Sr. Formulations Development Scientist- Emulsion or Parenterals

** Please do not apply if you do not have a background that meets the
criteria listed in this job posting **FORMULATION DEVELOPMENT SCIENTIST JOB DESCRIPTION:
The Formulation Development Scientist must have a BS or PhD. Emulsion
and/or Liposoman formulation of parenterals experience is a big plus!May work within the Product and Process Development Department in support
of: Product Development for contract customers, Product Development,
National Cancer Institute Contracts, Manufacturing, Process Validation,
Quality Assurance/Control and Engineering technical requests. Independently
evaluates the chemical and physical properties of active pharmaceutical
ingredients and excipients to determine optimum procedures for
solubilization and stabilization in a parenteral formulation. Evaluates the
risk profile for the stability of formulation components by means of
degradation reactions caused by the chemical state of the formulation and
variable storage conditions. Evaluates the compatibility of the chemical
formulation and the container/closure components. Develops and tests
formulations from lab scale to full scale production size. Evaluation of
proposed formulation, processing procedure and selected container/closure
system through pilot batch testing and development stability studies.
Prepares and executes approved protocols to document the preparation,
testing and stability of proposed formulations and container/closure
systems. Prepares and executes study protocols for the purpose of providing
technical support as requested by other departments or external customers.
Participates in and contributes to the process of transferring product
manufacturing and testing procedures to the Production and Quality Control
departments. This responsibility includes the preparation of manufacturing
batch records and on site monitoring of production batches. Performs
miscellaneous duties as assigned by immediate supervisor or team leader in
support of team obligations.PRODUCT DEVELOPMENT SCIENTIST JOB DESCRIPTION:Work within the Product and Process Development Department in organizations
development effort for Customer/Toll Clients, Generics, Joint Ventures,
National Cancer Institute Contracts, internal development support for
Manufacturing, Process Validation, Quality Assurance/Control and
Engineering. Responsible for analytical test methods development,
qualification and validation. Formulation and lyophilization cycle
development and scale-up to production size. Evaluation of proposed
formulation, processing procedure and selected container/closure system
through pilot batch testing and development stability studies. Development
batch, In-process testing, Final Product, Raw Material and various
Stability tests.



job Requirements


REQUIREMENTS FOR FORMULATIONS DEVELOPEMENT SCIENTIST:Requires a four year degree in pharmaceutical chemistry (PhD is preferred
in overall science or chemistry background). Must have industry experience!
The position requires a proficiency in formulation chemistry and the
physical characterization of pharmaceutical chemicals using state of the
art procedures and equipment. One to two years of pharmaceutical product
development experience desirable. Experience should include the
demonstration of knowledge of pharmaceutical solubilization and formulation
concepts, problem-solving, experimental design, as well as computer
literacy and documentation/report writing. Experience in parenteral product
development including lyophilization is desired.REQUIREMENRS FOR THE PRODUCT DEVELOPMENT SCIENTIST:
Work with the Product and Process Development Department in organization's
development effort for Customer/Toll Clients, Generics, Joint Ventures,
National Cancer Institute Contracts, internal development support for
Manufacturing, Process Validation, Quality Assurance/Control and
Engineering. Responsible for analytical test methods development,
qualification and validation. Formulation and lyophilization cycle
development and scale-up to production size. Evaluation of proposed
formulation, processing procedure and selected container/closure system
through pilot batch testing and development stability studies. Development
batch, In-process testing, Final Product, Raw Material and various
Stability tests.
Qualifications/Experience for PRODUCT DEVELOPMENT SCIENTIST:
Requires a 4-year degree in Chemistry or closely related science.
Demonstrated proficiency with HPLC, GC, IR, UV, KF and TLC as well as wet
chemistry techniques. Minimum of two years of extensive pharmaceutical
product development experience. Experience must include demonstrated
knowledge of formulation concepts, analytical methods development,
research, problem-solving, and experimental design, as well as computer
literacy and documentation/report writing preferred. Experience in
parenteral product development including lyophilization is desired.