Director Process Development - Drug Substance Technologies

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.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainlesssteel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best inclass drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbonneutral company by 2027.

Director Process Development Drug Substance Technologies

What you will do

Lets do this. Lets change the world. In this vital role you will lead Amgens commercial phase drug substance team for Amgens North Carolina Site (ANC). Responsible for scientific and technical leadership of Drug Substance (DS) manufacturing processes and technologies. Oversight responsibilities span commercialization through full scale process validation and lifecycle management of processes implemented by Amgens North Carolina operations. You will also work in close collaboration with Manufacturing Engineering and Quality functions to enable progressive improvements in commercial processes. You will have direct responsibility for establishing a team of scientists/engineers to support a growing capability in a new site. Reporting to the ANC Site PD Lead Executive Director of Drug Substance Technologies.

• Responsible for all drug substance technology and partnership with leaders in PD for process transfer to/from the site
• Deliver CMC authoring activities for products at the ANC site
• Provide oversight of all process monitoring activities (real time multivariate statistical process monitoring)
• Drive life cycle improvements in commercial process
• Assure manufacturing operations are aligned with the registered process
• Provide oversight and support for technical investigations
• Ensure safety and compliance of process development activities
• Set goals and priorities allocating resources monitoring project progress and managing the organizations budget
• Provide oversight and leadership of innovation and manufacturing technology advancements and implementation at the site
• Lead crossfunctional teams to resolve complex problems while meeting quality schedule and cost objectives.
• Serve as member of the Drug Substance Technology (DST) extended leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities
• Ability to travel as needed

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 collaborative partner with these qualifications.

Basic Qualifications:

• Doctorate degree and 4 years of Process Development Engineering or Manufacturing experience

Or

• Masters degree and 8 years of Process Development Engineering or Manufacturing experience

Or

• Bachelors degree and 10 years of Process Development Engineering or Manufacturing 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 of resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• PhD in Chemistry Biochemistry Biochemical or Chemical Engineering
• 10 years of experience in pharmaceutical/biopharmaceutical process development or commercial cell culture process support in a current Good Manufacturing Practices (cGMP) environment and global regulatory expectations
• 5 years of managerial experience in a cGMP environment.
• Ability to identify and build a successful team that demonstrates Amgen Values and delivers results.
• Strong technical understanding of at least one area of drug substance bioprocessing upstream or downstream and able to direct aspects of area where one is not a subject matter authority
• Ability to compile and statistically analyze data draw appropriate conclusions and make presentations to crossfunctional audience and senior management
• Proven skills in negotiation conflict resolution and managing customer expectations
• Direct experience supporting commercial biopharmaceutical process development
• Detailed understanding of all stages of Process Validation lifecycle in biologics: Process Design PPQ Continuous Process Validation (CPV)
• Demonstrated ability in providing engineering expertise to crossfunctional teams Manufacturing Quality and Supply chain to advance complex projects to completion and to interface on technical problem resolution
• Understanding of quality attributes of protein products and analytical methods for determination of these attributes
• Knowledge and understanding of software tools for modeling of fluid flow mixing mass and energy balance and facility utilization
• Experience in authoring marketing authorization applications
• Wellrecognized in the scientific community through a record of peerreviewed publications and/or patents or active in industry forums and conferences.
• Demonstrated success developing staff including effective feedback and coaching
• Demonstrated collaborative experience and ability to effectively work through others
• Strong understanding of cGMP and global regulatory expectations

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.

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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.

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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