The Investigator, Chemical Development will be responsible for the development, optimization, implementation, and management of robust, cost effective, and safe processes for the manufacture of small molecules including Oligonucleotide Active Pharmaceutical Ingredients (APIs) and/or Antibody Drug Conjugates (ADCs).

The incumbent will be responsible for the technical development, support, validation and commercialization of drug substances using an external and internal network of providers. This position is integral to the advancement of GSK's growing portfolio of drug candidates and technology programs.

The scope of the role encompasses a wide breadth of lifecycle, ranging from early stage development, late stage development, process validation to commercial manufacturing. S/he will be expected to manage these activities using an outsourcing model and to work within a cross-functional team environment of external service providers and internal team members to help define project scope and plan, and ensure successful delivery with regards to process development, technical troubleshooting, quality, compliance, milestone timelines and project budget.

The successful candidate will report directly to the Director, Chemical Development.

Travel - 15% both domestically and internationally.

Job Responsibilities

• Provide support of Active Pharmaceutical Ingredients (API) development programs.
• Collaborate and coordinate in cross-functional teams, both internally and at CROs (contract research organizations) to develop robust, scalable, cost effective and safe chemical processes.
• Responsible for timely deliveries of drug substance to support IND/IMPD enabling toxicology studies as well as manufacture of phase-appropriate cGMP API.

• Work closely with external partners for the evaluation, technology transfer, scale-up and implementation of new processes for drug substance manufacture, including support of validation activities when progressing to late stage.
• Recommends the development of economical, state-of-the-art techniques to synthesize, purify, isolate and characterize drug substance by keeping up to date with the scientific literature, regulatory guidelines and industry advances
• Troubleshoot new and existing product or process issues related to yield, quality and throughput, utilizing structured problem-solving techniques and quality assurance mechanisms when appropriate.
• Ensure the work conducted by external partners and the group is performed in accordance with GSK and external regulatory and quality standards in the markets of interest and is also conducted in accordance with GSK and local EH&S standards
• Design, manage, and analyze data from experiments to screen, optimize, and scale chromatographic and synthetic chemistry processes.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• PhD in synthetic organic chemistry, or a related scientific/engineering discipline OR a BS/MS and 3+ years of industry experience
• Experience in the areas of process development, process characterization, process validation and product life cycle management
• Experience working in a virtual CMC development/commercialization environment and collaborating with external partners (CDMOs/CROs)
• Experience with control strategy development by either process characterization or design space studies using DoE or modelling tools.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Extensive knowledge of oligonucleotide chemistry including potential routes of impurity formation and the ability to develop processes to oligonucleotide drug targets
• Practical experience of laboratory and /or plant scale oligonucleotide synthesis, purification and isolation
• Fundamental understanding of the role of ADCs (Antibody Drug Conjugates) in the biopharmaceutical industry, with knowledge of the technical challenges of development and manufacture
• Desire to acquire new knowledge in chemistry and biopharmaceutical science
• Strong collaboration and communication skills; ability to build and maintain good working relationships with internal and external stakeholders.
• Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
• Experience with control strategy development by either process characterization or design space studies using DoE or modelling tools.
• Experience in collaborations with medicinal chemistry, analytical, biology, toxicology, clinical pharmacology, Quality Assurance, Regulatory CMC and CMC development departments.
• Experience in preparation of CMC documents in support of global regulatory filings across development stages (e.g. IND to NDA and IMPD to MMA).

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Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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