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In this vital role you will be part of Amgen’s 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.
Job Responsibility:
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
Requirements:
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 or resources
Nice to have:
PhD from an accredited college or university in 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
Excellent written, verbal, and presentation skills
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 we offer:
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
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