Investigator/Principal Investigator - Collegeville, United States - GlaxoSmithKline

GlaxoSmithKline Collegeville, United States

1 week ago

Description

Site Name:
USA - Pennsylvania - Upper Providence

Posted Date:
Mar

If you are looking for an exciting opportunity to make a difference in the lives of patients by applying integrated biopharmaceutics / predict first mechanistic modeling to support patient focused product development to help people do more, feel better and live longer, this might just be the role for you.

We are looking for an experienced

Investigator/Principal

Investigator, Biopharmaceutics to join the US Biopharmaceutics group within Drug Product Development.

In this role, you will interact with project teams and support the design of all new drug products (including oral, long-acting injectables, implants and biologics) developed within GSKs Pharmaceutical portfolio.

The successful candidate will utilize his/her experience in

biopharmaceutics/modeling,

and use biopharmaceutics knowledge created using integrated in-vivo, in-vitro and in-silico (physiologically based pharmacokinetic/ biopharmaceutics modelling) tools to design and develop the most suitable drug product that is fit for the patient and meets the development timelines.

Working in a dynamic, multidisciplinary environment, the candidate will be part of a team developing mechanistic models to predict in-vivo performance (pharmacokinetics) of sterile drug products (e.g., long-acting injectables, biologics).

This role will provide YOU the opportunity to lead key activities to progress YOUR career.

These responsibilities include some of the following:

Applying biopharmaceutics knowledge across projects to support integrated product design, drug delivery and targeting, innovative manufacturing processes, and smart bioavailability and bioequivalence studies, where applicable.

Developing projects/platform specific biopharmaceutics knowledge (integrated in-vivo, in-vitro, and in-silico understanding) to support the design and development of exceptional patient focused drug products (e.g., oral, long-acting injectables, implants and biologics).

Collaborating with partners across MDS and IVIVT to build mechanistic understanding of

absorption/biopharmaceutics

(through use of PBPK modeling, e.g., Gastroplus, Simcyp) and applying this fundamental understanding around product performance, biology, and PK to design the best value-added platforms and products.

Developing in-silico (digital) mechanistic models to enable science-based predictions of in-vivo performance to support sterile drug product design (e.g., long-acting injectables, biologics).

Using engineering, chemical, biological and materials science knowledge to postulate mechanisms for

physicochemical/biological

processes and developing/modifying existing mathematical models to describe those mechanisms.
Developing plans for in-vitro biorelevant measurements (e.g.,

solubility/dissolution,

IDR, permeability, transfer models for oral; in-vitro release methods for long-acting injectables and implants; SCISSOR model for subcutaneous modality) across projects and collaborating with partners (e.g., Materials Science, Analytical Development) to generate input data for modelling in-vivo product performance.

Working with team members in Drug Product Development, Drug Substance Development, Process Engineering and Analytics and Analytical Development groups to support development of clinically relevant control strategies (e.g., applying physiologically based biopharmaceutics modeling) across projects for global filings.

Providing biopharmaceutics focused technical support as needed to established commercial projects when such support is endorsed and prioritized by CMC Board.

Designing and executing modeling and/or experimental studies that influence project direction in line with QbD approaches.
Proactively engaging and collaborating with cross-functional scientists to solve problems. Demonstrating networking and influencing skills through interactions across departments and divisions.

Additional responsibilities include:
Preparing oral or written summaries of results with interpretation for project work. Writing specific technical sections of internal and external reports. Presenting effectively to internal GSK forums, governance reviews and external meetings.
Being responsible for sharing relevant scientific information from internal and external meetings with appropriate colleagues.
Demonstrating timely and reliable recording of data/results in suitable systems in accordance with company policy and legal requirements. Performing data management and data stewardship to ensure high quality and traceable work.
Collaborating with project teams to undertake formal risk assessments, root cause analyses and

investigations.
Why you?

Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
PhD in Pharmaceutics, Chemical Engineering, or related science fields .
Masters in Pharmaceutics, Chemical Engineering, or related science degree with 5+ years of experience .
Experience in

biopharmaceutics/drug

absorption, related tools (in-vivo, in-vitro, in-silico) and product design and development.

Experience in mechanistic PBPK modelling (e.g., Gastroplus, Simcyp), in-silico platforms (e.g., MATLAB, SimBiology, Python) and application to product design across dosage forms (e.g., oral, long-acting injectable, implants and biologics).

