Bethesda Metro Area, MD
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.
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