***This position requires long term eligibility to work in the US without sponsorship. Please note F-1 OPT Visas are not considered long term eligibility for this role.***
In labs and health care facilities worldwide – HERE WE ARE
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve 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-time benefits/advantages of being a part of PPD.
In this position you will be responsible for supporting a biological commercial lifecycle management team.
Responsible for supporting a biological commercial lifecycle management team. Supports subject matter experts on a multitude of projects that may include: attending meetings as a team representative, leading projects, technical writing, design and execution of lab experiments, training others, following SOPs, performing instrument or reagent substitutions, data interpretation and write up, documentation in accordance with procedures, data review and verification, protocol and report drafting, and general lab maintenance.
Responsible for working with cross functional teams on an instrument replacement project for a Biomek Liquid Handler and Vi-Cell Cell Counter. This involves researching suitable replacements, understanding method performance with use of the equipment, critical functionalities needed for compatibility, 21CFR11 compliance, comparability studies, experiment design and execution, and implementation planning in the QC labs.
- Independently performs analytical testing, method optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods, and protocols applicable to assigned tasks. Designs and executes experiments independently.
- Reviews and critiques study protocols, project status reports, final study reports and other projectrelated technical documents.
- Prepares and reviews study protocols, project status reports, final study reports and other projectrelated technical documents.
- Communicates data and technical issues to clients on a weekly basis (or as needed).
- Provides technical guidance and training to staff.
- Leads analytical (procedural and instrumental) troubleshooting sessions.
- Assists in preparation and implementation of SOPs and quality systems.
- Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Education and Experience:
- Bachelor’s degree or equivalent and relevant formal academic / vocational qualification with previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years in the pharmaceutical industry).
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Knowledge of bioassay, immunoassay, and bioanalytical science
- Experience with binding/potency ELISAs, impurity ELISAs, bioassays is preferred as well as experience with cell counters, automated liquid handlers, and multi-channel pipettes including experience with the software which may require script programming.
- Experience with SoftMax PRO software and Parallel Line Analysis (PLA) from Stegmann Systems preferred.
- Ability to independently work and progress through assigned projects while meeting timelines
- Proficiency on automated liquid handlers and cell counter systems
- Proven problem solving and troubleshooting abilities
- Proven ability in technical writing skills
- Time management and project management skills
- Good written and oral communication skills
- Ability to work in a collaborative work environment with a team
- Ability to train junior staff where necessary to complete experiments related to assigned projects
- Experience working in GLP or GMP regulated lab is strongly prefered.
PPD values the health and well-being 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 nontraditional 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
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.