Current jobs related to Associate Director/Scientific Leader – Sterile Drug Product Development - King of Prussia - GSK
-
Global Product Leader
6 days ago
King Of Prussia, United States CSL Behring Full timeThe Opportunity:As the Global Product Lead (GPL), you will be a senior, cross-functional strategic leader in the CSL organization, reporting to the R&D Therapeutic Area Co-Lead. You will be accountable for all product strategy and delivery in your portfolio and, in that capacity, to the respective Therapeutic Area Leadership Team (TALT) and TA Co-Leads. You...
-
Global Product Leader
3 weeks ago
King of Prussia, United States CSL Behring Full timeThe Opportunity:As the Global Product Lead (GPL), you will be a senior, cross-functional strategic leader in the CSL organization, reporting to the R&D Therapeutic Area Co-Lead. You will be accountable for all product strategy and delivery in your portfolio and, in that capacity, to the respective Therapeutic Area Leadership Team (TALT) and TA Co-Leads. You...
-
Global Product Leader
2 weeks ago
King of Prussia, United States CSL Behring Full timeThe Opportunity:As the Global Product Lead (GPL), you will be a senior, cross-functional strategic leader in the CSL organization, reporting to the R&D Therapeutic Area Co-Lead. You will be accountable for all product strategy and delivery in your portfolio and, in that capacity, to the respective Therapeutic Area Leadership Team (TALT) and TA Co-Leads. You...
-
Global Product Leader
7 days ago
King of Prussia, United States CSL Behring Full timeThe Opportunity:As the Global Product Lead (GPL), you will be a senior, cross-functional strategic leader in the CSL organization, reporting to the R&D Therapeutic Area Co-Lead. You will be accountable for all product strategy and delivery in your portfolio and, in that capacity, to the respective Therapeutic Area Leadership Team (TALT) and TA Co-Leads. You...
-
Clinical Science Director Temporary
2 weeks ago
King of Prussia, United States Joulé Full timeJob Title - Temporary Clinical Science Director Job Location - King of Prussia, Pennsylvania, 19406 Type: Contract SUMMARY/JOB PURPOSE: In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical...
-
Clinical Science Director Temporary
2 weeks ago
King of Prussia, United States Joulé Full timeJob Title - Temporary Clinical Science DirectorNot sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements. Job Location - King of Prussia, Pennsylvania, 19406 Type: Contract SUMMARY/JOB PURPOSE: In collaboration with clinical and project teams of the company, the...
-
Clinical Director
2 weeks ago
King of Prussia, United States Planet Pharma Full timeSUMMARY/JOB PURPOSE:In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical development related documents including study synopses and protocols. Summarizes study results for preparation of documents and...
-
Clinical Director
2 weeks ago
King of Prussia, United States Planet Pharma Full timeSUMMARY/JOB PURPOSE:In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical development related documents including study synopses and protocols. Summarizes study results for preparation of documents and...
-
Clinical Science Director
1 week ago
King of Prussia, United States TechData Service Company LLC Full timeJob DescriptionJob DescriptionClinical Science Director (Contract) – Remote - BB158BB158King of Prussia, PA (Remote6+ MonthsSUMMARY/JOB PURPOSE: In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical...
-
Clinical Science Director
4 days ago
King of Prussia, United States TechData Service Company LLC Full timeJob DescriptionJob DescriptionClinical Science Director (Contract) – Remote - BB158BB158King of Prussia, PA (Remote6+ MonthsSUMMARY/JOB PURPOSE: In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical...
-
Associate Director, HEOR
18 hours ago
King of Prussia, United States CSL Full timeThe Associate Director of Health Economics and Outcomes Research (HEOR) will be leading the development and execution of HEOR strategies for CSL Behring or Vifor assets primarily within a specific disease area. This role focuses on leading the plan, execution and dissemination of the payer evidence generation to maximize the asset's value throughout its life...
-
Planet Pharma | Clinical Director
7 days ago
king of prussia, United States Planet Pharma Full timeSUMMARY/JOB PURPOSE:In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical development related documents including study synopses and protocols. Summarizes study results for preparation of documents and...
-
Global Product Leader
2 weeks ago
King of Prussia, PA, United States CSL Behring Full timeThe Opportunity:As the Global Product Lead (GPL), you will be a senior, cross-functional strategic leader in the CSL organization, reporting to the R&D Therapeutic Area Co-Lead. You will be accountable for all product strategy and delivery in your portfolio and, in that capacity, to the respective Therapeutic Area Leadership Team (TALT) and TA Co-Leads. You...
