Senior Specialist, Quality Control

Job Description

Position Overview - Basic Functions & Responsibility 

A robust analytical testing network is essential to realize our company’s mission and strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial product.  The Senior Specialist, BCR Sciences is an individual contributor role accountable for critical reagent evaluation and qualification activities to realize uninterrupted supply of well-performing, qualified reagents for our Company’s growing inline large molecule product portfolio.   

Effective communication and teamwork with internal and external partners are essential to the success of this role. The role is expected to participate in effective cross-divisional collaborations at both local site and global levels both with internal and external collaborations.  Given the scope, this role requires strong technical expertise in general analytical laboratory operations, equipment and techniques.  

The ideal candidate for this position will have significant working knowledge of GMP data/documentation as applied in a QC laboratory or analytical support function.  This role will require strong communication and collaboration skills in addition to technical competencies in analytical platforms and data analysis.  Planning and organizational skills to ensure effective communication with stakeholders (within and beyond Large Molecule Critical Reagents organization) are required. Additionally, the candidate will be responsible for technical problem solving and collaboration with planning and analytical sciences teams to ensure work priorities are aligned with short/long term-reagent supply.  This role will also strive to optimize legacy vaccine qualification practices while being aligned with approved capital investments for enhanced operational and digital capabilities.  

Primary Activities

As a BCR Sciences Senior Specialist for Large Molecule Biologic Critical Reagents, this role is accountable for the following:

• Provide ownership and accountability for critical reagent deliverables (e.g. qualification, re-certification, troubleshooting) which will include cross-functional support from BCR scientists, Analytical Sciences, LMAS scientists, CMC Regulatory, as well as AR&D scientists.

• Complete the above work activities by target dates as per Large Molecule (LM) Critical Reagents S&OP process and aligned cross-functional integrated work plans (issued/approved by the LM Critical Reagent Planning and Controls team and based on collaboratively established, realistic standard lead times for core work activities).

• Rapidly escalate and resolve issues through tier process.

• Encourage team cu