Senior Scientist

Business: Pharma Solutions
Department: Formulation R&D (FRD)
Location: Lexington, KY
 

Job Overview

The Senior Formulation Scientist is responsible for formulation development of sterile injectable dosage forms, from pre-clinical development through product commercialization. 

Key Responsibilities

•    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
•    Conduct administrative functions as required or assigned

Reporting Structure Directly reports to Manager, Formulation R&D
  Education Requirements •    BS in Chemistry, Biochemistry or Pharmaceutical Science or related discipline; advanced degree preferred   Experience

•    10+ years’ working within pharmaceutical industry, focusing on developing parenteral, solid and/or other formulation applications within a Clinical/Commercial manufacturing organization
•    Experience on a wide variety of dosage forms (i.e. parenterals, lyophiles, polymers, suspensions, drug delivery systems, etc.) design of experiments, statistics, and unique technologies 
•    Experience in lyophilization cycle development and suspension development 

Competencies

•    Thorough knowledge of relevant analytical techniques required for formulation and product analysis
•    Demonstrated ability to provide technical procedure/direction and interact professionally and effectively with management, peers, team members, supervisors, and outside customers on an ongoing basis to ensure product development success.  
•    Experience serving on interdisciplinary and multidisciplinary teams 
•    Strong technical aptitude; excellent organizational, technical, and creative problem solving skills.
•    Flexible and adaptable to changing priorities; comfortable working in a matrix environment, while embracing change.
 

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placem