Director, Commercial Drug Products & Life Cycle Management
- Employer
- Amgen
- Location
- Cambridge, MA, US
- Start date
- Jul 22, 2019
View more
- Discipline
- Marketing, Product Development/Management, Science/R&D, Pharmacology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
JOB RESPONSIBILITIES:
The director of this team will provide scientific, technical and managerial leadership in support of commercial drug product and life cycle management activities. She/he will manage a team of highly skilled scientists and engineers with advanced degrees and training and will contribute to 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. The primary focus of this group is to provide technical leadership to influence and execute strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, biosimilars, and oral dosage forms. As a key contributor to Amgen's commercialization process, the director must 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. Actively direct and manage team capacity/resources, budget targets, timelines, etc. Advance organization's acumen on GMP compliance, current regulatory trends and expectations. Fulfill talent management responsibilities for technical personnel including hiring, leadership development, mentoring, training, and compliance to standard operating procedures, regulatory requirements, and quality systems in a GMP environment. Recruit and retain highly capable staff that can deliver in a highly matrixed and dynamic environment.
This position requires (up to 25%) travel to domestic and international sites
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
4 years of managerial experience directly managing people and/or leadership experience leading commercial teams, high impact initiatives, programs and directing the allocation of resources.
PREFERRED QUALIFICATIONS:
- A Doctorate (Ph.D.) 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 discipline
- 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
- Executes 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
- Established 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 team environment to drive 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 essential
- 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
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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, or disability status.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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