Sterile Formulation Scientific Leader/Associate Director - Injectable Products

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Closing date
May 25, 2022

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Discipline
Physical Sciences, Chemistry
Job Type
President/CEO/Director/VP
Organization Type
Pharma
Site Name: USA - Pennsylvania - Upper Providence Posted Date: May 6 2022 Member of a team responsible for enabling the progression of NCE's from candidate selection to product commercialization. Leading drug product development matrix teams supporting product development. Progress drug product design & development aspects of projects, utilizing experience and expertise as part of a Product Development &Supply technical matrix team and wider matrix teams. Exercise professional judgment to determine the most appropriate course of action for a project. Leads or contributes to Pharmaceutical Development strategies. Develop phase appropriate formulations to support clinical studies and ultimately commercialization. Develop and optimize processes for the manufacture of drug products and participate in manufacturing of clinical supplies. Design and execute DOE, scale up studies, and participate in technology transfer. Prepare development reports and participate in preparing regulatory documents. Propose and deliver innovative approaches to achieve project goals. Provide correct interpretation of results and perform complex data management and analysis. Basic Qualification: PhD in Pharmaceutics, Chemical Engineering, or other related fields with a minimum of 5 yrs. of industrial experience in pharmaceutical development. Preferred Qualifications: Experience in formulation and process development of small molecules, particularly novel complex injectable products, e.g. long acting injectables, liposomes, etc. Experience in developing phase appropriate formulations and manufacturing processes for small molecules. Experience in authoring drug product modules of new drug applications and marketing authorization applications is preferred. Good understanding of physico-chemical properties and biopharmaceutics is desired. Expertise in sterilization techniques is preferred. Experience in working within a product development matrix team. Experience in leading a product development matrix team is preferred. Demonstrates strong networking skills through interactions across departments, divisions, and disciplines Familiar with cGMP and regulatory requirements for manufacturing operations and documentation. Good oral and written communication skills. Why GSK At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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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