Director, Small Molecule 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 awardwinning 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 Small Molecule Process Development

What you will do

Lets do this. Lets change the world. In this vital role you will be part of Amgens Process Development organization Drug Substance Technologies Synthetics (DSTS) plays a vital role in developing robust drug substance manufacturing processes to serve patients. Specifically DSTS is an integrated organization of small molecule process chemists and engineers that is accountable to invent develop and deploy drug substance manufacturing processes and technologies to advance Amgens synthetic and hybrid portfolio. In this role the Director is responsible for leading a team of process chemists that drive all aspects of commercial process development process design process characterization site selection for commercial manufacturing and technology transfer for our synthetic portfolio inclusive of hybrid modalities (e.g. peptides oligonucleotides and bioconjugates).

This is an onsite role based out of our Amgen Thousand Oaks CA headquarters and reports to the Senior Director of Process Development.

• Accountable for leading a team of process chemists ensuring that the DSTS mission and vision are implemented and upheld

• Accountable to advance a complex and diverse synthetics portfolio of molecules including small molecules bioconjugates ADCs peptides and oligonucleotides from research through to commercialization working with our partners across Operations and our internal and external manufacturing network

• Effectively manage performance and career development for staff and develop the next generation of leaders from within the department

• Directly responsible for departmentwide activities (e.g. budgeting capital allocation project assignment alignment initiatives setting vision/direction/strategy and technology development)

• Ensures that industry standards and best practices that fit Amgens business needs are effectively applied

• Represents Drug Substance Technologies as a scientific regulatory and technical expert both internally and externally

• Evaluates resolves and/or escalates issues in a timely manner

• Serves as a technical expert in small molecule and hybrid modalities and keeps current in drug substance development including literature and technology development for cutting edge and regulatory driven activities

• Understands the technical and/or scientific capabilities of the department and provides guidance to all junior and senior staff members to resolve scientific/technical issues

• Conveys a broader level of understanding in pharmaceutical R&D and commercialization to the department

• Extensive knowledge of GLP and GMP activities

• Clearly understands and applies knowledge of regulatory requirements (FDA ICH USP etc.) to completion of projects

• Leads and/or participates in technical forums for sharing of best practices and application of scientific expertise

• Oversees and upholds proper safety practices

• Provides oversight for pipeline projects through their experience and leadership in scientific technical and regulatory issues

• Leads by example: Creative hardworking responsive flexible and with a demonstrated willingness to adjust in a landscape of constantly changing program outcomes and priorities

• Aligns project resources with program status projected activities and organizational prioritization.

• Ensures that effective teams are built and sustained within the department

• Facilitates cohesiveness fosters engagement and builds team spirit

• Provides feedback through coaching and effective performance appraisal and development planning

• Initiates and encourages scientific discourse and effective collaboration with groups outside the department

• Anticipates proactively detects and addresses problems related to departmental and inter departmental activities

• Communicates effectively with others using appropriate diplomacy sensitivity and confidentiality where required

• Establishes and maintains effective communication mechanisms to keep staff appropriately informed

• Bridges communication between individuals units and other organizations as necessary

• Informs and consults management and senior leaders appropriately

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 and 4 years of Scientific Process Development and/or Technical Service experience

Or

• Masters degree and 8 years of Scientific Process Development and/or Technical Service experience

Or

• Bachelors degree and 10 years of Scientific Process Development and/or Technical Service experience and

• 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 above

Preferred Qualifications:

• PhD with 10 years of relevant experience in the pharmaceutical or related industry which includes leadership of scientific project teams and successful leadership of drug substance project groups

• Excellent knowledge of synthetic organic chemistry chemical process development process characterization and validation and technology transfer

• Excellent technical communication skills both written and verbal to interact effectively with all stakeholders

• Strong problemsolving skills including application of scientific theory

• Strong experience with regulatory requirements for API/Product (CMC for IND/NDA GLP/GMP ICH)

• Experience in authoring briefing books investigational new drug applications marketing authorization applications and responses to regulatory questions

• Wellrecognized and established in the scientific community through a record of peerreviewed publications and/or patents

• Demonstrated success developing staff including effective feedback and coaching

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 wellbeing. 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 salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff 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 ageidentifying 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.

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.

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