Are you a scientist in sterile drug product development eager to lead the development of life-changing drug products? Are you eager to unite science, talent, and technology to get ahead of disease together? This may be the right opportunity for you! Drug Product Development (DPD), is part of the wider R&D Medicine Development and Supply organization, and is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competit... more details
Are you a scientist in sterile drug product development eager to lead the development of life-changing drug products? Are you eager to unite science, talent, and technology to get ahead of disease together? This may be the right opportunity for you!
Drug Product Development (DPD), is part of the wider R&D Medicine Development and Supply organization, and is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full 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 large molecule (biopharma) drug product development. We also pioneer innovative technologies and employ data science 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 drug product development for protein (e.g., mAbs, bispecific mAbs, ADCs) and peptide-based therapeutics. This role will include serving as a drug product development lead, primarily for assets being developed for Clinical Phases 2 and 3, and commercialization. Associated activities may include protein formulation and development stability assessment, in-use compatibility/stability assessments to support product administration, drug product process development, characterization, and technical transfer activities.
Role responsibilities may include matrix leadership and working with other departments to progress drug product development. Responsibilities may also include laboratory experimentation, with application of biophysical techniques and development (non-GMP) stability studies to optimize protein formulation. The position will also require authoring of technical and regulatory documents, maintaining accurate, complete electronic laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques.
Because the department encompasses both small molecule and large molecule (biopharma) development, there may also be opportunities to contribute to development of small molecule drug products (e.g., chemical entities and oligonucleotides).
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- PhD degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biology, Bioengineering, Biomedical engineering, or Chemical Engineering with 0+ years of protein formulation and/or process development or, MS degree with 5+ years of industry experience; or, BS degree with 10+ years of industry experience.
- Experience in authoring technical documents
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Experience or ability to interpret results from multiple bioanalytical techniques for product characterization and product stability evaluation.
- Experience with both conventional and alternative biopharmaceutical protein formulation, and drug product development and stability evaluation, including the application of DOE and other statistically based experimental design/interpretation approaches.
- Experience with protein drug product manufacturing processes and development (e.g., solution in vial/PFS, or lyophilization); container/closure assessment & selection, drug delivery (e.g., combination product, device & administration kit) feasibility and compatibility evaluation.
- Experience with biophysical techniques for product characterization and stability evaluation is valuable, e.g., DSC, DSF (experience with Uncle or Prometheus Panta), particles size evaluation (MFI, FlowCam), light scattering, etc.
- Experience in authoring regulatory documentation (IND/IMPD, BLA/MAA, etc.); contributing to, and critical review of successful regulatory submissions; with particular emphasis on late clinical phase submissions, and response to regulatory questions.
- Experience in drug product manufacturing technology transfer to commercial and/or scale-up of clinical drug product manufacturing capabilities.
- Experience working with Biopharm combination products.
- Creative and motivated self-starter, with excellent verbal and written communication skills, demonstrated ability to work independently and ability to work effectively in team and matrix environments.
- Demonstrated ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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.
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.
