Lexicon Pharmaceuticals is currently recruiting for an agile, results focused Associate Director, Drug Product Manufacturing for a limited duration assignment. The length of this assignment is projected to last 1 year.
The Limited Duration Associate Director, Drug Product Manufacturing will support the manufacture and packaging of commercial drug products of Lexicon compounds. Work must be done in compliance with current Good Manufacturing Practice (GMP) regulations. He/She will work closely with multidisciplinary functions of the organization including Regulatory Affairs, Quality Assurance, Supply Chain, as well as outside CMOs
Responsibilities include, but are not limited to:
Providing technical oversight to third party contract manufacturing sites in the routine manufacturing and packaging of Lexicon commercial products and ensuring that the drug product manufacturing is in control or capable by monitoring the critical quality attributes of each drug product and in process parameters.
Preparing or reviewing protocols, batch records, memos, reports, and regulatory documents as necessary and work with Quality Control on SOP and other policies.
Providing technical support to Lexicon’s quality organization and the third-party contract manufacturing sites in significant manufacturing process technical investigations and be able to support the third party contract manufacturer to trouble shoot and resolve manufacturing related issues.
Recommending and supporting manufacturing process improvements to drive down cost and reduce waste in the manufacturing process.
Leading or providing technical support during technology transfer activities of a new or existing molecule from one third party contract manufacturer to the other.
Providing technical leadership in monitoring and maintaining project timelines to meet business needs.
Master’s Degree in Chemistry, Pharmaceutical Sciences, Industrial Pharmacy, Engineering or related fields is required; Doctorate is preferred
Minimum of 5 years industrial experience in commercial drug product manufacturing and packaging operations, with hands-on experience in pharmaceutical manufacturing of immediate release solid dosage forms.
Familiarity with roller compactors, compression and pan coating machines is required.
Ability to review and understand executed batch records, drug product annual review data including any other drug product manufacturing charts.
Detailed understanding of technical and regulatory aspects of drug product manufacturing and packaging activities.
Proficiency with Microsoft Office Suite.
Ability and desire to work in a team-oriented environment.
Ability to travel up to 25%
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 - Females, Minorities, Veterans, and Disabled.
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.