Specialist Contract Development & Manufacturing

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.

Specialist Contract Development & Manufacturing

What you will do

Lets do this! Lets change the world!

Provide information insight and data analysis drive execution of transactional/tactical tasks to ensure performance execution across the external manufacturing network.

• Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development monitoring and reporting; inputs to contracts confidentiality disclosure agreement(s) scope of work agreement(s) request for pricing/information supply agreement(s) etc. Own NC Minor/MajorI records CAPA CAPA EV and more complex change control records.

• Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination issuance and review of meeting minutes conclusions from analysis of data and metrics continuous improvement and standardization of performance tools used by the Work Center Teams (WCT) oversight and reporting of procurement/payment of invoices and active participation in WCT meetings with the contract site as well as internal site team.

• Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide critical issue to the right level.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborator with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Manufacturing experience OR

• Associates degree and 8 years of Manufacturing experience OR

• Bachelors degree and 4 years of Manufacturing experience OR

• Masters degree and 2 years of Manufacturing experience OR

• Doctorate degree

Preferred Qualifications:

• Bachelors in Business Administration Engineering or Science-related field.

• 5 years of experience in protein API DS DP or packaging manufacturing environment.

• 5 years in roles requiring knowledge of cGMP principles FDA and other regulatory guidelines and validation principles.

• 2 years of project management experience leading multi-functional and/or multi-location team.

• 1 years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products.

• Manufacturing and cGMP knowledge / experience.

• Financial knowledge and business acumen.

• Budget management including purchase orders financial forecasting and adhering to financial targets and systems.

• Demonstrated matrix management and influencing skills.

• Demonstrated negotiation skills.

• Operational Excellence proficiency and ability to drive continuous improvement.

• Proficient project management skills.

• Problem-solving and critical thinking.

• Understanding of contractual requirements.

• Technical writing and multi-level communication skills.

• Demonstrated ability to lead effectively in collaborative/team environment.

• Demonstrated ability to take initiative drive action and work under minimum supervision.

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.

Salary Range