Title: Sr. Manufacturing Expert
Salary: Highly Competitive
One of the industry's leading pharmaceutical manufacturer of clinical supplies is looking to bring on a Sr. Manufacturing Expert to their Pilot Facility in Fort Worth, TX. You will be a part of the Technical Research & Development team, making sure that sterile clinical supplies are manufactured to the highest quality aseptic standards, ensuring our patient safety in clinical trials. You will manage at least 10 projects at a team.
The Sr. Manufacturing Expert is responsible for…
- Provide technical expertise and direction in cGMP processes and procedures of aseptic production for the successful completion of each batch of clinical supplies
- Work cross functional with project and operations teams
- Be the liaison for the Pilot Facility for technical discussions and play a key role in manufacturing readiness to ensure that the team is prepared to proceed with production
- Lead all investigations related to all aspects of aseptic production of clinical supplies
- Lead the team through discovery phase for root cause analysis, assist with definition of appropriate CAPAs and finally define effectiveness checks to prevent future repeat incidents.
- Work with the QA and project teams in the completion of batch record documentation, with strict adherence to GDP and cGMP, and ensure the safety and efficacy of each batch prior to release for use in patients
- Maintain processes at inspection readiness level and provide support in any internal or external audits
- Suggest productivity enhancements to allow for more efficient batch production that does not sacrifice quality or safety
- Present lessons learned from each manufacturing campaign
- Work accordingly to all SOP's, cGMP, Quality Directive, Quality Manual, Health Safety & Environmental guidelines, and company guidelines.
The Sr. Manufacturing Expert should have the following qualifications:
- Degree in Pharmaceutical, Life Sciences or equivalent. PhD, PharmD is preferable.
- Fluent English orally and verbally
- 5+ years demonstrating competency in a similar role in an aseptic manufacturing plant making clinical or commercial drug products
- Knowledge of instrumentation/equipment of aseptic production of simple solution, complex suspensions, and emulsions.
- Experience in non-sterile topical production instrumentation is beneficial
- Strong communication skills, presentation skills, and scientific/technical writing skills
- Advanced coaching and servant leadership skills