Manager – Technical Services - Pharmaceutical

Summary: 

·         The Manager of Technical Services provides oversight and expertise primarily in the areas of pharmaceutical process engineering and technical transfer. 

·         This position will manage large scale projects and multi-disciplinary teams. 

·         The Manager will also provide technical direction for complex projects and exhibit superior communication skills with all levels of employees. 

·         The individual will be responsible for refining department and site processes and provide leadership. 

·         Process Engineers will report directly to Technical Services manager.

Note 1: This person will have around 5 technical staff reporting to this role working Weekend shift. This role will report to the Assoc Dir of Technical Services. 

Note 2: Weekend Day shift. 10 hours each for 4 days from Fri. – Mon. Shift differential adder pay + 7.5%

Note 3: The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4th line at this growing plant site. 

Note 4: Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa. 

Job Description: 

Oversee design, optimization and implementation of site manufacturing processes to improve efficiency, quality and sustainability
Oversee and assess existing processes and workflows
Lead team to establish and track process metrics to monitor process stability and discover areas for improvement
Oversee Technical Transfer of new products from both internal and external clients
Drive team ownership of product processes from initial quote to product retirement
Evaluate incoming processes for robustness, efficiency.
Lead team to perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing.
Review and approve validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product.
Oversee development and execution of validation studies to test and qualify new and improved manufacturing processes.
Lead team through troubleshooting, oversight and/or sampling of events within Manufacturing; will require occasional off-shift at-location or remote support.
Review and approve reports summarizing results of studies to document data collected; overview utilization of data obtained to qualify site processes.
Review and approve protocols, SOPs, reports, deviations requiring Technical Services approval.
Oversee team review of data summaries generated by other departments, assessment of the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted.
Oversee and participate in or perform deviation investigation and evaluation of impact
Ensure team implements effective CAPAs
Provide necessary reviews for regulatory and client audits and provide responses to audit observations
In-depth understanding of cGMP’s, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.
Perform all supervisory duties for exempt level Process Engineers. Assign daily work, hiring, performance management, training and other managerial duties.
Write and manage department SOP’s, training etc. to ensure regulatory compliance and operations enhancement.