Sage Therapeutics

  • Associate/Director, Oral Drug Product Technology

    Job Locations US-MA-Cambridge
    Posted Date 2 weeks ago(5/14/2018 1:54 PM)
    ID
    2017-1527
    # of Openings
    1
    Category
    Tech Ops
  • Overview

    General Scope and Summary

     

    The successful candidate will participate in drug product process development and manufacturing activities for difficult to solubilize products. He/she will help develop late stage and commercial oral formulations, with an initial emphasis on capsule and tablet formulations, and manufacturing strategies and plans, including critical process parameter assessments, process characterization and improvements, and validation activities, and post launch manufacturing support. He/she will be responsible for integration of these activities in alignment with evolving cross-functional development plans, and execution of process optimization and manufacturing at external partners.

     

    Roles and Responsibilities

     

    • Helps develop late stage/commercial capsule and tablet formulations and manufacturing plans for difficult to formulate products in close collaboration with the Head of Pharmaceutical Development, Director of Formulation Development, Project and CMC teams and related functions, including Analytical Development, Quality and Regulatory
    • Actively participates in CMC teams and oversees drug product process development and manufacturing activities at external manufacturing facilities
    • Authors formulation and manufacturing related sections for regulatory filings, development reports and other development related documents
    • Is responsible for establishing a drug product manufacturing infrastructure with systems that are consistent with accepted pharmaceutical quality standards in conjunction with other related functions
    • Actively communicates, collaborates with and contributes to other functional areas and drives to achieve the best development and business results for SAGE

     

    Experience, Education and Specialized Knowledge and Skills

     

    The successful candidate has a broad understanding of solid oral formulation development, drug product process development, scale-up, and validation of manufacturing processes. The candidate should have a proven track record in developing capsule formulations for oral administration for difficult to solubilize products through early clinical development and process validation. Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment, as well as a proven ability to achieve results in an outsourced model utilizing external manufacturing facilities are a must. Experience with other formulations, including sterile manufacturing, are a plus. Other requirements are:

     

    • Degree in Engineering, Materials Science, Pharmaceutics, Chemistry or a related field, Ph.D. preferred
    • 10+ years relevant small molecule solid dosage form process development and manufacturing experience in the pharmaceutical industry
    • Experience in development, characterization, and improvement of manufacturing processes for new products for multiple delivery systems with a major emphasis on capsules and tablets
    • Experience in solids/powder processing and development of solid dosage formulations with an emphasis on capsules and tablets
    • Extensive knowledge and expertise in the development and validation of capsule and tablet manufacturing processes
    • Extensive knowledge and expertise in blending and material mixing technologies as related to blend and content uniformity
    • Experience in granulations technologies such as fluid-bed, high-shear, roller compaction, pelletization, and extrusion (ideally continuous and batch process)
    • Develop and implement design protocols for development, IQ/OQ, and validation activities
    • Experience with sizing and classification of materials using such equipment as: fitzmills, oscillators, pulverizers, Cone Mills, tornado mills, jet mills, Netzsch mills, granumills, etc
    • The ability to integrate and extrapolate data from various analytical techniques, such as particle size analysis, hardness, friability, dissolution, optical measurements, moisture analysis (LOD), density determinations, GC, HPLC, ICP FTIR, UV/VIS and microbiological parameters
    • Experience with GMP manufacturing oversight, including batch record and change management
    • Strategic vision, as well as hands on problem solving skills
    • Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies (up to 30% travel)
    • Experience with authoring and review of drug product sections in the CMC sections of regulatory submissions
    • Embraces our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
    • Excitement about the vision and mission of Sage

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