Process Development Sr Associate - Attribute Sciences
Process Development Sr Associate - Attribute Sciences
US - North Carolina - Holly Springs Apply NowJoin 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.
PROCESS DEVELOPMENT SR ASSOCIATE - ATTRIBUTE SCIENCES
What you will do
Let’s do this. Let’s change the world. In this vital role you will be part of Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development.
In this vital role, you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen’s FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting.
- Responsibilities include effectively delivering to the site, process development team, manufacturing and quality control through rapid and robust analytical testing.
- Ensure analytical support for small-scale model transfer, method transfers, investigation support, and continuous improvements.
- Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing.
- Understand analytical methodologies to detect product quality attributes and process-related impurities testing using a variety of techniques including but not limited to ELISA, qPCR and UV-Vis spectrophotometry.
- Execute methods, author reports and ensure safety and compliance for all activities.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a motivated, self-starter with these qualifications.
Basic Qualifications:
- High school diploma / GED and 6 years of related experience OR
- Associate’s degree and 4 years of related experience OR
- Bachelor’s degree and 2 years of related experience OR
- Master’s degree
Preferred Qualifications:
- Degree in Analytical Chemistry, Biochemistry, or related area.
- Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
- Strong experience in a variety of analytical techniques (i.e., ELISA, qPCR, SoloVPE).
- Experience in method transfers, method validation, method troubleshooting, and complex investigations.
- Solid understanding of GMP requirements and familiarity with USP monographs and chapters, as well ICH guidance documents related to analytical method transfer and validation.
- Knowledgeable in analytical method troubleshooting and analysis of product quality attributes related to biological processing.
- Strong communication skills and ability to interact effectively with diverse internal and cross-functional teams.
- Excellent technical writing skills, attention to details and compliance with GDP.
- Proven ability to work effectively in collaborative, team-based settings.
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.
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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.