- Published on 08 Nov 2023, 3:20 PM
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Sterling Life Sciences Petersburg, United StatesJob DescriptionOur client, a leading pharmaceutical company, is currently recruiting a Director of Manufacturing Sciences and Technology who will infuse the Director of Manufacturing Sciences and Technology Team with their talent, energy and leadership skills. This is an exceptio ...
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Director of Manufacturing Sciences and Technology - Petersburg, United States - Sterling Life Sciences
Description
Job DescriptionOur client, a leading pharmaceutical company, is currently recruiting a Director of Manufacturing Sciences and Technology who will infuse the Director of Manufacturing Sciences and Technology Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:
1) Direct the transfer of sterile injectable production processes and technologies from R&D into site operations
2) Build a small but capable organization of process engineers/scientists to transfer manufacturing processes from R&D to operations
3) Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems
4) Co-own the site tech transfer process and SOP with R&D
5) Charter cross-functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations
6) Work with the site leadership team to build subject matter expertise across functions in the areas of compounding, sterilization, and single-use assemblies for filtration and filling, device assembly, and visual inspection
7) Be accountable for site process control strategy document, technical transfer change controls and protocols and ensure that the manufacturing batch record meets established conditions as defined in the CMC documentation
8) Support product preapproval inspection, including direct interaction with regulatory agencies during site inspections
9) Review and approve cGMP documents, such as batch records, technical protocols and reports, change controls, deviation reports, validation protocols, and summary reports
10) Work closely with both functional and project managers to identify and mitigate technical issues and manage project milestones to adhere to project timelines.
11) Serve as a key member of the site leadership team by supporting site initiatives, providing input to the site strategic direction and supporting matrix leadership across other core business functions
12) Oversee product technical lifecycle management with regards to process control strategy process/yield improvement, process knowledge management, batch deviations, and ensure accuracy of regulatory CMC registration detail
13) Provide technical leadership for the rapid resolution of technical issues impacting supply through product performance investigations and use of root cause analysis tools and appropriate CAPA and escalate key site technical issues
Critical Requirements
1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceutical industry is strongly preferred
4) Preference will be given to candidates with recent experience in manufacturing management
For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.
Compensation and Other Details
Base Salary: Highly competitive package, commensurate with experience
