Change Control Manager Jobs in Raleigh, NC (NOW HIRING)

Career Category
Quality
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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.
SR. MANAGER QUALITY CONTROL - CHEMISTRY
What you will do
Let's do this. Let's change the world. In this vital role you will lead teams responsible for the QC Chemistry laboratory and 1st and 2nd shift Quality Control operations. Responsibilities include the startup and validation of laboratory equipment, transfer and implementation of analytical methods, and development of a diverse team to support site startup and successfully transition into steady-state commercial operations at Amgen North Carolina.
Scope includes in-process, release, stability, characterization, and general analytical support for commercial manufacturing.
The Senior Manager, QC Chemistry & Operations will report directly to the Director of Quality Control and, as a member of the QC leadership team, will contribute to fostering and further developing a culture of Safety, Quality, collaboration, accountability, and Lean Leadership.

• Overall responsibility for startup, operational readiness, and day-to-day management of the QC Chemistry laboratory and oversight of 1st and 2nd shift QC teams, including successfully transitioning the organization from site startup activities into routine commercial operations.
• Lead QC Chemistry functions supporting analytical method families including chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and general compendial chemistry testing.
• Manage 1st and 2nd shift managers 7 days a week for cross functional night shift support for manufacturing.
• Ensure laboratory and shift operations are conducted in compliance with safety guidelines, cGLPs, cGMPs, and other applicable regulatory requirements.
• Build, lead, coach, and develop a high-performing organization capable of supporting both startup execution and long-term commercial manufacturing operations.
• Implement effective digital tools for leading the organization.
• Partner cross-functionally with Manufacturing, Process Development, Quality Assurance, Facilities & Engineering, Supply Chain, and other site functions to support startup readiness, process performance, and ongoing manufacturing operations.
• Participate in regulatory agency inspections and support site licensure and inspection readiness activities.
• Establish and drive Lean principles across all areas of responsibility to improve operational performance, reliability, efficiency, and compliance.
• Establish departmental goals, organizational strategies, staffing models, and KPIs to ensure successful execution of business objectives and sustainable 24/7 operational support.
• Interface with senior management on significant matters requiring coordination across organizational units and exercise independent judgment in decision-making.
• Translate complex technical and operational data into actionable insights and apply strong scientific and leadership knowledge to meet business objectives.
• Identify process gaps, implement innovative solutions, and lead operational excellence initiatives within the Amgen global QC network to improve efficiency, productivity, compliance, and cost effectiveness.

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Senior Manager Quality Control Chemistry professional we seek is a dynamic, resilient, and driven individual with these qualifications.
Basic Qualifications:

• High school diploma / GED and 12 years of Aseptic Manufacturing experience OR
• Associate's degree and 10 years of Aseptic Manufacturing experience OR
• Bachelor's degree and 8 years of Aseptic Manufacturing experience OR
• Master's degree and 6 years of Aseptic Manufacturing experience OR
• Doctorate degree and 2 years of Aseptic Manufacturing experience OR
  In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Experience working in a GMP pharmaceutical manufacturing environment with classified areas and applicable gowning requirements.
• Degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering, or related scientific field. Advanced degree preferred.
• Experience with QC analytical chemistry operations, including method transfer, qualification, validation, and routine testing in support of commercial biologics manufacturing.
• Strong technical expertise in analytical method families including chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and general chemistry techniques.
• Experience with laboratory startup activities, equipment qualification, and transitioning teams and systems from startup into commercial operations.
• Experience with analytical data trending, laboratory investigations, deviations, CAPAs, change controls, and regulatory documentation within a GMP environment.
• Experience supporting regulatory inspections and health authority interactions.
• Strong understanding of cGMPs, data integrity requirements, and quality systems applicable to pharmaceutical Quality Control laboratories.
• Strong written and verbal communication skills, including technical writing, data interpretation, and presentation of complex technical information to leadership and cross-functional teams.
• Demonstrated ability to work independently, lead cross-functional initiatives, manage multiple priorities, and develop high-performing teams in a fast-paced manufacturing environment.
• Experience establishing and driving Lean, continuous improvement, and operational excellence initiatives within a QC organization.

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, 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.
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.
Salary Range
142,103.85USD -192,258.15 USD