Director Process Development - Commercial Attribute Sciences

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Process Development Director, Commercial Attribute Sciences

Live

What you will do

Lets do this. Lets change the world. In this vital role you will lead the Commercial Attribute Sciences group within the Process Development organization at Amgens new North Carolina facility. You will be accountable for serving every patient every time by providing scientific and technical analytical leadership to ensure high quality product for patients. The Commercial Attribute Sciences function is responsible for commercial analytical support, including activities such as method assessment, development, transfer, validation, investigations, and remediation activities.

• Responsible for providing scientific and technical analytical direction to support commercial drug substance production of biologics

• Support new product introduction, troubleshooting and improvement of existing and new processes run at the Amgen North Carolina Manufacturing site
• Assess initiatives from an attribute understanding perspective associated to process improvements and optimizations
• Responsible for the development and preparation of laboratory-based experiments to support small scale model interrogation, investigations, and process improvements.
• Supports and lead process, process safety and material risk assessment performed on-site
• Lead experimentation in the biologics lab to resolve analytical technical issues observed during transfer / manufacturing at large scale
• Responsible for ensuring collaborative leadership with site QC and the broader Attribute Sciences and QC networks

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The director level professional we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate Degree & 4 years of Process Development or Manufacturing Science Technologies experience OR
• Masters Degree & 8 years of Process Development or Manufacturing Science Technologies experience OR
• Bachelors Degree & 10 years of Process Development or Manufacturing Science Technologies experience AND
• 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• PhD in analytical, biological, or engineering sciences
• At least 8 years of relevant work experience in the commercial manufacturing environment within the biopharmaceutical industry
• At least 6 years experience with regulated environments (i.e. cGMP), and strong working knowledge of regulatory expectations related to analytical control strategies Familiarity with applicable worldwide regulatory requirements, and experience in authoring regulatory submissions
• Advanced experience in working closely with scientific and manufacturing disciplines across process development, clinical, and commercial operations
• Expert knowledge of analytical methods/technologies used in biologics manufacturing, and deep understanding of product quality attributes control strategies
• Expert understanding and hands-on experience of methods within the following platforms: Chromatography, Capillary techniques, ELISA techniques, and compendia assays supporting biologic manufacturing
• Expert understanding and hands-on experience with method transfer and method validation processes with direct experience from a Pharmaceutical or Biotechnology Company
• Familiarity and advanced experience in forensic investigations in support of manufacturing of biologics
• Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
• Experience collaborating and building solid working relationship across departments, with diverse and remote staff and with external collaborators
• Team leadership, management, and facilitation skills
• Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects
• Strong communication skills (technical writing and verbal communication/presentation)
• Ability to provide solutions to a large variety of technical problems

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

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 requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.