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Formulation Development Specialist
Ref No.: 18-14821
Location: Lexington, Massachusetts
Job Title: Development Specialist - Formulation
Location: 200 Shire Way, Lexington, MA 02421
Duration: 12 Months

Description:

Primary Role
  • The candidate will be responsible for the design/execution of experimental procedures required for the development of robust formulations for biologics drug substance and drug product throughout their product lifecycle.
  • The candidate will be responsible for preparing formulation/stability samples and subsequently analyzing those samples.
  • The candidate should possess excellent communication (both written and oral) and should be seen as a proactive contributor.
  • The position will work closely with members of the Formulation Development and Analytical Development groups.

Responsibilities
  • Responsible for the completion of pre-formulation and formulation experiments leading to the improvement of long-term stability of proprietary biologics drug substance and product
  • Responsible for the analysis of stability samples
  • Interpret data from experiments performed to assess stability of drug substance and product
  • Works directly with other scientists, analytical staff, and quality groups internally to assure completion of delegated tasks that provided results are on-time, documented, technically sound and robust.
  • Author/review development documents

Education & Experience Requirements
  • B.S and/or M.S in Pharmaceutical Science, Pharmacy, Biochemistry, Chemistry, or Chemical Engineering
  • 3+ years industry experience in pre-formulation assessments, drug delivery or biologics formulation development
  • Excellent interpersonal skills
  • Strong problem solving abilities with a strong work ethic and dedication to completion of assignments
  • Demonstrated written and oral communication skills

Key Skills and Competencies
  • Experienced with HPLC techniques such as reverse phase, SEC, IEC
  • Experienced with biologics analytical techniques such as SDS-PAGE gels,
  • Experienced with the preparation of biologics stability samples such as buffer exchange
  • Familiar with the development of freeze-dried formulations of biologics
  • Familiar with cGMPs and Quality Assurance Guidelines
  • Must be well-organized and self-motivated, and possess an independent work style.
  • Excellent oral and written communication skills including the ability to deliver good presentations and well written technical documents.

Other Job Components
Complexity and Problem Solving
  • Demonstrate sound scientific judgment in decision-making while keeping open communications to ensure that all work and deliverables are timely and of high quality
  • Internal and External Contacts
  • Works closely with Project leads