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, you will be accountable for authorizing complex CMC regulatory submission, sustain agency interactions as well as supporting overall product lifecycle management and process improvements initiatives.

As a Product Owner, 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:

Ensure product has an appropriate control strategy (technical RA, PAR/ NOR), propose revisions and updates as necessary
Main responsible for authoring CMC dossiers and HAQs for US and ROW markets
Accountable for identifying yield improvements initiatives and work with technical execution team to drive implementation
Proactively conduct CPV and trend relevant process parameters in collaboration with automation and CPV SME in the MSAT Technical Standard team
Authors CPV reports and protocols under the guidance of the Technical Standard team
Accountable for annual Product reviews
Serve as part of the GSK technical community, providing input to technical discussions and cross-site collaborations

Why you?

Basic Qualifications:

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

Bachelors degree
7+ years industrial experience in Biopharmaceutical process development, MSAT or CMC roles
CMC technical writing skills
Understanding and experience with Process Validation principle, experience with commercial products Control Strategy
Experience with complex regulatory submission and response with a variety of Regulatory Agency (FDA, EMA, JP, China etc.)

Preferred Qualifications:

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

Strong understanding of bioprocessing principle for DS bioprocesses
Demonstrate ability to work in a cross-functional, matrix environment and understanding of governance roles
Deep knowledge and understanding of current trends in the industry, ICH Guidelines and FDA/EU validation practices for biopharmaceutical processes at commercial scale
Ability to manage cross-functionally a variety of stakeholder
Strong interpersonal and leadership skills. Committed team player prepared to work in and embrace a team-based culture.
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.
Strong technical writing in CMC environment.
Thorough understanding of bioprocesses for DS manufacturing
Demonstrated experience with commercial manufacturing, NPI and commercial launches

#LI-GSK

The annual base salary for new hires in this position ranges from $110,550 to $184,250 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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