Manager, Analytical Development - Small Molecules
Atrium, Boston, MA, United States
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 the 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.
Key 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 scientifically sound solutions to root cause identification of quality events
Reviewing the 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
Minimum Qualifications
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
Preferred Qualifications
Background and knowledge of process chemistry, in support of process development and process validation
Experience supporting development activities and troubleshooting manufacturing issues using various analytical techniques
Knowledge of DoE and QbD tools for process development and characterization
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small-molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain.
12 months.
Pay Range $55/hr - $65/hr
Shift/Hours Monday - Friday
#J-18808-Ljbffr
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.
Key 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 scientifically sound solutions to root cause identification of quality events
Reviewing the 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
Minimum Qualifications
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
Preferred Qualifications
Background and knowledge of process chemistry, in support of process development and process validation
Experience supporting development activities and troubleshooting manufacturing issues using various analytical techniques
Knowledge of DoE and QbD tools for process development and characterization
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small-molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain.
12 months.
Pay Range $55/hr - $65/hr
Shift/Hours Monday - Friday
#J-18808-Ljbffr