Analytical Chemistry Senior Manager (Contract)

Job Description

Analytical Chemistry Senior Manager

Vertex is seeking a talented, experienced analytical chemist to support existing commercial products and 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.

 

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 and drug substances, leading analytical OOS/OOT investigations and assisting process investigations
• 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

 

Knowledge and Skills:

• 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
• Problem-solving/root cause analysis for analytical related issues
• Experience with chromatography methods such as HPLC, GC, 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
• Strong practical analytical chemistry skills across a range of general analytical techniques that must include (U)HPLC and GC
• Advanced organic chemistry skills to ensure appropriate analytical measurements and suggestions / discussion with partner functions
• Demonstrated analytical leadership including the ability to work successfully in both a team/matrix environment as well as independently
• The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects
• Advanced written and verbal communication skills
• Has knowledge of relevant science beyond analytical chemistry relevant to pharmaceutical development
• Displays ability to productively disseminate ideas across discipline- and project-boundaries
• Communicates effectively in verbal presentations and in writing technical reports
• Demonstrates ability to solve complex problems to attain crucial project goals
• Experience in multiple analytical techniques such as liquid chromatography, dissolution, Karl Fischer, mass spectrometry, NMR, or other analytical techniques relevant to drug development
• Familiar with cGMPs (e. g. Quality Control) concepts
• Demonstrated experience as a team player and collaborator with excellent organizational and project management skills
• Able to teach others scientific theory/application

 

Education and Experience:

• Bachelor's, Master's, or PhD in Analytical Chemistry, Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences or other natural science
• Typically requires the following, or the equivalent combination of education and experience: PhD and 2+ years, or Master's and 5+ years, or Bachelor's and 8+ years.

 

Pay Range

$70-$80/HR

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compen