Analytical Development /Associate Director at Bioscience Company in Boston, Massachusetts, United States —
- bio Pharmaceutical
- Bioscience Company
- Boston, Massachusetts, United States USA
- 1/19/21 2021-01-19
Job ID: 1361366
- 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.
- 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
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