Biologics Process Validation Leader

Rockville, MD, USA GlaxoSmithKline Site Name: Rockville Biopharm

Posted Date: Apr 8 2024

Are you energized by a scientific leadership role that allows you to enhance and improve processes across biopharmaceutical manufacturing? If so, this Biologics Process Validation Leader role could be an ideal opportunity to explore.

As a Biologics Process Validation Leader, you will be responsible for technical leadership of important program s of work to support lifecycle changes . The role provides leadership across process sciences, a CRO, an NPI or commercial site, or a CDMO to ensure that the studies are completed to the latest regulatory, cGMP requirements and time and cost. The Biologics Process Validation Leader is responsible for cell culture and purification process stretching studies, resin lifetime studies, buffer/solution hold time studies, at-scale membrane and resin lifetime verification studies, virus clearance studies, limit of in-vitro cell age studies, preparation for the regulatory files, PAI and support through the product lifecycle including knowledge management.

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

Uses regulatory guidance and industry best practice, and scientific and technical experience, to develop innovative approaches to process or viral clearance validation.

Plans, executes and reports process or viral clearance validation studies through process sciences, CROs, internal NPI or commercial DS sites or strategic CDMOs.

Authors regulatory submissions, responds to health authority information requests and presents at pre-approval & cGMP inspections as necessary.

Participates in deviation, change & continuous improvement evaluations in support of continued lifecycle verification.

Participates in the development & implementation of new process and analytical manufacturing technologies in support of biologics DS processes.

Manages CRO or CDMO contracts, and the effective management of expenditure and effort in support of process or viral clearance validation studies.

Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate .

Provides technical leadership and establishes key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and also with R&D.

Why you?

Basic Qualifications:

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

BSc in Scientific Discipline

Minimum 5 years' demonstrated experience in the Pharmaceutical Industry in leading the technical aspects of the product lifecycle, including technical risk assessments, product control strategies, bench, pilot & commercial scale validation studies, QbD, PPQ, CPV and change control.

Preferred Qualifications:

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

Experienced in process validation at commercial scale and bench scale.

Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.

Excellent problem solver and ability to think and work creatively.

Demonstrated knowledge of Quality by Design and risk management approaches.

Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.

Broad and integrated knowledge that can impact project and workgroup direction. Working knowledge of regulatory requirements in the industry and drug development.

Must have excellent verbal and written communication skills, and ability to influence, lead and drive change.

Experience in program management, process validation, BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, change and deviation management), and knowledge management.

Ability to support due diligences .

#LI-GSK

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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