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.
The department for this position is a science-driven organization dedicated to building in-depth and comprehensive knowledge of our products and their processes through well-designed analytical studies. We work in all phases of pharmaceutical development to oversee the analytical processes for drug substance development both internally and with external contract service providers. Our goal is to enable the establishment of specifications and robust analytical procedures that allow control of our drug substance processes to provide safe, efficacious and high-quality products to the patients we serve.
Responsibilities I will include, but are not limited to, the following:
In this position you will be responsible for the development and qualification of analytical methodology for the characterization of our API, intermediates, and starting material, including IPC, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development. Support for an increasingly complex portfolio of small molecules and milla-molecular (ADCs, peptides, oligonucleotides) drug candidates across all stages of development and, as needed, within our commercial product portfolio will be required.
In this position you should be able to work with minimal supervision to carry out laboratory based de novo analytical methods development, chemical characterization studies and chemical stability characterization evaluations. Where required, activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures.
- Support drug substance process development including characterization of starting materials, intermediates and final API.
- Support in process control testing.
- Develop, optimize and qualify/validate analytical methods.
- Support drug substance impurity characterization and identification.
- Generate/review laboratory testing and stability data.
- Collaborate with project teams to help solve challenging problems encountered to support route selection and process optimization studies conducted by chemist and chemical engineers.
- Qualify/transfer analytical methodology to quality control and contract laboratories.
- Report and discuss analytical results and conclusions both orally and in writing.
- Review analytical data for completeness and correctness.
- Complies with Environmental Health and Safety Requirements.
- Contributes to ownership and advancement of lab instrumentation, work processes, and procedures.
PPD Defining Principles:
We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
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).
Knowledge, Skills and Abilities
- Strong Scientific problem solving skills
- Skills in operating instrumentation such as HPLC, GC, KF, etc that are common in laboratories and Empower HPLC operations
- Familiarity with synthetic chemistry, drug substance processing, pharmaceutical processing and/or pharmaceutical sciences.
- Experience in the development and performance of analytical tests for a variety of drug substances, intermediate, and starting materials. Experience in supporting API development preferred.
- At least one year of experience in a GMP regulated lab is required
- Strong verbal and written communication skills and interpersonal skills as a team member in an environment where individual initiative, collaboration and accountability are valued.
- A demonstrated record of scientific accomplishment and laboratory experimentation,
- Knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance.
- Familiarity with the USP and other compendia and how they impact drug development
- Strong problem-solving and troubleshooting skills.
- Strong capabilities in experimental design and execution.
- Ability to work independently.
- Understanding of cGMP/GLP and GDPs practices and EHS requirements is essential. Ability to comply with all applicable SOPs, internal ADT requirements and external regulations is a must.
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 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.