Experience in mechanism-based mathematical modeling techniques, and using complex, system level models of biological systems.

Experience in in-vitro biorelevant measurements for oral biopharmaceutics (e.g., solubility/ dissolution, IDR, transfer models, TIM-1), in-vitro release methods for long-acting injectables and implants, SCISSOR model for subcutaneous modality.

Preferred Qualifications:
If you have the following characteristics, it would be a plus:
General knowledge of preclinical and clinical development disciplines including DMPK, Safety, Clinical Pharmacology, etc. and integration of

biopharmaceutics/modeling

with formulation design across dosage forms.
Integrated understanding of the

pharmacokinetics/performance

of long-acting injectables, biologics (e.g., monoclonal antibodies), and predictive models (in-vitro, in-silico).
Demonstrated experience in understanding

biopharmaceutics/in-vivo

performance across dosage forms including oral, long acting injectables, implants and/or subcutaneous biologic products.
Experience in identifying, developing, and applying innovative solutions to scientific and technological problems faced in systems modeling.

Excellent written and oral communication skills and the ability to interact effectively with scientists in other disciplines with a positive and collaborative attitude.

Demonstrated collaborative behaviors working in a matrix environment and working across

functions/disciplines.
Understanding of late-stage product development. Understanding of regulatory requirements for change management for a global file.
Demonstrated experience in formulation design across dosage forms.
Demonstrated effective interpersonal, communications and negotiation skills. Logical and independent thinking.
Managing and delivering execution across multiple disciplines and projects.
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

t o learn more about the comprehensive benefits program GSK offers US employees.
Why Us?

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 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, its 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.

Were 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 US Toll Free) or 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 GSKs compliance to all federal and state US Transparency requirements.

For more information, please visit GSKs Transparency Reporting

For the Record

site.

#J-18808-Ljbffr

Investigator/Principal Investigator

1 week ago

GlaxoSmithKline Collegeville, United States

Site Name: USA - Pennsylvania - Upper Providence · Posted Date: Mar · If you are looking for an exciting opportunity to make a difference in the lives of patients by applying integrated biopharmaceutics / "predict first" mechanistic modeling to support patient focused product de ...
Investigator/Principal Investigator

1 week ago

GlaxoSmithKline Collegeville, United States

Site Name: · USA - Pennsylvania - Upper Providence · Posted Date: · Mar · If you are looking for an exciting opportunity to make a difference in the lives of patients by applying integrated biopharmaceutics / "predict first" mechanistic modeling to support patient focused prod ...
Investigator/Principal Investigator

3 weeks ago

Blackwomenintech Collegeville, United States

If you are looking for an exciting opportunity to make a difference in the lives of patients by applying integrated biopharmaceutics / predict first mechanistic modeling to support patient focused product development to help people do more, feel better and live longer, this might ...
Investigator/Principal Investigator

3 weeks ago

Blackwomenintech Collegeville, United States

If you are looking for an exciting opportunity to make a difference in the lives of patients by applying integrated biopharmaceutics / "predict first" mechanistic modeling to support patient focused product development to help people do more, feel better and live longer, this mig ...
Investigator/Principal Investigator

1 week ago

GlaxoSmithKline Collegeville, United States Full time

Site Name: USA - Pennsylvania - Upper Providence · Posted Date: Jun 3 2024 · If you are looking for an exciting opportunity to make a difference in the lives of patients by applying integrated biopharmaceutics / "predict first" mechanistic modeling to support patient focused prod ...
Investigator

2 weeks ago

GSK LLP Collegeville, United States

Site Name: Upper Merion, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: May Preferred Site Locations: Upper Merion, Stevenage, Upper Providence. 2-3 days on-site per week is required.Are you energized by a highly collaborative scientific role in ...
Investigator

5 days ago

GlaxoSmithKline Collegeville, United States

Site Name: · USA - Pennsylvania - Upper Providence · Posted Date: · May · As an Investigator, within Emerging Drug Delivery Platforms you will be responsible for identifying, evaluating, and supporting the implementation of the drug delivery capabilities needed by GSK to suppo ...
Principal Investigator

2 days ago

DM Clinical Research Philadelphia, United States

Job Description · Job DescriptionPrincipal Investigator (MD/DO) · The Principal Investigator will conduct all clinical trials (studies) according to ICH, GCP, local regulations, study protocols, and company processes. · Responsibilities · Ensures the medical well-being and safety ...
Principal Investigator

