Analytical Chemistry Senior Manager (Contract)

Analytical Chemistry Senior Manager

Vertex is seeking a talented experienced analytical chemist to support existing commercial products and latestage 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 covalidation to support latephase 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 CMOs 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 smallmolecule drug substance IPC release and stability methods
• Experience in an analytical development or technical operations role supporting new product development and commercialization
• Problemsolving/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 cGMPs (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 projectboundaries
• 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:

• Bachelors Masters 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 Masters and 5 years or Bachelors and 8 years.

$70$80/HR

This job posting is for a temporary role with a thirdparty 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; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the thirdparty agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other jobrelated factors permitted by law. In addition this role will be eligible for overtime pay in accordance with federal and state requirements

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