Technical Services or Operations or Support Manager (Pharmaceutical)

Responsibilities:

· Understand, organize, and perform process validation in accordance with company and regulatory requirements.

· Execute study protocol

· Prepare data summary

· Hands on experience in operating lab and manufacturing equipment.

· Receive direct supervision from manager or engineer.

· Prepare formulations and perform physical testing for the product

· Responsible for process validation, process optimization, scale-up, technology transfer.

· Prepares process validation protocol and summary reports.

· Prepare and revise commercial MBR

· Collaborate and communicates effectively with PD, QA, QC, Manufacturing and Engineering departments.

· Provide trouble shooting efforts (process & equipment) to support Manufacturing.

· Prepare study protocol to design and undertake quality scientific experimentation for the purpose of trouble shooting, scale up study or process optimization.

· Provide technical assessments in investigation reports.

· Conduct investigation to seek the root cause of deviation, OOT and OOS.

· Recommend the resolution from the investigation results, prepare the investigation report and implement the CAPA items.

· Review and approve process and equipment procedures and documentation per change control procedures.

· Develop relevant SOPs

· Provide training to associate or junior engineer

· Product maintenance.

· Must work independently and manage multiple process validation projects, re-qualifications and change control issues.

· Write, review and approve various levels of documentation

· Be able to develop and build scale up models. 

· Hold knowledge of Six Sigma and/or other statistical process control techniques and their requirements for the implementation during the process development. 

· Be able to work in the laboratory, guide the conception and implementation of creative solutions to solve technical problems. Interpret results of experiments and make recommendations for process improvements that reflect understanding of regulatory requirements, business objectives, and cost implications.

· Supervise and train associate or engineer.

· Develop and maintain positive working relationships with other groups

· Keep informed of industry trends, developments and new products in related process optimization and scale up.

· Take initiatives to improve production efficiencies, reduce cost of goods and optimize cycle time.

· Provide recommendation for the policy implementation.

· Support IMPAX Lab’s Quality System.

· Other duties as assigned.

 

Requirements:

·  Bachelor's degree in chemical engineering, pharmaceutics, or related science discipline and over 5 years of related experience, OR

·  Master's degree or Ph.D. in chemical engineering, pharmaceutics, or science discipline; 2-6 years experience with MS or 0-5 years experience with PhD

·  Thorough knowledge of cGMP's and state-of-the industry practices in cGMP compliance.

·  Strong verbal, presentation and technical writing skills.

·  A proven track record of process development, process optimization and technology transfer experience.

·  Effectively facilitate for positive conflict resolution.

·  Ability to work with cross functional team and meet performance commitments