1 week ago

LanceSoft Philadelphia, United States

Investigation Initiation/ Deviation Management/ Manufacturing Investigations/ Process Improvement.Vaccine Manufacturing/ Sterile Processing/ Experience authoring.Identify root cause and propose effective corrective and preventative actions (CAPAs).Conducts and designs experimenta ...
Principal Scientist/investigator

2 weeks ago

GSK Collegeville, United States

**Site Name**: USA - Pennsylvania - Upper Providence · **Posted Date**: Jun 3 2024 · Are you a scientist in sterile product formulation and injectables eager to lead the development of life-changing drug products? Are you eager to unite science, talent, and technology to get ahea ...
Senior Associate Investigator

1 week ago

Dupont Wilmington, United States OTHER

En DuPont, trabajamos en cosas que importan, ya sea en proporcionar agua limpia a más de mil millones de personas en el planeta, producir materiales esenciales en los dispositivos tecnológicos cotidianos (desde smartphones hasta vehículos eléctricos) o proteger a los trabajadores ...
Principal Scientist/Investigator

1 week ago

GlaxoSmithKline Collegeville, United States Full time

Site Name: USA - Pennsylvania - Upper Providence · Posted Date: Jun 3 2024 · Are you a scientist in sterile product formulation and injectables eager to lead the development of life-changing drug products? Are you eager to unite science, talent, and technology to get ahead of dis ...
Investigator

4 weeks ago

GlaxoSmithKline Collegeville, United States Full time

Site Name: USA - Pennsylvania - Upper Providence · Posted Date: May · We currently have a vacancy on our team for an NMR spectroscopist focusing on small molecule structure elucidation. This is an exciting opportunity for an enthusiastic individual to join an NMR-focused team wi ...
Principal Scientist/investigator

1 day ago

GSK Collegeville, United States

**Site Name**: USA - Pennsylvania - Upper Providence · **Posted Date**: Jun · 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 toge ...
Investigator

1 week ago

GSK Collegeville, United States

**Site Name**: USA - Pennsylvania - Upper Providence · **Posted Date**: May 9 2024 · The position is within the MDS-AD-SFC Mass Spectrometry and Characterization (MSC) group, offering an opportunity to lead key activities essential for the progression of small and large molecule ...
Investigator

3 weeks ago

GSK Collegeville, United States

**Site Name**: USA - Pennsylvania - Upper Providence · **Posted Date**: Apr · We currently have a vacancy on our team for an NMR spectroscopist focusing on small molecule structure elucidation. This is an exciting opportunity for an enthusiastic individual to join an NMR-focused ...
Investigator, Cheminformatics

1 week ago

GlaxoSmithKline Collegeville, United States

Site Name: · USA - Pennsylvania - Upper Providence · Posted Date: · May · At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccine ...
Investigative Reporters

5 days ago

The Boston Globe Collegeville, United States

The Boston Globe is looking for an investigative reporter with a track record of high impact accountability work to join the storied Spotlight unit. · The ideal candidate should be adept at analyzing complex data, undaunted by having doors slammed in their face, skilled at storyt ...
Investigator, Cheminformatics

1 week ago

GlaxoSmithKline Collegeville, United States

Site Name: USA - Pennsylvania - Upper ProvidencePosted Date: May At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medici ...
Principal Investigator of Immunology

3 weeks ago

Piper Companies Philadelphia, PA, US, United States

Piper Companies is currently looking for an experienced Principal Investigator of Immunology in Philadelphia, Pennsylvania (PA) to work for an innovative and growing biotherapeutics company. The Principal Investigator of Immunology will play a significant role in the identificati ...

Investigator/Principal Investigator - Collegeville, United States - GlaxoSmithKline

Description

Investigator/Principal Investigator

Investigator/Principal Investigator

Investigator/Principal Investigator

Investigator/Principal Investigator

Investigator/Principal Investigator

Investigator

Investigator

Principal Investigator

Principal Investigator

Principal Scientist/investigator

Senior Associate Investigator

Principal Scientist/Investigator

Investigator

Principal Scientist/investigator

Investigator

Investigator

Investigator, Cheminformatics

Investigative Reporters

Investigator, Cheminformatics

Principal Investigator of Immunology

for Recruiters

Information