Director, Process Development
vor 2 Wochen
The Director, Process Development manages a large team of scientists, supervisors and managers that are assigned to a more than one functional area and/or site. Responsible for overseeing the global alignment, strategic growth and continuous improvement of their department to align with long term strategy of the business unit and company. Accountable for the profit and loss (P&L) of their department, and effectively managing resources through a sales and operational planning (S&OP) process. Identifies, develops, and validates new scientific methodologies on highly critical, unique and complex projects which align with the overall company strategy. Plans and manages significant technical/scientific project activities to execute strategies and technical solutions that meet client’s needs and expectations through broad expertise.
**Key Responsibilities**:
- Provides leadership to process development team, upstream process development and downstream process development.
- Provides guidance to project teams leads, program managers and the leadership team members; can act as a project team lead as needed.
- With strong biologics process development and process characterization knowledge, able to leads technical discussions with clients with a high level of technical proficiency.
- Accountable for developing upstream cell culture processes and systems, harvest processes, and downstream processes that meet internal customers (operations and/or QCs) needs and aligning those process across the biologics network.
- Partners with MSAT, quality and operations to ensure roles and responsibilities are defined appropriately for their department(s) and other departments onsite and within the network.
- Serves as a consultant and technical expert to executive management.
- Leads high-level design of major experimental plans.
- Conducts highly complex analyses to support process development. Works with Process Development and Manufacture groups to trouble-shoot process challenges.
- Sets guidelines for recording of results and reviews documentation by others.
- Oversees preparation of protocols, reports, test methods, and SOPs.
- Maintains and ensures safe laboratory environment and work practices.
- Remains current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences as well as researching and publishing papers.
- Knowledge and expertise may be leveraged throughout organization and not limited to site.
- Plans project scope, timing and resource requirements.
- Acts as technical lead on multiple programs, with responsibility for running those programs.
- Collaborates with Program Management to ensure clear expectations and successful deliverables.
- Serves as primary contact with clients and provides regular communication of data and status.
- Leads relevant program team meetings. Trains and mentors less experienced Scientists and provides technical leadership.
**Qualifications**:
- Bachelor’s degree required in biology, chemistry, biochemistry, chemical engineering or related field. Master’s Degree or PhD preferred.
- Minimal of 18 years related to pharmaceutical manufacturing, process development or academic laboratory and at least 10 years of relevant industry experience.
- Advanced and deep knowledge of biologics process development principles, concepts, and practices in discipline, known as a SME in that discipline, and good knowledge of principles and concepts of other relevant disciplines.
- Thorough knowledge of regulatory issues and the impacts on discipline. Strong knowledge of general cGLP procedures and those specific to discipline. Strong knowledge of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment.
- Demonstrated leadership skills and experience managing a team of Scientists and Engineers.
- Expertise in functional area recognized throughout entire organization.
- Excellent problem solving and critical thinking skills.
- Excellent writing, communication and presentation skills.
- Strong MS Excel, PowerPoint and Word skills. Microsoft Project skills preferred.
- Excellent organization and planning skills.
- Strong attention to details and ability to adhere to standards procedures.
- Ability to drive functional, technical and operational excellence.
- Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
- Ability to design complex studies based on the deliverables.
- Ability to analyze and summarize complex scientific data.
- Ability to author reports, procedures, and other documents.
- Ability to function in a rapidly changing environment.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to make and communicate complex decisions.
- Ability to perform all process steps and to guide manufacturing on the operation of all process steps.
- Ability to speak effectively before groups
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