Formulation Scientist

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Lexington,KYposted on:
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* * Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

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Job Title Formulation Scientist

Job Description Business:
Pharma Solutions  Department:
Formulation R&D (FRD)

Location:

Lexington
** Job Overview
** Reporting to the Formulation R&D Manager, the Formulation Scientist is responsible for formulation development of sterile injectable dosage forms, from pre-clinical development through product commercialization.
** Reporting Structure
** This position reports to the Formulation R&D Manager.
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* Key Responsibilities:

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* • Design studies related to pre-formulation and formulation of parenteral products, including solubility, pH solution stability, lyophilization, suspension development, polymer development and others that may impact the stability and delivery of the product.

• Experimental design, data evaluation, generation of scientific reports, and coordination studies with other technical groups  
• Plays an important role in the scale-up and technology transfer process in collaboration with Manufacturing team  
• Investigates, troubleshoots and resolves issues associated with formulation studies and/or R&D pilot manufacturing  
• Responsible, in collaboration with management, to develop and track project timelines and assumes departmental responsibilities for projects when necessary.

• Consults and interacts with internal cross-functional teams and external clients and customers  
• Operate equipment and apply analytical methodology utilized in the formulation development of parenteral dosage forms (e.g. lyophilizers, compounding/filling equipment, mixing techniques, sterilization techniques, HPLC, KF, particulate matter, etc.)  
• Apply and provide feasibility assessment for a variety of scientific principles and concepts to potential clients, products and investigations.

• Conducts literature searches to support formulation development and/or pilot manufacturing documentation  
• Effectively communicates and defends own work, orally and in writing, at team meetings, in technical documents, and to external partners  
• Assist, consult, and trouble-shoot during process transfer scale-up and validation activities  
• Interpretation of results and scientific information including proficiency in statistical evaluation of data and design of experiments.

• Interact with cross functional departments including Business Development, Project Management, ARD, QC, Process Development, Quality, Operations and with external clients    
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* Qualifications:

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* • BS in Chemistry, Biochemistry or Pharmaceutical Science or related discipline
• 2+ years’ industry experience, focusing on developing parenteral, solid and/or other formulation applications  
• Desired

Experience:

working within a variety of dosage forms (i.e. parenterals, lyophiles, polymers, suspensions, drug delivery systems, etc.) design of experiments, statistics, and unique technologies   
• Desired

Experience:

lyophilization cycle development and suspension development  
• Desired

Experience:

work within a clinical/commercial manufacturing organization
• Knowledge of relevant analytical techniques required for formulation and product analysis   
• Ability to serve interdisciplinary and multidisciplinary teams is required.

• Strong…