Manager, Analytical Development Small Molecules (Contract)

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.

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 scientific-sound solutions to root cause identification of quality events
• 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

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 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

Preferred Qualifications:

• 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

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Companys strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertexs product pipeline is focused on viral diseases cystic fibrosis inflammation autoimmune diseases cancer and pain.

Contract Length: 12 months.

$55/hr. - $65/hr.

Monday - Friday

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; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party 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 job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

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