Amgen · 3 months ago
Director, Commercial Drug Products & Life Cycle Management
Cambridge, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
4+ years expAmgen is a leading biotechnology company dedicated to serving patients with serious illnesses through innovative medicines. The Director of Commercial Drug Products & Life Cycle Management will provide scientific and managerial leadership, overseeing a team responsible for drug product programs, ensuring compliance, and advancing the organization's capabilities in drug product commercialization.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
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 organization’s 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
Qualification
Required
Doctorate degree and 4 years of experience in engineering, science, or business management
Masters degree and 8 years of experience in engineering, science, or business management
Bachelors degree and 10 years of experience in engineering, science, or business management
At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Preferred
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
Benefits
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
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-16
Pharmaceutical Technology
2026-01-16
2026-01-16
Company data provided by crunchbase