Director Process Development

Career Category

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. 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.

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 ofpharmaceutical experience
OR
Masters degree and 8 years of pharmaceutical experience
OR
Bachelors degree and 10 years ofpharmaceutical 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 Amgens 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 companys 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 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 including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

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.

Salary Range