Analytical Product Leader at GSK in Cambridge, MA

Within the Analytical R&D group, the Analytical Product Leader will be in charge of managing and implementing the global analytical strategy of her/his products portfolio (2-4 projects), in alignment with the GSK Vaccines R&D and TRD strategies, and in accordance with Quality by Design (QbD) principles.

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

Deliver and implement the consolidated global analytical strategy of her/his products portfolio (2-4 projects), in alignment with the GSK Vaccines R&D and TRD strategies, and in accordance with Quality by Design (QbD) principles.
Influence the success of Analytical Technical Development by being one voice of ARD with TDT, RA and QC from early through late stage and life-cycle management.
Accountable for the methods development according to the Analytical Target Profile (responsibility for SM Dev) and the GMP release and stability testing plan, through both the Analytical Development platforms and the GMP unit.
Manage the product understanding (characterization) of clinical phase 1-2 and Phase 3, commercial products and LCM
Manage the analytical support to process understanding (antigen and product characterization needs) with other TRD functions using state of the art technologies for analytics and data interpretation
Manage the critical material and reagents strategy and ensure their availability in due time
Raise and manage any risk/issues on critical path to TDT and to ARD functions (budget, capacity, technical)

Why you?

Basic Qualifications:

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

Ph.D. in biological, analytical , or pharmaceutical chemistry, or similar science/engineering field with 5+ years in analytical development.
OR MS in biological, analytical , or pharmaceutical chemistry, or similar science/engineering field with 10+ years in analytical development.

Preferred Qualifications:

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

Experience with product characterization of vaccines drug candidates and/or recombinant proteins, monoclonal antibodies, fusion proteins, conjugates.
Strong influencing and communication skills
Experience leading/managing in a matrix team or having had direct reports
Experience in technology transfer in manufacturing
Ability to work with cross-functional teams and communicate effectively
Sound scientific methodology and thinking

#LI-GSK

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.