Associate Director Drug Product Development

Site Name: USA - Pennsylvania - Upper Providence
Posted Date: May 18 2023

We are seeking an Associate Director of Drug Product Development to join our team that is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the life cycle of asset development from discovery through commercialization. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing both small molecule and BioPharm drug product/ device development and packaging. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.

Within Drug Product Development (DPD), the DPD-Steriles department focuses on developing world class patient-centric biopharmaceutical and small-molecule drug products through innovation, technology, and strategic partnering. The successful candidate for this position will focus on biopharmaceutical development, more specifically on the development of drug product and delivery systems for protein-based therapeutics and contributes to defining scientific strategy across projects/initiatives.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Embody the GSK values and expectations
• Facile use of electronic data & information gathering, capture, archiving and communications techniques; and
• Maintain accurate, complete laboratory records/ reports with a high level of data integrity following ALCOA+ principles.
• Take a lead role in drug product manufacturing process development, characterization, and tech transfer to GSK internal sites and/or external contractors.
• Provide strategic input for stability protocols, shelf-life setting, product comparability, and specifications.
• Development/optimize protein formulations for commercialization.
• Mentor and develop junior staff in generating scientific protocols and reports will also be required.
• Support the progression of the late phase portfolio including managing assets from Phase 2 through commercialization, included serving as drug product workstream lead and/or technical transfer lead in a matrix team environment.
• Assisting in preparation and review of SOPs, and regulatory documentation, as appropriate.
• Development of the drug product manufacturing control strategy, and authoring sections of regulatory submissions.

Basic Qualifications

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

PhD degree in Pharmaceutical Sciences, Biology, Chemistry, Chemical Engineering, with 7+ years of protein formulation and/or drug product development experience; or, MS degree with 10+ years of experience; or, BS degree with 15 years experience.

Preferred Qualifications

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

• In-depth understanding of biopharmaceutical product development including formulation, stability, process development/characterization and technology transfer
• Demonstration of data integrity principles
• Creative and motivated self-starter, with excellent verbal and written communication skills
• Sound and timely decision-making and problem-solving skills in high impact situations
• Proven ability to lead collaboratively in a matrix style environment.
• Provide scientific direction and mentorship to scientists in the group on projects, study design, execution, and report writing.
• Facile use of electronic data & information gathering, capture, archiving and communications techniques.
• Expertise in establishing overall control strategy for BioPharm drug product.
• Authoring DP sections of regulatory documents (IND/IMPD, BLA/MAA/JNDA, etc.)
• Knowledge around current regulatory expectations and requirements to commercialize biopharmaceutical drug products including combination products.
• Ability to work independently and across organizational and geographic boundaries as well as work effectively in team and matrix environments.
• Authoring (or co-authoring) of publication(s) in peer-reviewed scientific journals
• Familiarity with areas of bioanalytical and biophysical testing, and data analysis

Why GSK?

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more:

Our approach to R&D

#LI-GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.