Reference #: 402667 Site Name: Home Worker - USA, USA - Maryland - Rockville, USA - Massachusetts - Boston, USA - Pennsylvania - Philadelphia Posted Date: Aug 15 2024

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.

At GSK we have a large pipeline of vaccines and we are expanding our capacity and capabilities internally and externally to meet the increasing need in the CMC development space. We therefore look to increase our alliances with external partners to accelerate product and process development and the introduction of new vaccines

Drug Product (DP) is one of the core functions of GSK Technical R&D, accountable for vaccine product and process development from the early onset of discovery projects and platforms to late-stage development, transfer and launch of new vaccines.

The Director, Drug Product Strategic Alliance defines, leads, and transversally coordinates external strategic partnership for DP CMC development, ideally matching with the clinical material manufacturing footprint, and creating a network of trusted partners to execute delivery of robust, fit for purpose product and process development.

Key Responsibilities:

Manage multiple drug product external development efforts for vaccine drug product programs within GSK's development portfolio.

Build strong internal and external relationships with key stakeholders to help facilitate the delivery of DP objectives. Facilitate a highly cross-functional internal and external CMC team environment through engaged leadership, collaborative interactions and a data driven, quality focused mentality.

Provide direction and oversight for process development/scale-up/transfer activities at external development sites.

Provide leadership to ensure scientific excellence in study design, data collection and interpretation, and management within scope to prospectively agreed objectives, budget and timelines.

Provide critical analysis of program challenges and opportunities and recommend mitigation plans where necessary.

Support/lead and/or coordinate joint technical investigations connecting partners to internal experts to secure a path forward for programs

Assist project management to proactively build detailed CMC timelines with clarity on assumptions, risks and decision points.

Prepare and keep current written CMC development strategies in alignment with overall program objectives. Present results and progress of CMC programs to internal and external audiences as appropriate.

Coordinate the evaluation of external and internal technologies,encompassing formulation, delivery systems, manufacturing platforms, to ensure strong decision-making on externalization.

Lead the strategic alliance in collaboration with R&D functions, Legal, IP and BD departments, with relevant stakeholders/customer functions.

Serve as a member of the global Drug Product leadership team, contributing to the strategic vision and collaborating across the TRD global network.

Collaborate effectively with the internal DP Development units, to build an externalization framework where DP project leads from the development units can operate and secure the project deliverables.

Apply Quality by Design (QbD) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of drug product formulation and manufacturing process with the external partner.

Secure investment to progress through creation of business cases.

Basic Qualifications:

PhD in chemistry, biology, bioengineering or pharmacy

5+ years of experience in the Drug Product technical development area

Experience in delivery systems, product pre-formulation and formulation

Experience in Late and/or Early process development

Preferred Qualificatio s:

Demonstrated ability to design, manage and deliver on complex projects in the field of science and technology

Experience leading a team of scientific experts across multiple sites

Knowledge of Vaccine manufacturing environment

Understanding of external key players in the field

Experience leading a matrix team

Learning agility, high level of autonomy and desire to learn new things outside of one's comfort zone

Experience in transversal function or team management

Strong leadership and communication skills

#Vx-Cam

#Li-GSK

The annual base salary for new hires in this position ranges from $172,550 to $233,450 , taking into account a number of factors including work location, 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.The annual base salary for new hires in this position ranges from $172,550 to $233,450 taking into account a number of factors including work location, 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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