Research Scientist - Formulation Development
0

applicants

1610

No. Views

 
 
Job Description:  Research Scientist in Formulation Development
 
Successful candidate will be involved in:
 
-          Development of conventional and alternative small and large molecule (protein/peptide) formulations and drug delivery/device products through the use of Design of Experiments (DOE).
-          Working with clients in establishing goals and timelines for projects
-          Performing in vitro models to critically assess formulation & delivery effectiveness/stability.
-          Manufacturing of toxicology supplies either directly (in-house) or indirectly (CMO)
 
Requirements - Qualifications:
 
The ideal candidate will have a degree in Pharmaceutics, Biochemistry, Chemical Engineering or related scientific discipline of small and/or large molecule formulation and drug delivery experience in oral, injectable and/or inhalation dosage forms.
 
 
Experience with lyophilization and/or spray-drying a plus.
 
Experience in multiple analytical, bioanalytical and biophysical assessment techniques for product characterization and product stability evaluation such as HPLC, GC, SDS-PAGE, SEC, Spectroscopy (UV/Vis, fluorescence, light scattering) ELISA, etc. is strongly preferred.
 


 
Basic Purpose and Objective:
Primary responsibilities involve the oversight of complex formulation and product development projects to create new small and large molecule drug products, investigate existing products or support internal product development efforts with clients.  Directs laboratory activities of technical staff.
 
Position Scope:
Generally supervises 3-4 direct reports.  This position is a 75% billable position.
 
Education and Experience:
  • PhD in chemistry, biology or appropriate related field with 2 years experience quantitative Bioanalysis work to include; validation, method development, and production using relevant immunochemistry or chromatography based technologies OR
  • MS in chemistry, biology or appropriate related field, with 5 years experience quantitative Bioanalysis work to include; validation, method development, and production using relevant immunochemistry or chromatography based technologies OR
  • BS in chemistry, biology or appropriate related field, with 7 years experience quantitative Bioanalysis work to include; validation, method development, and production using relevant immunochemistry or chromatography based technologies
Knowledge and Skills:
Creative, innovative self-starter, with excellent verbal and written communication skills, and the ability to work effectively as an individual contributor in team environment.
 
Full hands-on understanding of drug product formulation and drug delivery product development in oral, injectable and/or inhalation dosage forms.
 
Full understanding of cGMP requirements, SOPs, ICH guidelines, USP requirements and FDA guidances.
 
Proven formulation and product development abilities.
 
Effective technical writing skills
 
Ability to manage multiple projects and programs in the pharmaceutical/ biopharmaceutical industry or contract laboratory environment.
 
Ability to implement quality systems and process improvements.
 
Supervisory skills in resource allocation, hiring and recruiting and other related functions.
 
Hiring Preferences:
Expertise in lyophilization and/or spray-drying.
PPD is an Equal Opportunity Employer 
 
Additional Information
Location | Wisconsin | | Middleton Start Date 2013-07-09
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 09-Jul-2013


Contact Information
Company Name Pharmaceutical Product Development Telephone No Not Provided
Contact Name Site Link Not Provided
 

       

Latest Jobs

Senior Quality Specialist
Responsible for providing support to Operations staff in the implementation of and adherence to processes, controlled documents, tools and templates to enhance quality of deliverables. Activities may include: Identification of process gaps and/or improvement opportunities; process authoring and
Location Durham
Posted on 18-Jul-2013
Director, Product Management Platform
The Director, Platform Solutions will help drive the platform technology strategy, in partnership with Engineering, to help achieve the vision of providing a fully integrated eClinical suite to the biopharmaceutical market. This also includes the advancement of platform technologies, products,
Location Home Based
Posted on 18-Jul-2013
Senior Statistical Programmer
The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis
Location Hyderabad
Posted on 18-Jul-2013
Medical Information & Technology Specialist(based in Prague or Berlin)
The role can be based in Berlin or Prague • Provide technical 'Super User' support for the system used by Medical Services Assist with the identification and co-ordination of standardised methodologies relating to the safety database and other Medical Service systems • Act as a liaison point
Location Berlin
Posted on 18-Jul-2013
Senior Biostatistician
• Provide broad statistical support, including trial design, protocol and CRF development on specific studies • Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
Location Berlin
Posted on 18-Jul-2013
 

 
Home | My Account | Browse by company | Browse by category | Contact us | Terms | Privacy | FAQ