Associate Director of Technical Operations in Albuquerque, NM at AMRI

Date Posted: 11/3/2018

Job Snapshot

Job Description

Associate Director of Technical Operations
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 
Summary:
Associate director, Technical Operations is responsible for the technical support (equipment, process, and employees' knowledge base) of the facility. They also support members of the group by assisting in technical support in all areas of the facility. The associate director of technology operations is responsible for oversight facility priority projects. The position is fully responsible for: mentoring, growth and development, performing reviews, hiring, disciplining, and terminating those employees reporting to them or their direct reports.
The associate director is responsible for AMRI sterile university which is responsible for the training of employees on tools and skills, as required or suggested. Training personnel in new processes or process enhancements, as required.
Essential Duties and Responsibilities:
  • Responsible for rapid change and process improvements in specified production areas with the use of LSS, as required or suggested throughout the facility. This includes overseeing managers, specialists and engineers responsible for all areas in the Operations department which are responsible for the following:
  • Use data analyzing tools to evaluate data collected from the processes in your area to evaluate and maintain the processes.
  • Create and maintain control charts, and trending data, from your assigned area to communicate process controls and improvements.
  • Have ownership of your area including the processes and equipment within the area.
  • Conducting area evaluations for equipment and process improvements utilizing LSS tools and processes, as required or suggested.
  • Responsible for value stream mapping of production areas, equipment and processes.
  • Support Highly Potent Compound initiatives.
  • Implements improvements to the Operations process and equipment related to their area of responsibility.
  • Maintains a floor presence to continually look for areas of improvement and provide support to the Operations Department.
  • Support daily activities in your area of responsibilities (including asking the manufacturing team routinely (daily-weekly minimum) what their needs area).
  • Investigate delays, trends, equipment issues and items that adversely impacting product capabilities in your area.
  • Trend PR and equipment issue within your area to effectively address problems.
  • Must be able to work on equipment and write procedures for your area.
  • Able to work flexible hours as needed to support area of responsibility
  • Be considered an expert and go to person for more than one area or specialty within the facility.
  • Supervise, mentor and develop other Specialists within the Tech Ops group. Assist other Specialist and support training of Specialist.
  • Required to provide support and the basic tools required to equip employees with the appropriate knowledge for functioning in your area of responsibility.
  • Creates documents for Operations processes and develops strategies for improving the performance of the Operations Department.
  • Manage the tech transfer of new products or processes into the facility and coordinates, assists and oversees purchasing of equipment for the company which includes:
  • Identifies and analyzes new technologies that may be beneficial to the company.
  • Writes User Requirement Specifications for new equipment / technology.
  • Writes protocols for commissioning new equipment as well as other validation related projects (as required).
  • Conducts Factory Acceptance Tests, Site Acceptance Tests, Commissioning Tests and Machinability Runs for new equipment (as required).
  • Support validation activities.
  • Completes change controls related to MBRs, SOPs, PRs, compliance, new products, equipment changes/enhancements, and process improvements.
  • Participates in, or leads, Operations Excellence projects (i.e. Black Belt projects, Green Belt projects, Kaizen events), which includes the following:
  • Actively pursue LEAN of processes and improvements (minimum of 1 project at all times)
  • Apply LSS tools to investigation and Problem Reports, as required or suggested.
  • Monitors and reports progress of projects within agreed timelines ensuring goals are met.
  • Responsible for maintaining up-to-date timelines and meeting agreed upon deadlines.
  • Consults and advises upper management of project status and reports issues that may affect ultimate results.
  • Must be able to manage multiple projects at the same time.
  • Works with customers, Project Managers, Tech Ops, Operations Excellence, Operations, Maintenance, and Engineering to coordinate activities in accordance with planned schedules, customer specifications, and established quality standards.
  • Address not only tactical everyday issues but also strategic site wide issues and future objectives.
  • Support Department and facility goals & objectives for long term growth.
  • Manage the priority of the group and communicate needs to the facility.
  • Cover gaps within processes and systems throughout the facility as needed.
  • Must share resources with other business units as needed and when available.
  • Must be able to quickly address manufacturing concerns to assist operation in maintaining schedule.
  • Responsible for reviewing all SOPs for completeness, content and clarity, and performing training. Responsible for ensuring compliance with cGMPs, corporate and site-specific policies, and procedures.
  • Able to work with little or no guidance or support to improve equipment and processes.
  • Able to leverage the Tech Ops team and resources around you to be more successful.
  • Able to think rationally about issues, obstacles and concerns to make appropriate decisions and evaluate to a high level when required.
  • Exercises judgment within broadly defined practices in selecting techniques and solutions. Demonstrates success in technical proficiency as it pertains to OsoBio systems and practices, collaboration with others and independent thought.
  • Obtain training and certification in Lean, Lean Six Sigma or Six Sigma (or provide evidence of prior certification and/or training)
  • Must be gown qualified and media qualified and maintain certification.
  • Maintains up-to-date training, including safety.
  • On Call 24/7
  • Other tasks as required to assist other departments and the company.
Supervisory Responsibilities:    
Manages two subordinate supervisors who supervise up to four employees in the Tech Ops Group 1 and Tech Ops Group 2. Is responsible for the overall direction, coordination, and evaluation of these units. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Job Requirements

Education and/or Experience: 
Bachelor's degree (BS) from four-year college or university in scientific field or business and minimum 5 years directly related experience in the industry or equivalent combination of education and experience (2 years’ experience equal to one year of education).
 
Language Skills:
 
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Mathematical Skills:
 
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability:
 
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. 
 
Computer Skills:                                             
To perform this job successfully, an individual should have knowledge of Internet software; Manufacturing software; Project Management software; Spreadsheet software and Word Processing software.
Other Skills and Abilities:                                           
  • Solid knowledge of a sterile processing environment Proficient with Windows, Microsoft Word, MS Project, Excel and Minitab computer programs.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Ability to perform independent work related to projects and/or routine activities.
  • Ability to be an author for protocols or reports, or other non-routine activities.
  • Ability to review reports, etc. for accuracy and logic.
  • Ability to meet deadlines and work under pressure.
  • Ability to effectively lead or work on a team to accomplish goals.
  • Ability to learn independently about equipment and processes.
  • Ability to work collaboratively with many departments and personalities.
  • Ability to be self-motivated.
     
    Certificates, Licenses, Registrations
    Must be able to obtain and maintain gowning qualifications.

Shift:  Standard 8

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

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AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.