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Manager - Development - QA (EZIJP00002615)

Job Title:

Manager - Development - QA (EZIJP00002615)


Exton, PA




12 month minimum

Job Description:

Overview / Responsibilities

Biologics Manufacturing Person-in-Plant and Investigation Support.

The Manager, Development Quality Assurance (Biologics) acts as the primary Person-in-Plant (PIP) for Bulk Drug Substance (BDS) manufactured at the Client's Biologics Pilot Plant (BPP). The Manager reviews, and may also assist in, investigations conducted by Operations personnel, for process, product, equipment, and system deviations that occur within the BPP, including support systems such as Water-for-Injection (WFI) and other utility systems.

The individual will ensure meaningful, root-cause directed CAPA are identified and will be responsible for Effectiveness Checks of those CAPA. Specifically, this person will contribute to the success of the overall operation by ensuring that all material produced at the BPP is fit its intended use and deviations have been adequately investigated for product impact and good documentation practices. 

This role works closely with all BPP team members, both within DQA and across the organization, and at all levels of the organization (ie, from entry level to President). This role will also interact with personnel from outside organizations, typically CMO. The role is highly visible and critical to the overall success of the BPP operation.


Act as Quality representative for PIP role for on-site BDS manufacturing 
Review, and at times assist in investigating, process, product, equipment, and system deviations typically related to BDS manufacturing and associated systems at the Pilot Plant and CMO to ensure meaningful, root-cause directed CAPA are identified and adequately documented, and author associated Effectiveness Checks for those CAPA. 
Review and edit Change Management TrackWise records including Implementation Activities.

Responsible, as lead PIP person, to ensure BDS is manufactured to high Quality standards and is fit for its intended use. Responsible to ensure investigations are adequately conducted and documented, to ensure impact to product is properly identified, to ensure CAPA are appropriate and proven effective, and equipment and systems continue to operate in a validated state.

These activities will be critical towards establishing a highly safe, compliant, and quality operation that can help deliver an uninterrupted supply of investigative medicinal products and future commercial material. These products have the capability to support multiple clinical trials on a global basis.

Job Requirements:


• Minimum of a BS degree in a Life Science discipline or Chemical, Biochemical or Mechanical engineering 
• A minimum of 5 years hands-on experience in a GMP biopharmaceutical/pharmaceutical production environment 
• Knowledge and experience with larger scale cell culture, downstream processing, SIP, CIP, clean room operations, and single use systems is required. 
• Demonstrated ability to review complex investigations for compliance gaps and to perform root cause analysis. 
• Strong verbal, presentation and technical writing skills mandatory. 
• Knowledge of US, EU, and Japanese regulations and GMP guidelines 
• Experience with Microsoft Office Word, Excel, SharePoint, and TrackWise strongly desired 
• Position works in office environment and assignments will require work in a production core, testing, utilities, and facilities environments within the manufacturing facility

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