The Sr. Manager is expected to manage a group to design and execute scientific studies in support of technical development programs as they progress from discovery and early development into Phase I/ II, Phase III, technology transfer and process performance qualification at the intended commercial site, including post-authorization line extensions and/or product & process optimization.
*This role will be based in Rockville, MD. Relocation will be provided if applicable.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Why you?Basic Qualifications:
- Manage/organize a group to designs and leads specific development workstreams autonomously, in line with business priorities, following the Quality by Design framework.
- Resource adequately projects and programs with employees with appropriate strategy via insourcing or outsourcing
- Accountable for all transversal aspects such as Process Control and Data Archiving, DoE plan and Mathematical Modelling.
- Lead external collaborations.
- Accountable for disruptive innovation in collaboration with internal experts and/or in partnership with external companies and institutions.
- Identify risks on developability, process feasibility or manufacturability, timing and resources constraints and seek a remediation plan for identified risks and escalate any technical issues to the Technical Development Team and other relevant bodies.
- Lead PhI/II and PhIII process transfer to Pilot Plant to ensure efficient production of PhI/II or PhIII clinical grade material. Bring scientific expertise and give technical support to Pilot Plant managers during GMP campaigns.
- Ensure process knowledge continuity, through Core Team, from early to late development, PhIII clinical lots production and up to first commercial lots manufacture in GIO.
- Develop an end-to-end vision of the process development in order to fulfil all the requirements in alignment with manufacturing constraints.
- Develop people in order to integrate early and late development activities and promote an efficient and innovative working environment.
- Harmonize technology, development approaches, documentation, process history file, between early and late development.
- Perform technology and patent watch for maintaining innovation and up-to-date technology for developing new vaccine projects.
- Prepare and presents scientific data within Technical R&D including Technical Development Team and may represent GSK externally (conferences, etc).
- Communicate effectively within TRD and with external stakeholders and is able to defend scientific and technical decisions at the appropriate boards.
- Operate at the interfaces with Preclinical R&D for early stage programs or with GIO/MSAT for late stage and post-authorization programs
- Benchmark specific technologies in own functional area to bring technology to state of the art.
- Contribute to and drive strategy and technical development planning and accountability in the execution thereof.
- Ensure execution of the function's risk assessment and escalate at relevant bodies. Development of mitigation plans.
- Act as a voice and ambassador of its department at various governance bodies / meetings.
- Lead and implement the respect of the GxP / EHS / QA rules application.
We are looking for professionals with these required skills to achieve our goals:
- PhD degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field with 3+ years of post-doc and/or job-related experience, or MS with 6+ years of experience, or BS with 9+ years of experience
- Experience with biopharmaceutics and/or vaccine early and late-stage process development required
- Experience in processes and unit operations used to manufacture biopharmaceuticals and/or vaccines
- Experience with pharmaceutical lyophilization
- Experience in the preparation and preservation of liposomes and/or lipid-based delivery vehicles
- Experience in the development of protein antigen-based vaccines
- Experience in sterile drug product manufacturing
- Experience in drug product formulations and associated technologies
If you have the following characteristics, it would be a plus:
- Ability to effectively manage a team of dedicated scientists
- Ability to work with cross-functional teams and in matrix environments
- Competency to influence scientific and technical vision and strategy
- Must be able to work with individuals having different cultures/values
- Experience in technology transfer in manufacturing
- Excellent presentation, interpersonal and communication skills
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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