Scientist - Drug Product Development

PPD is a leading global contract research organization. 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.

This position will be part of Sterile Product Development within Drug Product Development organization located in New Brunswick, NJ. The Scientist will support the studies on new drug candidates to define biophysical and chemical properties of biologics using a wide variety of analytical tools, as well as to develop parenteral dosage forms and their manufacturing processes to enable clinical and commercial use.

Responsibilities Support other scientists on day to day activities of analyzing samples, setting up stability studies, maintenance of lab equipment Conduct experiments on new drug candidates and formulations to define biophysical and chemical properties of biologics using various analytical characterization tools Develop parenteral dosage forms for clinical and commercial use throughout various stages of development. Generate data and knowledge for regulatory filings through planning and execution of experimental plans with minimal supervision, within project timelines. Help scientist to conduct process development, optimization and scale-up studies; bring this knowledge to project teams to enable successful drug product technology transfer to clinical manufacturing and commercial sites. Ensure compliance to safety rules and regulations, experimental best practices, electronic laboratory notebook, other expectations and trainings based on corporate and regulatory guidelines. Comprehensive knowledge and understanding of protein folding and structure-activity relationship, protein/peptide chemistry, chemical and physical stability. Hands on experience with various biophysical and biochemical analytical tools used for characterization and development including but not limited to SEC-HPLC, UV-absorbance, DLS etc. Knowledge of fundamental principles of pharmaceutical science essential for the development of injectable dosage forms of small molecule, protein and peptide therapeutics. Basic understanding of process development (lyophilized or ready-to-use) and scale-up of injectable dosage forms to clinical or commercial manufacturing sites is preferred. Excellent team player with good interpersonal, written, verbal communication skills.

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. 

*LI-SW1

PPD is a leading global contract research organization. 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.

This position will be part of Sterile Product Development within Drug Product Development organization located in New Brunswick, NJ. The Scientist will support the studies on new drug candidates to define biophysical and chemical properties of biologics using a wide variety of analytical tools, as well as to develop parenteral dosage forms and their manufacturing processes to enable clinical and commercial use.

Responsibilities Support other scientists on day to day activities of analyzing samples, setting up stability studies, maintenance of lab equipment Conduct experiments on new drug candidates and formulations to define biophysical and chemical properties of biologics using various analytical characterization tools Develop parenteral dosage forms for clinical and commercial use throughout various stages of development. Generate data and knowledge for regulatory filings through planning and execution of experimental plans with minimal supervision, within project timelines. Help scientist to conduct process development, optimization and scale-up studies; bring this knowledge to project teams to enable successful drug product technology transfer to clinical manufacturing and commercial sites. Ensure compliance to safety rules and regulations, experimental best practices, electronic laboratory notebook, other expectations and trainings based on corporate and regulatory guidelines. Comprehensive knowledge and understanding of protein folding and structure-activity relationship, protein/peptide chemistry, chemical and physical stability. Hands on experience with various biophysical and biochemical analytical tools used for characterization and development including but not limited to SEC-HPLC, UV-absorbance, DLS etc. Knowledge of fundamental principles of pharmaceutical science essential for the development of injectable dosage forms of small molecule, protein and peptide therapeutics. Basic understanding of process development (lyophilized or ready-to-use) and scale-up of injectable dosage forms to clinical or commercial manufacturing sites is preferred. Excellent team player with good interpersonal, written, verbal communication skills.

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. 

*LI-SW1

Education and Experience:   Bachelor's degree in Chemistry, Biology, Biochemistry, Chemical engineering or equivalentand relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years). Or Master's degree in Chemistry, Biology, Biochemistry, Chemical engineering with 0 to 2 years experience 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:

Hands on experience with various biophysical and biochemical analytical tools used for characterization and development including but not limited to SEC-HPLC, UV-absorbance, DLS etc.

Knowledge of fundamental principles of pharmaceutical science essential for the development of injectable dosage forms of small molecule, protein and peptide therapeutics.

Basic understanding of process development (lyophilized or ready-to-use) and scale-up of injectable dosage forms to clinical or commercial manufacturing sites is preferred.

Excellent team player with good interpersonal, written, verbal communication skills.

Solid understanding and knowledge of general chemistry and separation science

Technically competent in basic formulation/process development techniques

Demonstrates competence and experience in proper handling, recording and analysing scientific experimental data

Has operational knowledge of routine laboratory/plant equipment

Understands the basic principles, concepts and methodology governing the work performed

Proficient in Microsoft Excel and Word

Proven ability in technical writing skills

Ability to independently optimize analytical methods

Proven problem solving and troubleshooting abilities

Good written and oral communication skills

Time management and project management skills Ability to work in a collaborative work environment with a team

Working Environment:  

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.    

Education and Experience:   Bachelor's degree in Chemistry, Biology, Biochemistry, Chemical engineering or equivalentand relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years). Or Master's degree in Chemistry, Biology, Biochemistry, Chemical engineering with 0 to 2 years experience 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:

Hands on experience with various biophysical and biochemical analytical tools used for characterization and development including but not limited to SEC-HPLC, UV-absorbance, DLS etc.

Knowledge of fundamental principles of pharmaceutical science essential for the development of injectable dosage forms of small molecule, protein and peptide therapeutics.

Basic understanding of process development (lyophilized or ready-to-use) and scale-up of injectable dosage forms to clinical or commercial manufacturing sites is preferred.

Excellent team player with good interpersonal, written, verbal communication skills.

Solid understanding and knowledge of general chemistry and separation science

Technically competent in basic formulation/process development techniques

Demonstrates competence and experience in proper handling, recording and analysing scientific experimental data

Has operational knowledge of routine laboratory/plant equipment

Understands the basic principles, concepts and methodology governing the work performed

Proficient in Microsoft Excel and Word

Proven ability in technical writing skills

Ability to independently optimize analytical methods

Proven problem solving and troubleshooting abilities

Good written and oral communication skills

Time management and project management skills Ability to work in a collaborative work environment with a team

Working Environment:  

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.