Senior Scientist (AZ15466)
Senior Drug Product Technlogy Steward (contractor) role within Global Technical Operations is accountable for commercial drug product technology transfer and technical support. The position is a corporate global role, to be based in Gaithersburg, Maryland. The person will work closely with drug product development group to ensure smooth and seamless transfer of drug product pipeline and commercial projects.
Essential Job Functions:
- Manage drug product technical transfer projects and support life cycle technical support of drug products across manufacturing sites.
- To support complex drug product transfers, technical commercial scale-up, process validation and lifecycle technical support of drug products.
- To proactively provide expert technical and scientific contributions from a manufacturing operations point of view, which impacts and influences the drug products successful commercialization.
- To provide indirect scientific or technical guidance and leadership to Engineers and Technicians to enable them to optimally meet their project objectives.
- The role requires strong technical skills alongside project management, influential and innovation skills, and a thorough understanding of drug products processes, change- and risk management principles and regulatory requirements for drug products commercialization.
- Management of continuous improvement projects, design changes and lifecycle management of on market products, including but not limited to leading impact assessments and action plans.
- Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. QSR/ISO/MDD/GMP/GLP and SHE requirements.
- Represent the technical operations function on drug product cross-functional development teams, ensuring the provision of appropriate data (technical, resource & budgetary).
- Develop and maintain a level of knowledge and competence, including specialist expertise in drug product manufacturing technologies, primary components and their manufacturability and visual inspections technologies.
- Ensure effective transition and manufacturing scale up of drug products and combination products and medical devices to operations.
- Work collaboratively with peers across several functions to build technical communities and collaboration.
- Be recognized internally and externally as an expert in their specialist area
- Be recognized and in demand as a problem solver for key technical challenges in their area of expertise
- Demonstrate creativity and innovation to implement new methods, products, technologies or ways of working in area of expertise
- Greater than 7 years’ experience in drug product/ parenteral and/or biotech/pharmaceutical company
- Extensive technical knowledge of commercial drug product technology (greater than 5 years direct experience with drug product development, manufacturing or commercialization)
- Experience supporting commercial biological drug products and devices is a plus
- Broad based understanding of drug development process from late stage development through commercial life-cycle management.
- Experience working with cGMP and supporting regulatory inspections is a plus
- Excellent communications skills with the ability to work effectively in cross functional teams and effectively influence team members. Establish effective relationships with stakeholders.
- Ability to work in a complex, dynamic, global environment and willingness to travel when necessary.
- Innovative problem-solving skills
- Strong technical writer
- Statistical analysis experience
- MS in chemical or biomedical engineering or related engineering/ scientific field
- Advantageous to have experience of preparing regulatory documentation (ideally in CTD format)
- Demonstrated experience developing and/or sustaining drug product and/or devices (Medical Devices and/or Combination products) within a pharmaceutical environment. Experience with biologics a plus.
- A thorough understanding of the principles and concepts in relation to drug product development and lifecycle management. The role holder will be required to keep up to date with developments within the industry and understand how they may impact the function, e.g. regulatory guidelines
- Experience in development of risk based control strategies for medical device and combination product manufacturing
- The role requires project management and innovation skills, and a thorough understanding of design work and regulatory requirements, such as risk management, design controls, purchasing controls and design change.
- An in-depth knowledge of relevant compliance systems as appropriate to own function.
- Good knowledge of medical device and risk management regulatory requirements (e.g. ISO 13485, ISO 14971, CFR 820)
- Have a basic understanding of the overall drug or biologic development process from discovery through to launch.
- Have experience of technical supervision, coaching and mentoring or leading small matrixed teams of people or scientific projects.
- Evidence of strong communication skills and of building good relationships with cross functional team members and customers.
- Proficient experience in Microsoft Windows applications, CAD systems, Risk- and Change Management Tools and methodologies