Technical Operations Director

  •  

Decatur, IL

Industry: Biotech/Pharma

  •  

5 - 7 years

Posted 365 days ago

TECHNICAL OPERATIONS DIRECTOR

The Director, Technical Operations ensures production works with the technical operations team to provide expertise for standardizing and improving existing processes, product launches, CAPA, and support of production operations.

The Director, Technical Operations will work with cross-functional departments, manufacturing equipment, material suppliers, all to ensure that the technical needs of manufacturing is being met on a consistent basis and ultimately help ensure robust, compliant, and efficient manufacturing processes are in place. 

ESSENTIAL FUNCTIONS:1. Responsible for supporting and troubleshooting day-to-day operations, capital projects, and pipeline products in aseptic manufacturing processes.2. Responsible for process optimization for aseptic manufacturing processes and related operations3. Recommend and develop specifications for the procurement of process equipment4. Assess current processes to reduce processing times by measuring key performance indicators5. Implement process design improvements to reduce the quantity of lost batches and improved quality of product6. Work with third party vendors to implement solutions to optimize production processes.7. Deliver strategic and technical expertise to drive continuous process improvement that generate cost savings and optimize efficiencies8. Assist with design of new facilities and systems from conceptual design, specifications, budgeting, scheduling, and construction management9. Develop and implement change control for process changes10. Perform technical review of batch record documentation11. Develop documents for FAT and SAT activities for process equipment12. Participate in FAT, SAT, the startup and commissioning of process equipment after design phase. 13. Manage the life-cycle documentation of the equipment including generation and approval of user requirement14. Participate in procurement efforts for process and facility related equipment and facilitate change orders during the project15. Drive remediation work for design improvement or correction for process equipment and processes Qualifications • Bachelordegree in a technical field is preferred or 10 years of relevant experience in an aseptic filling environment.• 5+ years of aseptic manufacturing processes experience is required• Experience in process development, process optimization, and scale-up of pharmaceutical products• Experience in new product introduction, technology transfer, and process/equipment validation• Working knowledge of various manufacturing processes and unit operations including, equipment/component preparation, vial filling, terminal sterilization, formulation, and secondary packaging• Basic knowledge of process automation/control systems• Continuous improvement background with knowledge of Lean Manufacturing/Six Sigma/OE tools and techniques desirable• Understanding and application of GMP Documentation as it relates to the job function

Security Clearance Required: No

Visa Candidate Considered: No

COMPENSATION

Base Salary - $145, to $165, 

Full-time Benefits - Full 

Relocation Assistance Available - Yes 

Commission Compensation - No 

Bonus Eligible - Yes 

Overtime Eligible - No 

Interview Travel Reimbursed - Yes 

CANDIDATE DETAILS

5+ to 7 years experience

Seniority Level - 

Management ExperienceRequired - Yes

Minimum Education - Bachelor's Degree

Willingness to Travel - Occasionally

IDEAL CANDIDATE

Highly visible plant leadership role that will have direct impact the success of our business. This role is responsible for building capabilities for new product launches and process optimization in an aseptic environment. We have 12 - 13 launches on the docket with 2 ready to go currently. Will directly manage 3 and will be responsible for building a highly effective team. Candidate must have sterile injectable product manufacturing experience

$140K - $170K