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Manager Chemical Development
Location:
Collegeville, PA
Description:
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 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 ADC conjugation/ bio-conjugation 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. #LI-GSK#mdsoligoPlease 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.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-XXXX (US Toll Free) or +1 801 567 XXXX (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.PDN-9baf4662-81cc-4612-9746-016fe812d0b1
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More About this Listing: Manager Chemical Development
Manager Chemical Development is a Executive Manager Job at GSK located in Collegeville PA. Find other listings like Manager Chemical Development by searching Oodle for Executive Manager Jobs.
Manager Chemical Development is a Executive Manager Job at GSK located in Collegeville PA. Find other listings like Manager Chemical Development by searching Oodle for Executive Manager Jobs.