Associate Director, Analytical Development

Company: Green Key Resources
Location: Boston
Posted on: January 15, 2021

Job Description:

Analytical Development /Associate Director at Bioscience Company in Boston, Massachusetts, United States -

• Bioscience Company
• 12/6/20 Job ID: 1361366 Job Description Responsibilities:
  • Leads science-driven, phase appropriate, and risk-based analytical development and specification setting to support clinical programs from phase-1 to commercial registration.
  • Drives method development, release testing, stability studies, and method validations to enable clinical advancement at contract sites.
  • Critically reviews data from contract partners, provides timely feedback to secure prompt resolution of technical and quality findings.
  • Works collaboratively with cross-functional partners to proactively communicate analytical outcomes that may impact other areas and solicit input to drive analytical activities to timely and quality finish in support of overall project timelines.
  • Work closely with contract partners to build relationships and obtain necessary support and resources to complete projects.
  • Authors and reviews relevant sections of CMC documentation in support of INDs, IMPDs and NDA submissions and amendments, information package in support of meetings with regulatory authorities.
  • Serves as a subject matter expert on multiple projects, authors and reviews technical reports, memos, change control documents, deviation and investigation reports to capture development efforts, rationales and justifications of approaches and positions.
  • Follows process to drive change control, perform impact assessment and lead material review board technical discussions.
  • Manages stability programs for the assigned projects. Proactively reviews and trends data using statistical data packages to justify API retest period or DP shelf-life.
  • Serves as a member of the CMC team, assess capabilities and processes, and take initiative in promoting best practices for continuous improvement for CMC team. Qualifications Required Qualifications:
    • Minimally a MS degree in analytical chemistry with a minimum of 15 years method development (or PhD with 10 years' experience) experience in pharmaceutical industry is required.
    • In depth technical understanding of all aspects pertaining to analytical testing, in process controls, characterization of APIs and pharmaceutical products. Stays current with industry trends.
    • Has direct experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization, to support late stage product development and global commercial registration submissions.
    • Has prior experience in managing contract manufacturing organizations and contract laboratories including data review and oversight of product release and stability testing.
    • Is detail oriented, has excellent follow through, and is persistent in ensuring investigations are resolved in a timely manner.
    • Accomplishes results through individual contributions with significant independence in their assignments and flexibility in embracing changes.
    • Demonstrates advanced team facilitation skills that consistently foster effective brainstorming and decision making.
    • Provides budget input as needed for the team to make decisions.
    • Uses good judgement in effecting compromise to resolve conflicts. Develops and implements department processes that directly support and may have significant impact on team performance.
    • Excellent written and oral communication skills, with the ability to communicate complex information allowing for an open and effective dialogue throughout the company.
    • Strong organizational skills with the ability to effectively multi-task and prioritize
    • Ability to flexibly adapt to changing business needs and meet timelines
    • Ability to analyze & interpret stability data
    • Strong attention to detail and quality are critical to success
    • Resourceful, self-starter and team player with a strong results orientation
    • Able to command respect from peers and capable of highly independent work as well as being a team player and role model.
    • Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
    • Proven ability to manage multiple projects, identify and resolve issues.
    • Broad experience in a small company environment is a plus Enter keywords and/or location to get started. City or State Explore your Recruiting Career Discover the wide range of opportunities Green Key has to offer. You've worked hard for your industry experience. Now put that experience to work. Join the list to receive our monthly newsletter

Keywords: Green Key Resources, Boston , Associate Director, Analytical Development, Executive , Boston, Massachusetts