Scientific Leader/Associate Director, Biologics Drug Product Development

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Dec 4, 2022

View more

Sector
Science, Pharmaceutical
Organization Type
Corporate
Jobseeker Type
Professional
Job Description

GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.

Drug Product Development (part of the wider Medicine Development and Supply organization) 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 may include protein formulation development and optimization, stability and shelf-life assessment, and drug product process development, characterization, and technology transfer activities. The role will require leadership skills including expectations to lead a matrix team involved with the transfer, validation, and commercialization of drug product manufacturing processes. The role may require management of a direct report or reports. The position may include externalization of some work packages to key partners of the Drug product development organization in both the US and the UK. The position will also require flexibility to handle non-project specific initiatives to support the department, and expectations for networking with the wider scientific community.

Specific responsibilities will be focused on:

  • Supporting 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. The position will include taking a lead role in drug product manufacturing process development, characterization, and tech transfer to GSK internal sites and/or external contractors. The position will require development of the drug product manufacturing control strategy, and authoring sections of regulatory submissions. Mentoring and developing junior staff in generating scientific protocols and reports will also be required.


  • Additional responsibilities will include development/optimizing protein formulations for commercialization, providing strategic input for stability protocols, shelf-life setting, product comparability, and specifications. Maintaining accurate, complete laboratory records/ reports with a high level of data integrity following ALCOA+ principles; embody the GSK values and expectations; facile use of electronic data & information gathering, capture, archiving and communications techniques; and, assisting in preparation and review of SOPs, and regulatory documentation, as appropriate.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • The ideal candidate will have a:

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


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Knowledge around current regulatory expectations and requirements to commercialize biopharmaceutical drug products including combination products
  • Expertise in establishing overall control strategy for Biopharm drug product
  • Proven ability to lead collaboratively in a matrix style environment
  • Authoring (or co-authoring) of publication(s) in peer-reviewed scientific journals
  • Authoring DP sections of regulatory documents (IND/IMPD, BLA/MAA/JNDA, etc.)
  • In-depth understanding of biopharmaceutical product development including formulation, stability, process development/characterization and technology transfer
  • Familiarity with areas of bioanalytical and biophysical testing, and data analysis
  • Demonstration of data integrity principles
  • Provide scientific direction and mentorship to scientists in the group on projects, study design, execution, and report writing


Why 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

#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 impact the health of 2.5 billion people around the world in the next 10 years.

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.

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.

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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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