Process Development Principal Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Medical/Dental/Vision

Life and disability insurance

Flexible spending accounts

Annual bonus

Stock-based incentives

Paid time off

Flexible work models

Job summary

Amgen is seeking a Process Development Principal Scientist to lead drug product development strategies and cross-functional collaboration across teams. You will design and execute DOE studies to support late-stage and commercial programs, mentor scientists, and summarize findings for regulatory filings.

The role requires a PhD/PharmD/MD with substantial scientific experience or a Masters with 5+ years in the field, plus experience with organic chemistry and solid dosage form development.

Qualifications

• PhD/PharmD/MD with 2+ years scientific experience or Masters with 5+ years or Bachelors with 7+ years scientific experience.
• Pharmaceutical industry experience preferred; strong organic chemistry and materials science background.
• Experience mentoring and developing team members; exceptional technical writing skills.

Responsibilities

• Develop innovative strategies for drug product development and design and execute DOE studies to support late-stage and commercial programs.
• Lead Drug Product Teams (DPTL) and represent DP function on Product Development Teams to advance assets through formulation and process development.
• Collaborate across Amgen functions including Drug Substance Technologies, QA, Regulatory Affairs, Supply Chain, and Clinical Development.
• Mentor and supervise scientists; design and execute experiments; summarize results in regulatory filings and presentations.
• Engage with external groups and academic partners to advance development programs.

Skills

Leadership

Cross-functional collaboration

DOE studies

Technical writing

Mentoring

Project management

Analytical thinking

Education

PhD in Organic Chemistry / Pharmaceutical Sciences

PharmD / MD with scientific experience

Masters with 5+ years scientific experience

Bachelors with 7+ years scientific experience

Tools

XRPD

DSC

TGA

SEM

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Principal Scientist

What you will do

Lets do this. Lets change the world. In this vital role you will serve on the Drug Product Team (DPT), developing innovative functional area strategies and designing and executing DOE studies to support late stage and commercial programs.

• This Amgen leader will apply deep expertise in organic chemistry and their assemblies to develop innovative, fast-paced approaches as part of cross-functional teams.
• The Amgen DPT leader will lead Drug Product Teams as a DPTL and represent the DP function on Product Development Teams to advance late-stage assets through commercial formulation and process development, process characterization, marketing application, and post-launch commercial maintenance.
• The individual will collaborate effectively within DPT and across Amgen functions, including Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical Development, and Biostatistics.
• Will mentor and supervise scientists.
• Design and execute experiments to support drug product development objectives.
• Summarize results in technical documents, regulatory filings, and presentations.
• Engage proactively and effectively with external industry groups, such as the IQ Consortium, and academic partners, such as university consortia.
• Provide technical expertise on the structure, reactivity, and physicochemical properties of materials, including drug substances and excipients.

What We Expect Of You

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

Basic Qualifications

• Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience
• OR
• Masters degree and 5 years of Scientific experience
• OR
• Bachelors degree and 7 years of Scientific experience

Preferred Qualifications

• Ph.D. in a relevant scientific field, such as Organic Chemistry, Physical Chemistry, Chemical Engineering, Materials Science, or Pharmaceutical Sciences.
• Strong scientific foundation with deep understanding of organic molecules and their assemblies.
• Strong scientific acumen in organic chemistry, physical chemistry, solid-state chemistry, and the physicochemical properties of small molecules.
• Pharmaceutical industry experience, preferably with oral solid dosage forms.
• Proficiency with characterization techniques, including XRPD, DSC, TGA, SEM, and related methods.
• Knowledge of patent application processes and related legal frameworks is advantageous.
• Proven experience in authoring relevant sections for market applications and responding to questions from the agency.
• Experience mentoring and developing team members.
• Comprehensive understanding of unit operations used to manufacture oral solid dosage forms.
• Ability to design, execute, and complete independent formulation research.
• Demonstrated record of scientific publication and research dissemination.
• Proven ability to collaborate effectively across cross-functional teams.
• Exceptional technical writing skills with strong attention to detail.

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, well 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.

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.