Associate Director, Pharmaceutics
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science, based on Nobel Prize-winning technology, to discover and develop precise medicines for patients with serious, chronic conditions.
Our world class research and commercialization teams are located in Basking Ridge, New Jersey and The Woodlands, Texas. 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.
We are currently recruiting for an agile, results focused Associate Director, Pharmaceutics in The Woodlands, Texas.
This position is responsible for the development of appropriate pharmaceutical formulations for novel, first in class, compounds and will manage activities at external CROs to ensure timely manufacture and packaging of clinical trial material to support ongoing clinical development. Where appropriate, work must be done in compliance with current Good Manufacturing Practices (GMP). This individual must work closely with the Clinical Supplies team, Clinical Operations, Regulatory Affairs and Quality Assurance to insure that clinical supplies are available on time.
Responsibilities include, but are not limited to:
- Pre-formulation and formulation development of pharmaceutical formulations for novel, first in class compounds.
- Monitoring the manufacturing of clinical trial material at third party CROs.
- Managing primary and secondary packaging.
- Authoring CMC sections of regulatory filings.
- Ph.D. in Pharmaceutical Science, Physical Chemistry or Chemical Engineering
- Minimum of 10 years of industrial R&D experience with 5 years of experience in pre-formulation, solid formulation development and GMP manufacturing environment.
- Experience generating CMC sections for regulatory filings.
- Knowledge of modern analytical and formulation technologies and relevant IHC guidelines.
- Proficiency in Microsoft Office products.
- Ability to work independently and to manage multiple projects/timelines.
- Strong communication and interpersonal skills along with the ability to influence others.
- Ability to work with multiple internal cross-functional teams and successfully manage multiple projects simultaneously.
To apply, please visit the careers section of our website: https://lexpharmacareers.silkroad.com/.
For additional information about Lexicon and its programs, please visit www.lexpharma.com.
An Equal Opportunity Employer: race, gender, disability and veteran status
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.