Process Development Director
Amgen is seeking a Process Development Director to be based in our office in Cambridge, MA. The Director will report to the Executive Director of Process Development.
The Process Development Director will provide scientific, technical and managerial leadership in support of pivotal drug product development. The Director will also manage a team of process and formulation experts and will contribute to the strategic direction of the group, based on industry trends, future requirements and feedback from key partners. Based on future needs, the Incumbent will help direct scientific and technology investments to enhance Amgen's ability to advance drug product development.
Scope of the Group:
- Commercial formulation and process development
- Technology transfer to clinical manufacturing and process characterization
- Technology transfer to commercial manufacturing and marketing application authoring and response to questions
- Lifecycle management presentations for commercial products and evaluate, develop, and implement novel technology that can increase throughout and capacity and/or reducing development cycle time
- Generation, maintenance and application of platform formulations and processes as well as intellectual property considerations
Responsibilities of the Process Development Director include:
- Leads a high performing technical team with diverse scientific disciplines
- Effectively interfaces with partners in Process Development, Quality, Regulatory and Manufacturing to ensure optimum drug product development
- Takes a proactive role in developing and applying new approaches; demonstrates creativity in solving complex technical problems
- Provides leadership in developing strategy and experimental plan to enable drug delivery that maximizes biological efficacy, ease of administration and intended product presentation as well as oversight and direction for individuals and teams responsible for developing formulations and processes for multiple programs and therapeutic areas
- Organizes and leverage resources to maximize output while still being very innovative
- Develops and disseminate department vision and goals and connects each team members' work with the bigger picture
- Provides input to the development of program strategy, budgets, timelines and project plans. Ensures technical and business requirements are managed and met
- Deals with ambiguity and a rapidly changing environment; while easily shifting gears as needed and bring the team along
- Guides and mentor others on day to day performance, long term career development and through change.
- Well versed in process engineering, pharmaceutical sciences, formulation development and/or drug delivery technologies and can advocate for approaches related to drug administration
- Regularly interacts with senior management and executives to create broad-based departmental direction
- Contributes to regulatory filings including IND's and MA's; as needed assists in answering questions from regulatory authorities.
- Rigorously reviews of all department scientific and regulatory deliverables
- Effectively manages a cross-site (Thousand Oaks, CA and Cambridge, MA) department
Doctorate degree and 4 years of Process Development experience
Master's degree and 8 years of Process Development experience
Bachelor's degree and 10 years of Process Development experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- A Doctorate in one of the following areas: Biology, Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific discipline
- 14 years of pharmaceutical development and 10 years of management experience
- 12 years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization.
- Demonstrated knowledge of drug stability assessment and mitigation strategies
- Demonstrates courage in all of his/her interactions: excels at asking the tough questions, can take the heat and can make difficult decisions
- 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
- 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 and experience preparing technical sections of regulatory submissions and interacting with regulatory agencies on technical matters