-
Executive Director, Medical Specialty
3 weeks ago
King of Prussia, United States CSL Full timeAs a true expert in the responsible TA, the Executive Director, will lead the development and execution of Medical Affairs strategies and tactics in support of the US market to demonstrate the value of CSL Behring's products in the respective Therapeutic Area (TA). She/He will provide the necessary up to date understanding of the US medical practice to...
-
Business Development
3 months ago
King of Prussia, United States CSL Behring Full timeSummary of RoleReporting to the Senior Director Global Business Development and Licensing, this role is responsible, on a global basis, for business development and licensing activities for the CSL product portfolio.This includes leading cross-functional, global and regional diligence and deal teams, and negotiating license and distribution agreements...
-
Clinical Development Team Leader
6 days ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeWelcome to CSL BehringOur MissionWe are a global biotechnology leader driven by a promise to save and improve lives. Our mission is to deliver medicines that improve the lives of people worldwide who live with rare and serious medical conditions.At CSL Behring, we believe in the importance of innovation and collaboration in addressing the complex challenges...
-
Clinical Science Director
5 days ago
King of Prussia, United States Meet Full timeSummary:Our client is seeking a Clinical Science Director to collaborate with clinical and project teams to design, plan, and develop oncology clinical studies. This role involves authoring clinical development documents, summarizing study results, supporting project teams with scientific insights, and providing progress updates on clinical studies.Essential...
-
Director, QC
2 weeks ago
King of Prussia, United States EPM Scientific Full timeA global biopharmaceutical organization is hiring for a global leadership role that works cross functionally with R&D, Quality Control, and Regulatory. If you're an innovative leader that's looking for a strategic focused position that impacts an organization globally, then please apply in! Job Title: Director of Reference Materials and ReagentsOverview:...
-
Clinical Development Manager
3 days ago
King of Prussia, Pennsylvania, United States Planet Pharma Full timeAbout the RoleThe Senior Clinical Scientist will play a critical part in the development of clinical oncology studies at Planet Pharma. This individual will collaborate with clinical and project teams to design, plan, and execute clinical studies, ensuring compliance with project plans, federal regulations, GCP, and good medical practice. A strong background...
-
Business Development
2 weeks ago
King of Prussia, United States CSL Behring Full timeBusiness Development & Licensing Director, Cardio Renal, CSL Vifor at CSL Behring summary: The Business Development & Licensing Director for Cardio Renal at CSL Vifor is responsible for overseeing global business development and licensing activities, with a focus on the company's cardiorenal product portfolio. This role includes leading cross-functional...
Associate Director/Scientific Leader – Sterile Drug Product Development
1 week ago
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Dec 19 2024
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.
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, specifically on the development of drug product and delivery systems for protein-based therapeutics and contribute 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.
Specific responsibilities will be focused on:
- Supporting the progression of the late phase portfolio including managing assets from Phase 2 through commercialization, 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.
- 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; embodying the GSK values and expectations; assisting in preparation and review of SOPs, and regulatory documentation, as appropriate.
Basic Qualifications:
- PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline with 7+ years of protein formulation and drug delivery development experience.
- or MS degree with 10+ years of protein formulation and drug delivery development experience.
- or BS degree with 15+ years of protein formulation and drug delivery development experience.
- Experience in authoring technical reports and regulatory documentation (IND/IMPD, BLA/MAA, etc.)
Preferred Qualifications:
- Creative and motivated self-starter, with excellent verbal and written communication skills, demonstrated ability to work independently and across organizational and geographic boundaries as well as work effectively in team and matrix environments.
- Ability to demonstrate sound and timely decision-making and problem-solving skills in high impact situations.
- Knowledge around current regulatory expectations and requirements to commercialize biopharmaceutical drug products including combination products.
- Expertise in establishing overall strategy for late phase Biopharm drug products and drug device combination products.
- Proven ability to lead collaboratively in a matrix environment.
- Authoring (or co-authoring) of publication(s) in peer-reviewed scientific journals.
- 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.
- Experience with technical risk assessments (FMEA) and control strategy development.
- Good knowledge of QbD as presented in regulatory dossiers.
- Experience conducting root cause analyses and investigations.
#LI-GSK
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. Our success depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
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.
#J-18808-Ljbffr