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Senior Manager, Oral Product Development

Waltham, Massachusetts
Closing date
Sep 21, 2021

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We are looking for professionals with these required skills to achieve our goals: Demonstrated knowledge, experience, and a successful track record in formulation development of small molecule oral dosage and biopharm sterile drug products is required. Experience with Quality by Design (QbD) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of drug product formulation and/or manufacturing process is required. Experience with formulation, drug delivery strategies of challenging compounds and/ or lyophilized products is preferred. Demonstrated capability to lead multiple external product development projects is preferred. Working knowledge of the interrelationships between formulation, process development and drug delivery and an understanding of how preclinical, clinical, and commercial drivers affect the development pathway of drug candidates from research through life cycle management is highly preferred. CMO manufacturing experience is highly preferred. Working knowledge of FDA/ICH/EMA guidelines and cGMPs, phase appropriate development strategies across IND-NDA/BLA stages and global requirements for IND, NDA, and BLA submissions (or their regional equivalents) is highly preferred. Experience with IND/NDA/BLA/MAA writing and/or review is highly preferred. Strong technical/analytical skills to identify and solve problems are required. Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites are required. Strong organizational skills in order to maintain a high level of productivity, innovation, and setting priorities in order to complete assignments in a timely manner and within budget. Exhibits high initiative, strong drive and follow-through. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Previous pharmaceutical industry experience in oral dosage and/or biologics sterile product development 8-10 years of experience with BS/MS degree n Pharmaceutical Sciences, Chemistry, Biochemistry, Engineering, Materials Science or related scientific discipline required. or 5 years of experience with PhD degree for Senior Manager level role Extensive experience with vendor management. Travel (some international) will be required. Preferred Qualifications: 10+ years of experience with BS/MS degree or 8+ years of experience with PhD degree for Associate Director role Requires a flexible work schedule to accommodate program priorities and international activities. If you have the following characteristics, it would be a plus: Ability to implement a six-month planning horizon Understanding of actives, raw materials and their function and how they are brought together to form a stable, functioning product from prototype evaluation to commercial launch Demonstrate communication skills with external key opinion leaders/experts in specific therapeutic areas or scientific disciplines Knowledge of related disciplines and how research in formulation should be designed to take account of related disciplines Demonstrate good judgment and effective decision making in applying expertise to move multiple scientific or technical projects forward 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, rigor 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 We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us! Click to know more about GSK Biopharm. #GSKBiopharm_Development 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.
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