Senior Manager, CMC RA Vaccines Development Projects
Business Introduction 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. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives.
GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.
We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary You will lead CMC (Chemistry, Manufacturing and Controls) activities for vaccine development projects in the United States.
You will work closely with cross-functional teams including regulatory, clinical, quality, manufacturing and external partners. We value clear decision-making, collaborative problem solving, and hands-on delivery. This role offers growth through complex technical challenges and visible impact on project success, aligned with our mission of uniting science, technology and talent to get ahead of disease together.
Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Lead development and execution of CMC project plans to support clinical development and regulatory submissions for vaccine candidates. - Coordinate technical input across quality, manufacturing, analytical development and regulatory to enable timely deliverables. - Identify, assess and manage CMC risks and mitigation plans that affect project timelines and regulatory acceptance. - Prepare, review and approve CMC documentation for regulatory filings and meetings with health authorities in the US. - Represent the CMC voice in cross-functional project meetings and drive decisions to resolve technical or programmatic issues. - Mentor and coach team members, and support capability building across the project team.
Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: - Bachelor’s degree in life sciences, engineering, chemistry or a related discipline. - At least 7 years of CMC experience within biologics or vaccines development or manufacturing. - Experience preparing and managing CMC sections for regulatory submissions in the US. - Practical knowledge of manufacturing, quality and analytical development for biologics or vaccines. - Demonstrated project management skills delivering complex programs with multiple stakeholders. - Strong communication skills with a track record of influencing cross-functional teams.
Preferred Qualification If you have the following characteristics, it would be a plus: - Advanced degree (MS, PhD or equivalent) in a relevant scientific discipline. - Experience with US FDA interactions and familiarity with CBER expectations. - Experience with lifecycle management and post-approval CMC changes. - Prior people management experience or leading small technical teams. - Experience with tech transfer and commercialization activities. - Knowledge of GMP, validation and facility/equipment regulatory considerations.
What we offer in this role You will work on meaningful projects that progress vaccine candidates and support public health. You will join a team that values collaboration, learning and clear purpose. We welcome applicants from varied backgrounds and encourage you to apply if you meet many of the qualifications but not every one.
Working model This position is based in Belgium and follows a hybrid working model. You will be expected to work on-site regularly to collaborate with colleagues and external partners. How to apply If this role matches your skills and ambitions, we encourage you to apply.
Please share your CV and a brief note describing what you would bring to the role and why you want to join our team. We look forward to hearing from you. Polish Salary Range / Polski przedział wynagrodzenia: PLN 306,750 to PLN 511,250Italian Salary Range / Fascia retributiva in Italia: EUR 57,300 to EUR 95,500Belgium Salary Range / Fourchette salariale – Belgique: EUR 90,000 to EUR 150,000The annual gross base salary range for new hires in this position is listed above for each applicable location.
These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role.
More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role.
If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role.
Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Le salaire de base mensuel brut minimum pour les nouvelles recrues à ce poste est indiqué ci dessus pour chaque lieu applicable.
Ce salaire de base mensuel brut minimum tient compte de plusieurs facteurs, notamment les compétences, l’expérience et le niveau de formation du/de la candidat(e), ainsi que le taux du marché pour le poste. En outre, ce poste peut donner droit à un bonus annuel ainsi qu'une éligibilité pour participer à notre programme de long term incentive basé sur des actions, en fonction du niveau du rôle.
Des informations plus détaillées sur l’ensemble du package salarial seront fournies au cours du processus de recrutement. Ce poste étant ouvert à des candidat(e)s basé(e)s dans plusieurs pays, des fourchettes de salaire sont également indiquées pour certains lieux.
Les fourchettes salariales pour d'autres localisations sont mentionnées parce que certains marchés ont des lois en matière de transparence salariale qui imposent que les informations sur les salaires soient affichées dans les offres d’emploi, et que ces pays sont des lieux potentiels pour ce poste.
Si aucune fourchette salariale n’est indiquée dans l’offre d’emploi pour un lieu ou un pays spécifique, la rémunération correspondante sera discutée au cours du processus de recrutement. Veuillez noter que les salaires varient selon le pays en fonction des compétences, de l'expérience, du niveau de formation du/de la candidat(e) et du taux du marché pour le poste.
Les offres sont généralement faites dans la fourchette annoncée en fonction des compétences, de l'expérience et des qualifications du/de la candidat(e), la partie haute de la fourchette étant généralement réservée aux profils très expérimentés ou à des circonstances exceptionnelles répondant à ces critères.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements. Why GSK? Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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