Senior Manager Process Development - Drug Product
Amgen
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Process DevelopmentJob 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-basedthe . 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.
Senior Manager Process Development – Drug Product
What you will do
Let’s do this. Let’s change the world! In this vital role, you will direct activities of the AML-14 Drug Product (DP) Process Development (PD) Organization. The position will lead an organization of scientists and engineers to improve existing processes as well as implement new products and technologies at the highest quality level and on time to meet our patient’s needs.
Specific responsibilities include but are not limited to:
- Plan, coordinate, and implement technical service activities which include new product introductions, process improvements, validations, etc.
- Interface with plant managers, i.e., production managers and senior process development staff to assess needs and update progress.
- Provides guidance to subordinates based on departmental/site goals and company policy.
- Work is reviewed in terms of meeting functional objectives and schedules.
- Determines and pursues courses of action necessary to obtain desired functional results.
- Responsible for all projects assigned to the applicable functional organization.
- Directly participates in establishing and administering many centralized departmental projects.
- Develop goals and objectives for the group and provide technical guidance to them.
- Make budget recommendations and oversee expenditures.
- Supervise staff, providing performance appraisals, hiring, and handling staff relations issues.
- Provide day to day commercial support to parenteral drug product formulation and filling process, including deviations, process monitoring assessment, regulatory inspections, etc.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Senior Manager Process Development professional we seek is a collaborative leader with these qualifications.
Basic Qualifications:
Doctorate degree & 2 years of Process Development, Quality and/or Manufacturing support experience
Or
Master’s degree & 6 years of Process Development, Quality and/or direct Manufacturing support industry experience
Or
Bachelor’s degree & 8 years of Process Development, Quality and/or direct Manufacturing support industry experience
Or
Associate’s degree and 10 years of Process Development, Quality and/or direct Manufacturing support industry experience
Or
High school diploma / GED and 12 years of Process Development, Quality and/or direct Manufacturing support industry experience
And
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.
Beyond that, additional preferred qualifications are:
- Educational background in Life Science and/or Engineering.
- Experience directly supporting Drug Product manufacturing operations.
- People leadership experience directly with resource allocations and managing technical groups.
- Solid written and verbal communication skills in English.
- Experience working with multiple functional areas with the ability to connect with several business partners and clients.
- Strong organizational skills with the ability to prioritize efforts and delegate resources with multi-task project expertise.
- Advanced scientific analysis and process characterization experience.
- Experience with equipment commissioning and qualification, validation, and documentation processes in a highly regulated environment.
- Strong knowledge of statistics and proficiency in statistical software such as JMP and/or Minitab
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.
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 & vision coverage, and life & disability insurance
- 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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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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