- Coordinates all aspects of managing / method development and validation and specialty service areas within the division.
- Supervises and assists senior technical staff in laboratory operations such as scheduling, resource management, technical and compliance related issues.
Autologous gene therapies – expertise in navigating the CMC aspects of this work through an operations role
Experience in Gene Therapy potency Assays. Transduction / Transfection.
- Interfaces with clients on scientific issues, study design and project technical requirements.
- Plans, directs and implements improvements in systems, processes and procedures to increase efficiency, productivity, quality and technical expertise in the laboratory.
- Assists division director in strategic planning, business development and new technology implementation.
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12 years’) or equivalent combination of education, training, and experience.
- OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 10 year)
- OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 8 year)
- Excellent technical capabilities with analytical expertise in method development and/or specialty technology
- Effective written and oral communication skills as well as presentation skills
- Demonstrated coaching and mentoring skills
- Proven problem solving and troubleshooting abilities
- Ability to drive implementation of new systems or enhance existing ones
- Proven ability to implement change based on analysis of root causes, need, and experience and drive cross-function SOP changes
- Strong organizational agility and demonstrated drive for results
- Knowledge of budgeting, forecasting and fiscal management
- Proven ability to identify and implement common efficiencies across multiple programs/projects
- Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
- Occasional drives to site locations, occasional domestic travel.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions.
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
- Occasional mobility needed. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
- Requires multiple periods of intense concentration.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
- Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.