Senior Manager, Chemical Development
Site Name: USA - Massachusetts - Waltham Posted Date: Jul 20 2021 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. 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 of Active Pharmaceutical Ingredients (API) development programs. The candidate will identify opportunities and activities that can enable the scale up of drug candidates for pre-clinical and clinical studies as well as supporting validation activities when progressing to late stage. Collaborate and coordinates 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 to support clinical studies. To develop and optimize safe and scalable chemical processes for the manufacturing of drug substance. 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. Construct and manage experiments to screen, optimize, and scale chromatographic and synthetic chemistry processes. 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 Preparation of technology transfer packages to support technical transfer activities between GSK and supplier, or between suppliers and support of technical audits. Why you? 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 biotech or pharma industry, or BS/MS with 8+ experience is required. Experience in the areas of process development, process characterization, process validation and product life cycle management Experience working in a virtual CMC development with global providers. Experience in collaborations with medicinal chemistry, analytical, biology, toxicology, clinical pharmacology, Quality Assurance, Regulatory CMC and CMC development departments. Experience determining appropriate resources for resolution of problems, to have strong organizational and planning skills and work independently. Ability to travel ~ 30% both domestically and internationally. Preferred Qualifications: If you have the following characteristics, it would be a plus: 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. 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 preparation of CMC documents in support of global regulatory filings across development stages (e.g. IND to NDA and IMPD to MMA). Thorough understanding of oligonucleotide chemistry, including phosphoramidite based synthesis methods, deprotection, purification and isolation methods. Ability to apply organic chemistry to designing and developing new synthetic routes. *LI-GSK GSKBiopharm_Development Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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.