The Manager for Chemical Development (Engineering) will be responsible for the external development, scale-up, technology transfer and management of robust, cost effective, and safe processes for the manufacture of small molecule and antibody-drug conjugates (ADCs) drug substance.

The incumbent will be responsible for the technical development, clinical production support abd validation of drug substances using an external 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 and commercialization. In this role you will be expected to manage these activities using an outsourcing model. You will work in a cross-functional team environment to help define project scope plans, and ensure successful delivery with regards to process development, technical troubleshooting, quality, compliance, project timelines and budget. You will be responsible for building/maintaining strong working relationships with external partners.

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

Ability to travel ~ 15% both domestically and internationally.

Job Responsibilities:

• Provide process engineering support and scale up of small molecule drug substance and antibody-drug conjugate development programs.
• Collaborate and coordinate in cross-functional teams, both internally and with CDMOs (contract development and manufacturing organizations) to develop robust, scalable, cost effective and safe processes.
• Responsible for timely deliveries 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 and/or equipment.
• 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.
• Develop and contribute to assessments for identifying, managing, and reducing product / process risk utilizing a variety of techniques including Technical Risk Assessments, Failure modes and effects analyses (FMEAs), and Hazard and Operability Studies (HAZOP).
• Create, review and/or approve technical documents including batch records, engineering / development reports, protocols and risk assessments.
• Construct, manage and analyze data from experiments to screen, optimize, and scale synthetic chemical processes.

Basic Qualifications:

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

• BS/MS in chemical engineering or related field science with 3+ years of experience in pharmaceutical research and development or biotechnology.
• Experience with ADC conjugation/ bio-conjugation
• Experience working in a virtual-CMC development/commercialization environment, collaborating with external partners.
• Experience in the development and/or manufacturing experience of highly potent active pharmaceutical ingredients (HPAPIs)

Preferred Qualifications:

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

• Experience with technology transfers, technical risk assessments, and product control strategies.
• Experience with design of experiments (DoE) and modelling tools.
• Experience with purification unit operations such ultrafiltration/diafiltration (UF/DF) and chromatography
• Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration in a multi-disciplinary business and science team environment is essential.

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