Back to Jobs

Director, Commercial Drug Products & Life Cycle Management

BioSpace
Cambridge, MA
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, Commercial Drug Products & Life Cycle Management

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 Product Technologies unit that continuously strives to be a technical leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team leaders (DPTLs) play a central role in this process by serving as single point of accountability for individual drug product programs for technical activities specific to formulation, aseptic drug product process design and validation, integrated development of combination products, process improvements, life cycle changes, regulatory submissions, annual product reviews, etc. DPTLs are part of an integrated operations team and lead a technical team responsible for delivering drug product process transfers, process optimization, process trouble shooting, timely closure of non-conformance investigations and change control assessments to ensure supply of commercial drug products. We are seeking a director to lead an impactful team of DPTLs responsible for all commercial drug product programs in our portfolio.

  • Provide scientific, technical and managerial leadership in support of commercial drug product and life cycle management activities.
  • Lead a team of highly skilled scientists and engineers with advanced degrees and training and lead the strategic direction of the group to ensure contract book deliverables for the portfolio, aware of industry trends, future requirements and feedback from key partners.
  • Provide technical leadership to influence and implement strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, biosimilars, and oral dosage forms.
  • Maintain strong partnerships with product delivery team leaders in Operations, Therapeutic Area heads, all Process Development groups, Regulatory, Quality and with Clinical and Commercial manufacturing sites to positively influence Amgen practices and strategies to ensure success through the life cycle of current and future commercial products.
  • Advance the organizations competence on GMP compliance, current regulatory trends and expectations.
  • Actively direct and lead team capacity/resources, budget targets, timelines.
  • Talent management responsibilities including hiring, leadership development, mentoring, training, and compliance to standard operating procedures, regulatory requirements, and quality systems in a GMP environment.
  • Recruit and retain technical staff that can deliver in a highly matrixed and dynamic environment.
  • Up to 25% travel to domestic and international sites.

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 experience in engineering, science, or business management

Or

Masters degree and 8 years of experience in engineering, science, or business management

Or

Bachelors degree and 10 years of experience in engineering, science, or business management

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 from an accredited college or university in one of the following areas: Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific subject area
  • 10+ years of pharmaceutical development and management experience
  • 10+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization
  • Demonstrated knowledge of drug product commercialization and integrated combination product development
  • Demonstrated experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at commercial sites
  • Strong knowledge about developing processes with single-use manufacturing equipment
  • Implements with a sense of purpose and drives course corrections where appropriate
  • Excellent written, verbal, and presentation skills - ability to distill, craft and present key messages relative to diverse audience requirements
  • Knowledge of applicable global regulatory requirements. Experience preparing technical sections of regulatory submissions and interacting with regulatory agencies on technical matters
  • Strong problem solving, trouble shooting, and communication skills
  • Ability to participate in global cross-functional teams and work effectively in a highly matrixed environment to lead change, efficiency, and strong cross functional relationships
  • Hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems
  • Superior knowledge of aseptic processing and manufacturing of injectable drugs in vials, syringes, cartridges, devices, disposables, and the associated GMP/Device documentation and regulatory filings
  • Experience with biologics and oral dosage form manufacturing is critical
  • Advanced understanding of primary containers (syringes, cartridges and vials), elastomer, polymer (injection and extrusion blow molding), formulation, technical modeling of complex systems, labeling and packaging, cold chain expertise
  • Strong focus on coaching, motivating and providing career and scientific/technical advice to staff
  • Strong networking skills to work across organizations to advance innovated processes, approaches and methodologies

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.

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.

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.
Posted 2025-10-27

Recommended Jobs

Production Team Partner - Garment Sorter & Shipper - UniFirst

UniFirst
Indian Orchard, MA

Our Production Team is Kind of a Big Deal! UniFirst is seeking a reliable and hardworking Production Team Partner to join our UniFirst Family. As a Team Partner in the Shipping Department, you will…

View Details
Posted 2025-10-15

Marketing Manager - Time Out Market Boston

Time Out Group Plc
Boston, MA

Title: Marketing Manager Location: Boston Department: Marketing Reporting to: General Manager / VP Marketing Brand Video: About the Role: Time Out Market is a global food and cult…

View Details
Posted 2025-09-29

Service Center Team Lead

River Run Services LLC
Newburyport, MA

Job Description Job Description Description: The Service Center Team Lead contributes to ongoing guidance of a team of Service Center Specialists, ensuring efficient daily operations and excel…

View Details
Posted 2025-10-19

Driver

ACOSTA TRANSPORTATION INC
Worcester, MA

Job Description Job Description # Se necesita choferes con experiencia de manejo de un 1

View Details
Posted 2025-07-28

ICU Physician Assistant / Nurse Practitioner

Boston Medical Center
Brockton, MA

Location:  Boston Medical Center - South Job Type:  Full Time Department:  ICU-Intensivist Prog Job Summary: Work as a part of a critical care team compromised of an Intensivist Physici…

View Details
Posted 2025-10-21

Senior engineer digital lab systems

Moderna, Inc.
Norwood, MA

The Role Moderna is seeking a Sr. Engineer- I who will serve a key role supporting the delivery and administration of laboratory systems. The individual will assist in the configuration and deploy…

View Details
Posted 2025-10-30

Host

O Ya Boston
Boston, MA

o ya restaurant is hiring a Host!  Our award-winning, contemporary Japanese restaurant in the Leather District, is hiring a host that would ideally work in the space 3-5 days per week. This is an o…

View Details
Posted 2025-09-08

Director

CSP Associates
Cambridge, MA

As a Director your role will include leading the execution of client strategic and transaction advisory engagements including, among other tasks: conducting primary research and analysis; structuring,…

View Details
Posted 2025-08-06

Account Manager, Americas (m/f/d)

FRAMOS
Massachusetts

ABOUT THE ROLE Are you a passionate sales professional with several years of experience within machine vision, industrial imaging, optics, robotics, and/or sensors and lasers? Do you live in the G…

View Details
Posted 2025-08-06