Manager, Analytical Development - Small Molecules (Contract)

Atrium Works • Boston, MA

4d

About The Position

Vertex is seeking a talented, experienced analytical chemist for late-stage product development in a commercial setting. Working directly with our contract manufacturing organizations and a highly diverse group of scientists at Vertex you will solve complex problems encountered in commercial production/manufacturing of drug substances. You will be part of an organization that thrives on innovation and is at the forefront of implementing Quality by Design and Continuous Manufacturing. To be considered for this position the applicant will need to be a collaborative, experienced and competent analytical chemist with a history of developing, implementing and troubleshooting analytical methods in the pharmaceutical industry, with the ability to influence colleagues, and possessing strong communication and negotiation skills.

Requirements

• BS with 5+ years or MS. with 3+ years of relevant pharmaceutical experience
• Experience with small-molecule drug substance IPC, release and stability methods
• Experience in an analytical development or technical operations role, supporting new product development and commercialization.
• Experience with chromatography methods such as HPLC, GC, MS, and other common analytical techniques used in pharmaceutical analysis
• Experience with compendial methods for analysis (e.g. KF, elemental impurity testing, and identification by spectroscopy)
• Knowledge of cGMP’s (e.g. Quality Control), ICH guidelines and associated CMC regulatory considerations in a pharmaceutical setting
• Strong communication and technical writing skills
• Must be a committed team player and collaborator

Nice To Haves

• Background and knowledge of process chemistry, in support of process development and process validation
• Experience supporting development activities and trouble-shooting manufacturing issues using various analytical techniques
• Knowledge of DoE and QbD tools for process development and characterization

Responsibilities

• Method transfers for small molecule drug substance to various CMOs or between internal groups
• Method validation or co-validation to support late-phase and commercial projects
• Authoring/reviewing documentation to support new and existing commercial products (methods, SOPs, transfer protocols/reports, lab notebooks, technical reports, etc.)
• Independently managing CMOs for manufacturing of GMP starting materials, intermediates and drug substances, leading analytical OOS/OOT investigations/assisting process investigations and providing scientific-sound solutions to root cause identification of quality events
• Reviewing CMO’s analytical raw data and result reports including both release and stability data
• Commercial data collection, interpretation, reviewing, trending, and report generation to support continuous process verification
• Continuous method improvement through commercial change control procedures

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level