PPD is a leading global contractresearch organization. At PPD we are passionate, deliberate, and drivenby 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.
As a Scientist,you will use state-of-the-art technologies to perform high-quality sampletesting for key pharmaceutical clients across the industry. Your samplepreparation and sample analysis serves as an integral piece in helping PPDaccomplish our goal of helping bring life-changing therapies to market.
Responsibilities for this position:
We are looking for a highly motivated person who supports analytical development and routine testing of NBEs. The candidate will identify, investigate and implement novel experimental approaches to answer scientific questions to develop and optimize NBE drug product formulations. Working closely with formulation and process development scientists, the candidate will develop productive collaborations and communications with scientific teams.
Section I: Major Responsibilities
- Analytical characterization and assessment of clinical trial supplies (e.g. GMP compliant stability and release testing)
- Execute and design experiments for method validation studies.
- Documents experimental data appropriately in laboratory documentation system and technical memos; contributes to writing technical reports.
- Maintains laboratory equipment and optimize laboratory operations for efficient use of time and resources.
- Lead troubleshooting of equipment and experimental problems.
- Brainstorm ideas for continuous improvement activities and leads initiative.
- Responsible for compliance with all applicable Client policies and procedures.
- Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
- Works with analytical methodology, such as chromatography, KF, UV and compendial methods. Also works with bioanalytical techniques such as WCX, HIC, SEC, CGE, icIEF, particle imaging, ELISA and/or LC-MS
Works with multiple functional groups to meet business needs
Plans and organizes work with periodic supervision
Sets up and maintains analytical instrumentation
Ensures QA findings are addressed appropriately
Communicates project status to project leaders
Provides assistance and training to other team members
Performs work assignments accurately, and in a timely and safe manner
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)
At PPD we hire the best, develop ourselves andeach other, and recognize the power of being one team. It's not just talk, ouraward-winning training programs speak for themselves.
To learn how PPD can advance your career, apply now!
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition department will review your qualifications and if interested, you will be contacted for an interview.
Education and Experience:
- 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 2+ years’) or equivalent combination of education, training, & experience. OR Masters degree
Knowledge, Skills and Abilities:
- Experience in analytical methodology, such as chromatography, KF, UV and compendial methods. Experience in bioanalytical techniques preferred (WCX, HIC, SEC, CGE, icIEF, particle imaging, ELISA and LC-MS)
- Manual dexterity.
- Communicate effectively and follow detailed written and verbal instruction.
- Cooperate with coworkers within an organized team environment or work alone with supervision.
- Experienced in laboratory systems (LIMS, CDS, ELN) preferred.
- Experience in Microsoft Office (Excel, Power Point, and Word) required.
- Statistical knowledge and experience is preferred e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies
- Manage time effectively to complete assignments in expected time frame.
- Maintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOP.
- Proficient in the use of analytical instrumentation, skills in separation science techniques (HPLC, GC and CE) are desired.
Proficient in sample extraction procedures.
- Ability to plan, schedule and carry out work for successful project completion.
- Proficient in the operation of the computer and data acquisition programs.
- Positive attitude and ability to work well with others.
- Ability to write protocols and reports with minimum supervision
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 typically found in healthcare or laboratory environments
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities