Senior Scientist - Formulation - Sterile Suspension

Pharmaceutical Product Development (PPD)

PA-Collegeville-FSP Collegeville PA


Submission for the position: Senior Scientist - Formulation - Sterile Suspension - (Job Number: 184859)

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!  

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. 

As a Senior Scientist supporting the Pharm Dev Steriles in our client'sPharmaceutical R&D, you will have the opportunity to utilise technical skills and expertise to develop drug product formulations and associated manufacturing processes as part of a matrix technical team. You will also have the opportunity to use creative thinking to drive drug development of a variety of sterile product dosage forms

Key Responsibilities:

• Supports pre- and post-development candidates by screening and developing robust drug product compositions for a variety of traditional and non-traditional dosage forms including but not limited to nanosuspensions, hydrogels, emulsions, controlled release implants, and lyophiles.

• Executes preformulation, formulation and process development activities based on established protocols and procedures.

• Assists in the manufacture of batches of product as required, e.g. for process development, stability studies or clinical trials

• Coordinates his/her activities within Pharmaceutical Development and with analytical and manufacturing representatives to meet project deliverables

• Works with the matrix technical team to align and execute preformulation, formulation and process development activities including authoring or contributing to manufacturing batch records

• Identify and begin to interpret any problems in the execution of experimental processes and/or in results and communicates them to his/her supervisor

• Proactively engage and seek assistance from other scientists to solve problems

• Maintains cleanliness in own work area and in communal work areas

• Anticipates/recognizes potential problems with equipment and/or supplies, and proposes/initiates action to solve or prevent problems

• Operates equipment for which he/she is trained independently with due regard for GMP and Safety

• Works to GMP/GLP as appropriate

• Demonstrates timely & reliable recording of laboratory data in Labware and other suitable systems in accordance with company policy and legal requirements.

• Performs data management tasks including recording results effectively and in compliance with departmental guidelines in a laboratory notebook or computer with minimal supervision (e.g. tabulating and graphing results)

• Consults with supervisor when difficulties arise that cannot be readily resolved

• Prepares oral or written summaries of results with interpretation for project work

• Writes specific technical sections of internal and external reports with supervision

• Attends regular safety training and is fully aware of safety requirements for his/her laboratory/working environment

• Follows safe Laboratory and Manufacturing Practices

• Maintains accurate and complete safety records consistent with company policy and legal requirements

• Recognizes potential safety problems and takes action to rectify them

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.  

*LI-SW1

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!  

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. 

As a Senior Scientist supporting the Pharm Dev Steriles in our client'sPharmaceutical R&D, you will have the opportunity to utilise technical skills and expertise to develop drug product formulations and associated manufacturing processes as part of a matrix technical team. You will also have the opportunity to use creative thinking to drive drug development of a variety of sterile product dosage forms

Key Responsibilities:

• Supports pre- and post-development candidates by screening and developing robust drug product compositions for a variety of traditional and non-traditional dosage forms including but not limited to nanosuspensions, hydrogels, emulsions, controlled release implants, and lyophiles.

• Executes preformulation, formulation and process development activities based on established protocols and procedures.

• Assists in the manufacture of batches of product as required, e.g. for process development, stability studies or clinical trials

• Coordinates his/her activities within Pharmaceutical Development and with analytical and manufacturing representatives to meet project deliverables

• Works with the matrix technical team to align and execute preformulation, formulation and process development activities including authoring or contributing to manufacturing batch records

• Identify and begin to interpret any problems in the execution of experimental processes and/or in results and communicates them to his/her supervisor

• Proactively engage and seek assistance from other scientists to solve problems

• Maintains cleanliness in own work area and in communal work areas

• Anticipates/recognizes potential problems with equipment and/or supplies, and proposes/initiates action to solve or prevent problems

• Operates equipment for which he/she is trained independently with due regard for GMP and Safety

• Works to GMP/GLP as appropriate

• Demonstrates timely & reliable recording of laboratory data in Labware and other suitable systems in accordance with company policy and legal requirements.

• Performs data management tasks including recording results effectively and in compliance with departmental guidelines in a laboratory notebook or computer with minimal supervision (e.g. tabulating and graphing results)

• Consults with supervisor when difficulties arise that cannot be readily resolved

• Prepares oral or written summaries of results with interpretation for project work

• Writes specific technical sections of internal and external reports with supervision

• Attends regular safety training and is fully aware of safety requirements for his/her laboratory/working environment

• Follows safe Laboratory and Manufacturing Practices

• Maintains accurate and complete safety records consistent with company policy and legal requirements

• Recognizes potential safety problems and takes action to rectify them

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.  

*LI-SW1

Education and Experience:  

Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or Organic Chemistryor equivalent and relevant formal academic / vocational qualification (Master's Degree is preferred)

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years).

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:  

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 Experience in development of aqueous suspensions; Practical experience in operating wet bead milling, microfluidization, homogenization equipment strongly preferred Experience working in a GMP environment particularly for sterile products strongly preferred Can performs literature searches independently and understands scientific literature directly related to his/her experiments Can learn and apply new experimental techniques Has knowledge about regulatory requirements for sterile products.

Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff

Working Environment:  

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, 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 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 in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or Organic Chemistryor equivalent and relevant formal academic / vocational qualification (Master's Degree is preferred)

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years).

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:  

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 Experience in development of aqueous suspensions; Practical experience in operating wet bead milling, microfluidization, homogenization equipment strongly preferred Experience working in a GMP environment particularly for sterile products strongly preferred Can performs literature searches independently and understands scientific literature directly related to his/her experiments Can learn and apply new experimental techniques Has knowledge about regulatory requirements for sterile products.

Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff

Working Environment:  

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, 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 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 Submission for the position: Senior Scientist - Formulation - Sterile Suspension - (Job Number: 184859)


2021-02-18 00:00:00


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