Manager Manufacturing, Single Use Systems & Validation

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.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Manager Manufacturing Single Use Systems & Validation

What you will do

Lets do this. Lets change the this vital role you will act as the Manager for the Single Use Systems and Cleaning Validation Team in our GMP Drug Substance Manufacturing facility. This position is within Amgen North Carolina (ANC) Drug Substance FlexBatch Manufacturing facility in the- Manufacturing Support organization.

ANC is a dynamic environment and an important supply facility for Amgens pipeline products. The GMP FlexBatch plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment this vital role you will act as the Manager for Single Use Systems and Cleaning Validation leading a team responsible for the oversight implementation and continuous improvement of single use technologies and equipment cleaning validation strategies in GMP manufacturing. You will be a key technical and communication interface between manufacturing operations process development engineering supply chain and quality.

• Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area.
• Oversee development implementation and maintenance of SOPs training materials and Quality Management System records related to Single Use Systems and equipment cleaning validation.
• Lead development and execution of the sites Cleaning Validation Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers) validation plans equipment qualification protocols/reports and cleaning validation strategies.
• Manage and mentor a team of specialists and engineers including hiring training performance evaluations and development.
• Coordinate troubleshooting and support during commissioning qualification start-up and process performance qualification of the facility.
• Facilitate process area and equipment risk assessments to identify risks failure modes and mitigating actions.
• Ensure compliance with regulatory requirements support regulatory submissions audits and inspections.
• Champion Lean Transformation and operational excellence initiatives driving continuous improvement in the plant.
• Collaborate cross-functionally with Manufacturing Engineering Quality Supply Chain and Process Development to ensure alignment and readiness for new products process changes and advanced technologies.
• Develop and implement training plans and programs to ensure staff are prepared and compliant.
• Maintain inspection readiness and support 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 professional we seek will possess these qualifications.

Basic Qualifications:

• High school diploma/GED and 12 years of biotechnology operations or validation experience OR
• Associates degree and 10 years of biotechnology operations or validation experience OR
• Bachelors degree and 5 years of biotechnology operations or validation experience OR
• Masters degree and 3 years of biotechnology operations or validation experience OR
• Doctorate degree

Preferred Qualifications:

• Educational background in Chemical Engineering Industrial Engineering Biology Biochemistry Life Sciences or related field.
• Experience leading/managing a team of direct reports in a GMP manufacturing environment.
• Strong technical knowledge of Single Use Systems and Cleaning Validation strategies for biologics manufacturing.
• Experience in supporting regulatory submissions audits and inspections.
• Proficient technical writing and presentation skills to communicate complex information effectively with technical and senior management staff.
• Experience in cross-functional project management and operational excellence initiatives.
• Ability to coach mentor and cross-train colleagues within core technical areas.
• Background in lean manufacturing methodologies and continuous improvement.
• Knowledge of relevant regulations (e.g. FDA Title 21 CFR Part 210/211 Eudralex Annex 15 ASTM E2500 ICH Q7).

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.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

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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