploma / GED & 14 years of Engineering experience.

Preferred Qualifications:

• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
• Proven track record of leading and executing cross-functional projects.
• Strong team work, excellent interpersonal and communication skills.
• Direct experience with the manufacturing process for combination products, assembly, label & packaging operations.
• Experience of working with Final Drug Product equipment suppliers.
• Ability to work in a highly regulated and ever changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast moving environment.
• An Operational Excellence approach to work product – driving rapid results.
• A passion to deliver an excellent work product and develop others with an infective positive attitude!

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 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, including remote and hybrid work arrangements, where possible

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

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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.

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Salary Range

168,903.00 USD - 197,453.00 USD