The Associate Director, Manufacturing Operations Support- MSAT will be the primary lead for the newly formed Technical Execution Team which holds strong accountability in enabling successful manufacture of commercial assets at the Rockville commercial facility.

You will be accountable to drive and coach a team to drive continuous improvements of existing bioprocesses as well as supporting day to day operations with activities like CAPAs, Change Controls, Product Impact Assessment and deviations support for a 20kL facility and a 10kL facility. You will work in a highly cross-functional matrix environment and will support the product owner team lead to develop strategy for complex global CMC submissions and drive on time execution.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Provide mentorship and coaching to develop a high performing teams of engineers and technical managers who support different commercial products in two different facility within the Rockville site
• Proactively works with colleagues in manufacturing, engineering and quality to provide technical solutions to complex questions related to DS bioprocessing
• Establish plans for hands-off between manufacturing, engineering and MSAT
• Ensures implementation of technically sound CAPA in collaboration with colleagues in quality, manufacturing and engineering
• Manages the Change Control MSAT portfolio, provide technical oversight to deviations and product impact assessment to enable prompt resolution and prevent reoccurrence
• Support RCA and DMAIC exercises during investigation or in support of business processes improvements
• Identify and implement continuous improvement (including yield improvements, enabling aseptic operations)
• Effectively deploys resources to troubleshoot and mitigate on the floor issues as needed, support campaign restart and shutdown
• Owns and drives site feasibility assessment to evaluate introduction of new assets into the site

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:​

• Bachelors degree
• 15+ years of experience in biopharmaceutical process development, MSAT or CMC roles
• Experience with current trends in the industry, ICH Guidelines and GMP principles at commercial scale
• Experience with CAPA, Change Controls and Deviation supports
• Prior experience with operational excellence principles and business processes improvements
• Experience and understanding of bioprocessing principle for DS bioprocesses: able to troubleshoot processes both for upstream and downstream

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Strong leadership skills, ability to multitask and drive a team towards goal
• Strong interpersonal and leadership skills. Committed team player prepared to work in and embrace a team-based culture.
• Lead a team to provide impact assessment to deviations and RCA
• Strong Executive Presence and influencing skills are a must
• Strong sense of urgency, capability to question status quo and find non ordinary solutions to complex problems
• Strong executive presence, able to influence cross-functionally and drive improvements
• Accountable for identification and implementation of  continuous process improvement
• Able to interact well cross-functionally within the site and with multiple stakeholders out of the sites, in and out of GSC organization (GRA, global compliance etc.).
• Strong verbal and presentation communication skills which emphasize teamwork with a strong quality orientation.
• Strong capability to prioritize effectively and deploy resources to ensure prompt resolutions to day to day issues.
• Thorough understanding of bioprocesses for DS manufacturing

#LI-GSK

The annual base salary for new hires in this position ranges from $136,950 to $228,250 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

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