Associate Group Leader / Group Leader - Biopharm - HPLC , ELISA , cIEF and cGMP - 145519
EXPECT MORE FROM YOUR CAREER
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - toimprove health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-timebenefits/advantages of being a part of PPD.
- Provides line-level management coordination of resources and work schedules for laboratory activities.
- Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs.
- Ensures that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed.
- Ensures that laboratory staff continues to be developed to keep pace with department goals and growth.
Education and Experience:
- Bachelor of Science Degree in Biology, Chemistry or related field
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6 years) or equivalent and relevant combination of education, training, & experience.
- 1+ year of leadership responsibility
Knowledge, Skills and Abilities:
- Demonstrated proficiency on technical operating systems
- At least one year of cGMP in an pharma industry lab is required.
- Demonstrated experience with HPLC, ELISA, and/or cIEF
- Proven leadership skills
- Ability to train and mentor junior staff
- Demonstrated ability to be project solution driven
- Good written and oral communication skills as well as presentation skills
- Can independently perform root cause analysis for method investigations
- Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.)
- Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs
- Ability to independently optimize analytical methods
- Project and time management skills
- Work is performed in an office and/or a laboratory and/or a clinical environment with exposure to electrical equipment.
- Occasionally drives to site or client locations, occasionally travels within the United States.
- 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.
- Frequently stationary 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.
- Occasional mobility required.
- Occasional crouching, stooping, 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 moderately complex information and ideas so others will understand; with the ability to listen toand understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others, relates sensitive information to diverse groups.
- Ability to apply basic principles to solve conceptual issues.
- 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.