Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)

BioSpace; Thousand Oaks (CA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Comprehensive benefits

Annual bonus

Stock options

Time-off plans

Flexible work model

Job summary

Amgen is seeking a Senior Director to lead Process Engineering within the Drug Substance Technologies Synthetics group. You will drive technical solutions for development, characterization, technology transfer, and lifecycle management of synthetic and hybrid drug substances for early and late-phase programs.

You will lead a global team of 30+ scientists and engineers, shaping strategy, collaboration with cross-functional teams, and ensuring safety, quality, and regulatory compliance across

Qualifications

• PhD in chemical engineering or related discipline required.
• Minimum 5 years of scientific process development leadership.
• Experience managing teams of 20+ staff.
• Experience with IND/MAA filings.
• Strong cross-functional collaboration skills.

Responsibilities

• Lead a global organization with accountability for process engineering capability and talent development.
• Provide strategic oversight for synthetic & hybrid portfolio from early-phase to commercial.
• Oversee technology transfer, process characterization, and lifecycle management.
• Author and review global regulatory filings and responses to questions.
• Ensure safety, quality, and compliance across SOPs and operations.
• Recruit, develop, and retain a high-performing, diverse team.
• Manage portfolio prioritization, resource allocation, and budget.
• Collaborate with CDMOs and external partners for tech transfer and scale-up.

Skills

Leadership

Regulatory filings

IND/MAA submissions

Process development

Budget management

Cross-functional leadership

Education

PhD in Chemical Engineering or related

MS in Chemical Engineering or related

BS in Chemical Engineering or related

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.

Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)

What You Will Do

Lets do this. Lets change the world. Would you like to lead a highly motivated team of process development experts and professionals to positively impact patients lives? Amgen is seeking a Senior Director to serve as our Head of Process Engineering within the Drug Substance Technologies Synthetics (DSTS) organization. In this role, the Senior Director will be a member of the DSTS Leadership Team and be accountable to drive technical and strategic solutions for the development, characterization, technology transfer, and lifecycle management of synthetic and hybrid drug substance manufacturing processes for our early- and late-phase clinical and commercial portfolios. In this on-site role located in either Cambridge, MA or Thousand Oaks, CA you will lead and develop a global, multisite organization of 30+ scientists and engineers, provide strategic oversite to ensure program success, and foster a culture of safety, quality, compliance, and technical excellence. In addition, you will represent the DSTS organization in our cross functional collaborations to ensure the successful implementation and performance of our clinical/commercial drugs substance manufacturing processes.

Key Responsibilities

• Lead a global organization with accountability for the capability of our small molecule/hybrid process engineering team, talent development, succession planning, performance management, and fostering a culture of innovation, collaboration, and operational excellence.
• Provide strategic oversight for the advancement of our synthetic & hybrid portfolio from early-phase clinical through commercial advancement and lifecycle management.
• Establish and implement improved engineering business and technology platforms from early-phase through commercial process development, process characterization, lifecycle management, and technology transfer.
• Strengthen the technical capabilities and innovative practices across the engineering organization.
• Author and review global regulatory filings (IND/INDa/MAA) and responses to regulatory agency questions.
• Foster a culture of safety, quality, and compliance while ensuring adherence to standard operating procedures.
• Recruit, develop, and retain a high-performing and diverse team.
• Manage portfolio prioritization, resource allocation, and budget.
• Partner with manufacturing and external network collaborators to enable successful process technology transfer, validation and clinical/commercial supply.
• Engage directly with the leadership and technical teams of our external partners and contract development & manufacturing organization (CDMOs).
• Drive ideation, development, and deployment of innovative and differentiating technologies that decrease development time and create more robustness and cost-effective processes.
• Identify process improvement opportunities to increase robustness and reduce cost over the lifecycle of commercial drug substance processes.
• Contribute to Amgens scientific eminence through publications, patents, and participation in external conferences and forums.
• Serve as a member of the Drug Substance Technology Synthetics Leadership Team and contribute to business, organizational, and changemanagement strategies.

Travel Requirements

• May require approximately 10-20% travel (domestic and international).

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 5 years of scientific process development experience, OR
• Masters degree and 9 years of scientific process development experience, OR
• Bachelors degree and 11 years of scientific process development experience, AND

In addition to meeting at least one of the above requirements, you must have at least 5 years of experience directly managing people and/or organizational leadership experience leading teams, projects, or programs. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications

• PhD in Chemical Engineering or related discipline.
• 10+ years of experience in synthetic/hybrid pharmaceutical process development.
• Minimum of 5 years of experience directly managing people and managing an organization of >20 staff members.
• Subject matter expert in small molecule, peptide, oligonucleotide, and/or bioconjugate process development within the pharmaceutical industry.
• Expertise in cGMP operations, technology transfer, scale-up, and commercialization of active pharmaceutical ingredients.
• Experience managing technology transfer and manufacturing at contract manufacturing organizations (CMOs).
• Experience with quality risk management processes.
• Working knowledge of pertinent regulatory and ICH guidance.
• Experience with drafting regulatory filings (IND, MAA), annual product reviews (APR), briefing documents, and responses to regulatory questions.
• Fluency in synthetic and hybrid drug substance development including process design, optimization, characterization, validation (PPQ).
• Proven ability to provide scientific and engineering leadership on complex crossfunctional programs.
• Demonstrated experience in statistical data analysis, technical decisionmaking, and quality by design principles.
• Experience with executive-level communication.
• Track record of developing talent through coaching, mentoring, and feedback.
• Active engagement in the scientific community (publications, patents, industry forums).

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.

careers.amgen.com

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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.

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.