Director Process Development
Director Process Development
US - California - Thousand Oaks APLICAR AHORAJoin 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.
Director Process Development
What you will do
The Director of Process Development will serve as the Similarity Lead, driving cross-functional teams in the development of multiple biosimilar products from pre-clinical through commercial stages. This role is responsible for developing and executing strategies for analytical and nonclinical similarity assessments, supporting regulatory approval and commercial success for Amgen biosimilar products. The Director will collaborate with internal and external stakeholders, providing scientific, business, and tactical leadership.
Key Responsibilities
Lead the development and execution of analytical and nonclinical similarity assessment strategies, including biological, biochemical, and biophysical characterization, in accordance with current regulatory guidance.
Oversee cross-functional collaboration with Research Therapeutic Discovery, Translational & Safety Pharmacology, Clinical Development, Process Development, Quality, Manufacturing, Regulatory, Legal, and Commercial teams.
Guide process development to achieve similarity, leveraging expertise in structure-function relationships and risk ranking of quality attributes.
Provide scientific leadership in characterizing biochemical, biophysical, and functional properties of antibodies and recombinant proteins.
Design and implement in vitro pharmacology study plans to demonstrate nonclinical similarity.
Advise on statistical analysis and graphical presentation approaches for regulatory submissions, including briefing documents and dossiers.
Author and review analytical similarity sections for regulatory submissions throughout the product lifecycle (briefing books, INDs, amendments, marketing applications).
Lead responses to scientific questions from global regulatory agencies.
Collaborate with internal and external partners, including contract labs, to support analytical development.
Contribute to biosimilar publication plans and external scientific communications (oral presentations, posters, articles).
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 go-getter with these qualifications.
Basic Qualifications:
Doctorate degree and 4 years of pharmaceutical experience
OR
Master’s degree and 8 years of pharmaceutical experience
OR
Bachelor’s degree and 10 years of pharmaceutical experience
In addition to meeting at least one of the above requirements, you must have at least 4 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced abov
Preferred Qualifications:
Advanced degree (Ph.D., Pharm.D., or equivalent) in Chemistry, Biochemistry, Biology, or related field.
Extensive experience in process development within the pharmaceutical or biotechnology industry, with a focus on biosimilars.
Demonstrated expertise in analytical sciences, structure-function characterization, nonclinical pharmacology, regulatory submissions, and cross-functional leadership.
Strong knowledge of FDA, EMA, and global biosimilar regulatory requirements.
Excellent communication, collaboration, and project management skills.
Proven ability to mentor and lead scientific teams.
Additional Information
This position is critical to Amgen’s biosimilar strategy and requires a leader who is comfortable working in a dynamic, collaborative environment. The successful candidate will be expected to interface with broad cross-disciplinary business functions and external partners, contribute to strategic decision for Amgen biosimilar business unit, and support the company’s mission to deliver high-quality biosimilar products.
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, 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.
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 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.