Are you looking for an impactful role that leverages your technical expertise and ability to build exceptional relationships with trusted global partners to develop an increased number of transformative medicines for our patients? If so, this Associate Director of Oral Product Development role lies withina rapidly growing, empowered, innovative and agile Strategic External Development organization and could be an ideal opportunity to explore.
As a n Associate Director of Oral Product Development, you will contribute to internal and external development of the company's oral drug products.
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:
- Lead drug product development and manufacturing efforts for Oral small molecule 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 product and process development/scale-up/transfer activities at internal and external 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 clinical supply manufacturing, change control implementation and technical investigations.
- Assist project management to proactively build detailed CMC timelines with clarity to assumptions, risks, and decision points.
- Prepare and keep current written CMC development strategies in alignment with overall program objectives. Presents results and progress of CMC programs to internal and external audiences as appropriate.
- Develop and document the knowledge base needed for regulatory filings. Provide subject matter expert scientific review of CMC sections of regulatory documents.
- Flexible work schedule to accommodate program priorities and international activities as needed.
- Travel (some international)
We are looking for professionals with these required skills to achieve our goals:
- BS in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline with 12 + years of pharmaceutical industry experience in small molecule, oral drug product, or sterile liquid development and manufacturing;
- Experience with vendor management.
- Experience development and commercialization of small molecule drug products.
- Experience leading internal and external product development projects.
- Experience with Quality by Design ( QbD ) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of drug product formulation and/or manufacturing process.
- Experience working with the interrelationships between formulation, process development and drug delivery and an understanding of how preclinical, clinical, and commercial drivers affect the development pathway of drug candidates from research through life cycle management.
- Working knowledge with FDA/ICH/EMA guidelines and cGMPs , phase appropriate development strategies across IND-NDA stages and global requirements for IND and NDA submissions (or their regional equivalents)
- Experience with IND/ MAA writing and/or review
Why GSK? Uniting science, talent, and technology to get ahead of disease together
- MS or PHD in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required with 10 + years of pharmaceutical industry experience
- Experience with drug delivery strategies of challenging compounds and/or sterile drug products.
- Experience with Sterile liquid drug product
- Strong technical/analytical skills to identify and solve problems.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites.
- Strong organizational skills to maintain a high level of productivity, innovation, and setting priorities to complete assignments in a timely manner and within budget.
- Ability to exhibit high initiative, strong drive, and follow-through.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes 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 genetics science; 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 disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as 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 culture that is ambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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