Process Development Senior Scientist – Analytical Development

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.

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 Senior Scientist – Analytical Development**

**What you will do**

Let’s do this! Let’s change the world!

In this vital role you will be joining our Pivotal Attribute Sciences Department in Thousand Oaks, CA.

This group is responsible for late phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of late phase drug substances and drug products.

The Scientist will work closely with a team of analytical chemists, organic chemists, and formulation scientists responsible for the technical aspects of developing the analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic programs.

The Scientist will integrate and successfully utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application.

**Key Responsibilities:**

+ Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs.
+ Develop, optimize, and authorize analytical methods for synthetic molecules release testing and characterization
+ Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives
+ Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry
+ Manage activities at contract manufacturing and testing sites.
+ May lead method transfer to CMO or contract testing labs
+ Review and approve protocols, reports from CMO and contract testing labs
+ Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
+ May lead and develop a small group of scientists.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients.

The analytical professional we seek is an emerging Scientist with these qualifications.

**Basic Qualifications:**

+ Bachelor’s degree and 5 years of Scientific experience OR
+ Master’s degree and 3 years of Scientific experience OR
+ Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]

**Preferred Qualifications:**

+ PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
+ 2+ year’s post-PhD experience in the pharmaceutical or biotech industry in process development and drug substance, drug product analytical method development.
+ Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry.
+ Strong experience in liquid chromatographic and mass spectroscopic analysis
+ Experience in a wide variety of structure elucidation and physicochemical techniques including MS, NMR, UV, FTIR etc.
+ Developing and implementing methods for in-process testing, release and stability testing.
+ Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
+ Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
+ Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines
+ Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile Works well in cross-functional teams, and across various geographic locations in different time zones
+ Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents

**What you can expect from 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, including remote and hybrid work arrangements, where possible

**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.

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.

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.

Required Skill Profession

Other General