WuXi AppTec

Manager, Engineering

Job Locations US-CA-San Diego
Job ID
2021-8389

Overview

The position will be responsible for managing the safe execution of chemical processes in the Kilo-Lab (Process Room suites) and Pilot Plant in compliance with cGMP regulations. The candidate will work with a team of operators in conjunction with PR&D and Analytical Chemistry Departments and assist in developing safe, efficient and easily scalable processes for producing raw materials, starting materials, intermediates, and active pharmaceutical ingredients (API’s), along with Powder-in-Capsule (PIC) products. In addition, the candidate will work with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process development and campaign reports including batch production records (MBRs/EBRs) are completed in a timely manner. This position has overall responsibility for keeping the Kilo Lab and Pilot Plant equipment and suites functional and compliant. The ideal candidate will have shown proficiency in hands-on chemical manufacturing and process safety work, the ability to manage activities and solve challenges, extensive experience reviewing and organizing chemical production data and leading a chemical production/engineering team. The position requires a strong background in drug substance production, as well as thorough knowledge of relevant equipment and cGMP, ICH and relevant FDA guidelines. CDMO experience is beneficial.

Responsibilities

  • Supervises execution of chemical processes in the Kilo Lab and Pilot Plant suites.
  • Provides technical and trouble-shooting support for Kilo Lab and Pilot Plant processes.
  • Manages production schedule in the Kilo Lab and Pilot Plant, as well as determines staff and equipment resources.
  • Has oversight of process safety.
  • Interacts with PR&D, QC, Materials Management and Quality Assurance in a manner as to achieve common goals.
  • Works with PR&D staff to develop safe, efficient, and easily scalable chemical processes.
  • Ensures that repairs and updates to the Facility, Kilo Lab and Pilot Plant equipment and suites are carried out as needed (in conjunction with the Facilities team).
  • Interacts with equipment/material vendors.
  • Evaluates current procedures and equipment for continuous improvement.
  • Trains Operators, Engineers, Technicians and other staff to be competent in cGMP, Process Safety, as well as the chemical processes to be carried out per the specific batch records.
  • Maintains production schedule to meet customer and business goals.
  • Ensures cGMP compliance of the Kilo Lab and Pilot Plant equipment and suites, as well as the corresponding production processes and products.
  • Plan all production needs, including but not limited to ordering all materials needed ahead of production, preparation of master batch records, equipment and production suites readiness.
  • Communicate with clients to meet their needs.

Qualifications

Experience / Education   

  • Bachelors Degree in Chemical Engineering, Chemistry or a related discipline
  • 8-+ years of relevant experience. 
  • 1+ years of managing people, performance management, and mentoring/ coaching employees
  • Demonstrated understanding of cGMP manufacturing for APIs and PIC DPs.

 

Knowledge / Skills / Abilities:

  • Demonstrated capability in organic chemical process development, scale-up, Pilot Plant processing operations, and cGMP operations. 
  • Must be familiar with the use and maintenance of large-scale chemical processing equipment (reactors, filters, ovens, mills, etc.).
  • Demonstrated success working effectively outside defined scope of responsibility, when required.
  • Possess strong project management and supervisory skills while maintaining high quality and efficiency standards.
  • Supervise, mentor, and inspire direct reports to enable them to be productive contributors and facilitate their technical and career growth.
  • Provide regular updates, documentation and communication of Operations activities to internal teams, clients and management as needed.

 

Physical Requirements:            

  • Must be able to work in production and lab setting with exposure to chemicals.   
  • Must be able to wear appropriate PPE.
  • Must be able to work in environment with variable noise levels.

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

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