Senior Manager, Chemical Development

Site Name: USA - Pennsylvania

• Upper Providence, USA - Massachusetts

• Waltham

Posted Date: Jul 1 2024

Are you looking to expand your expertise with scientific technology in a global environment that allows you to keep pace with the speed of change? At GSK, we are transforming how new scientific technologies are used to improve patient's lives.

Job Description:

The Senior Manager, 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 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.

Job Responsibilities:

• Provide support for Active Pharmaceutical Ingredient (API) development programs.

• Collaborate and coordinate in cross-functional teams, both internally and at CDMOs (contract development and manufacturing 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 drug substance.

• 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.

• Recommend 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 with 5+ years of experience in pharmaceutical research and development in the biotechnology or pharmaceutical industry OR a BS/MS and 8+ 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)

• Ability to travel ~ 15% both domestically and internationally.

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).

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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