Here at GSK, Product Owners are the single point of accountability for product lifecycle and CMC strategy/ execution for the biopharmaceutical assets manufactured at the commercial Rockville facility. In this role, as an Associate Director, Product Owner Lead you will be leading a team of product owners accountable for establishing and updating control strategy, identify continuous process improvements and drive CMC Submissions and agency interactions.

The individual will work in a highly cross-functional matrix environment and will lead product owners' team 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:

Coach and mentor a team of product owner; drives technical agenda and develop capabilities
Ensure products have appropriate control strategy and makes update as necessary
Main accountable for authoring CMC dossier and HAQs for US and ROW markets
Ensure content of CPV report, protocols and annual PPR is strategically appropriate and accurate
Provide oversight and guidance to CPV meetings
Identify opportunities for continuous improvements
Works cross-functionally with Global Molecule Stewards, Global Regulatory and Global Quality parters, as well as internal site functions
Provide strategical oversight to a variety of CMC and LCM activities

Why you?

Basic Qualifications:

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

Bachelors degree
10+ years industrial 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 in CMC technical writing field with complex regulatory submission and response with a variety of Regulatory Agency (FDA, EMA, JP, China etc.)
Prior regulatory experience required, authoring and approving complex submissions and supporting agency interactions
Strong understanding and experience with Process Validation and Control strategy
Experience working within bioprocesses for DS (upstream and downstream)
Prior experience supporting inspections and audits

Preferred Qualifications:

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

PHD highly preferred
Strong sense of urgency, ability to work under pressure and questioning status quo
Ability to challenge status quo, design new ways of working
Demonstrated ability to deliver complex projects end-to-end
Ability to manage cross-functionally a variety of stakeholders, influence and drives decisions
Demonstrate ability to work in a cross-functional, matrix environment and understanding of governance roles
Strong executive presence and executive presentation skills are required in this role
Strong interpersonal and leadership skills. Committed team player prepared to work in and embrace a team-based culture.
Ability to challenge status quo and identify new solutions and ways of working
Able to interact cross-functionally within the site and with multiple stakeholders out of the sites, in and out of GSC organization (GRA, global compliance etc.).
Outstanding verbal and written communication skills which emphasize teamwork with a strong quality orientation.
Demonstrated technical CMC writing skills.
Thorough understanding of bioprocesses for DS manufacturing
Demonstrated experience with commercial manufacturing, NPI and commercial launches
Strong leadership skills and executive presence

#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.

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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