Associate Director, Analytical Development
Job description
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through our Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, heart failure, diabetes and metabolism and other indications.
We have offices in The Woodlands, Texas and Bridgewater, New Jersey. Lexicon employees are inspired by the idea that their work can improve patients' lives and we know that our employees are important to the success of our mission. We are dedicated to making Lexicon a great place to work by providing employees with the benefits, services, and programs which will allow them to reach their full potential.
Lexicon Pharmaceuticals is currently recruiting for a agile, results focused Associate Director, Analytical Development to join our team. This role can be based out of our Bridgewater, New Jersey or The Woodlands, TX locations.
Job Summary:
The incumbent will have the following responsibilities:
- Participate in cross-functional teams as the analytical SME
- Manage analytical method development, validation and transfer at Lexicon’s contract manufacturing organizations
- Collaborate with development teams to ensure methods are robust and appropriate for a QC commercial laboratory
- Review quality control documentation, including method validations/transfer protocols/reports, batch releases, stability studies protocols/reports, reference standards qualification protocols/CoAs and associated raw data records in support of drug substance and drug product manufacturing at contract manufacturing organizations
- Review laboratory investigation reports and CAPAs
- Review of change controls for impact to analytical methods and method validation status based on changes to manufacturing process or materials, compendial monographs/ chapters., specification changes and other reasons
- Provides expertise and guidance to problem-solving efforts at the third-party manufacturing and testing sites, including laboratory investigations and troubleshooting QC and operational issues.
- Resolving quality related issues relevant to analytical development and QC
- Author/update/review analytical parts of the drug substance section of regulatory submissions
- Promotes a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication
Education and Experience:
- BS in in analytical chemistry or related field with at least 12 years; or MS in science with at least 10 years; or Ph.D. with at least 8 years of relevant pharmaceutical experience
- Thorough knowledge of cGMP/GLPs in the pharmaceutical industry, as well as technical expertise as it relates to filing and pharmacopeias requirements
- Understanding of the regulatory requirements in CMC development
- Solid understanding of organic chemistry highly desirable
- Demonstrated ability to be SME for analytical trouble-shooting and problem-solving
- Experience in the authoring and reviewing technical documents
- Demonstrated ability to drive performance and achieve results
- Detail oriented and good organizational skills
- Excellent oral and written communication skills
- Ability and willingness to work in a team environment
- Embraces the ideas of others, nurtures innovation and manages innovation to reality
For additional information about Lexicon and its programs, please visit www.lexpharma.com .
Lexicon requires all field-based new hires to be fully vaccinated with a COVID-19 vaccine as
Lexicon Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test, background check and verification of credentials before beginning employment.
Lexicon Pharmaceuticals is an equal opportunity/affirmative action employer - Females, Minorities, Veterans, and Disabled.
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