Scientific Leader
Posted on: 5 Oct 2021
King of Prussia, PA
Job Description
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Manage and provide development opportunities for of a small team of junior scientists
Represent the department on project teams
Lead and participate in ongoing platform development initiatives including the development of perfusion/continuous upstream processes and technology development efforts
Participate in strategic planning for the direction of the department and the Biopharm CMC organization
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
PhD or equivalent experience in Chemical/Biochemical Engineering or related Biological Science with 7+ years of industrial experience in the Biotech industry
Experience in developing cell culture processes for biopharmaceutical production with exposure to cGMP requirements
Experience in technology transfer to manufacturing sites
Hands-on experience with process scale-up/process characterization
Experience in authoring CMC sections for regulatory filings
4+ years of supervisory experience leading technical teams
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Familiarity with current QbD approaches and Control Strategy Development
Very good understanding of small-scale model qualification and challenges faced during scale-up
Good communication skills and ability to work in matrix teams
Authoring and review of BLA & MAA drug substance modules
Detailed knowledge of Process Validation requirements
Working knowledge of PAT tools such as Raman, capacitance probes, and in-line UV measurements
Demonstrated mastery of handling large sets of data, including statistical analysis using software packages such as JMP/SIMCA/etc.
Detailed knowledge of multivariate analysis and DoE approaches
A thorough knowledge of the workings of large scale bio-reactors, especially aspects concerning mass transfer and mixing times
GSK group of companies
Philadelphia, PA
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies.
Our values and expectations are at the heart of everything we do and help define our culture - so that together we can deliver extraordinary things for our patients and consumers and make GSK a brilliant place to work.
Our values are Patient Focus, Transparency, Respect, Integrity.
Our expectations are Courage, Accountability, Development, Teamwork.
Across the US, we employ more than 15,000 people - from our Vaccines R&D headquarters in Maryland, to our R&D Hub in Pennsylvania, and from one of our nearly 10 manufacturing sites across America, our employees and our values are at the heart of everything we do.
What we do
We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.
Our Pharmaceuticals business has a broad portfolio of innovative and established medicines with commercial leadership in respiratory and HIV. Our R&D approach focuses on science related to the immune system, use of genetics and advanced technologies.
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IndustryBiopharmaceuticals
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No. of Employees15,000+
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Website
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Jobs Posted237
