Pharmacometrician Scientist

Chemo; Azuqueca de Henares; On-site; EUR 55,000 - 85,000; Full time

Benefits offered by this job

Salary package

Benefits & Savings Club

Development plans

Internal mobility

Job summary

INSUD PHARMA is seeking a PK/biopharmaceutics specialist to support NME and complex generic projects. You will analyze drug properties, dissolution, and absorption, building IVIVC and PBPK models.

Strong PK, IVIVC, and PBPK experience, plus proficiency in R or Python and tools like Phoenix/NONMEM, is required. Fluency in English and working knowledge of Spanish are expected.

Qualifications

• Bachelor-level or higher degree in a relevant science.
• PhD in data modeling is a plus.
• Strong background in pharmacokinetics and IVIVC.
• Experience with PK/PD modeling and biopharmaceutics.

Responsibilities

• Provide technical and scientific support for NME and complex generic development projects.
• Identify relationships between drug substance properties, dosage forms, and absorption.
• Build mathematical models describing formulation effects on drug absorption (IVIVC/PBPK).
• Develop PK/PD models using in vitro dissolution data.
• Contribute to regulatory submissions with scientific reports.

Skills

Pharmacokinetics

IVIVC

In vitro dissolution

R or Python

PBPK platforms

English

Spanish

Education

University degree in Pharmacy/Bioinformatics/Biopharmaceutics

PhD in data modeling (a plus)

Tools

Phoenix

NONMEM

Simcyp

GastroPlus

PK-Sim

Job description

Experience: 2 to 4 years in similar roles.

Do you want to know more?

INSUD PHARMA operates throughout the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to both human and animal health.

INSUD PHARMA’s activity is structured into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 9,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and over 35 pharmaceutical subsidiaries, serving 1,150 clients in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.

Are you ready to be a #Challenger?

What are we looking for?

The challenge!

• Provide technical and scientific support for NME and complex generic development projects, driving appropriate biopharmaceutical assessment and contributing to the selection of formulation prototypes.
• Identify relationships between drug substance properties, dosage forms, drug release, and drug absorption.
• Build mathematical models describing formulation effects on drug absorption (IVIVC and PBPK models).
• Develop predictive PK models based on in vitro dissolution data (IVIVC).
• In collaboration with other team members, develop PK/PD models to address questions related to complex generic products.
• Contribute to the implementation of new tools and solutions to strengthen in vitro–in vivo relationships within the department.
• Author, review, and contribute to scientific documentation and technical reports to support regulatory submissions (including scientific advice packages and responses to deficiency letters).
• Interact and collaborate scientifically with internal cross-functional project teams and external partners.
• Maintain compliance with internal SOPs, regulatory guidelines (ICH, EMA, FDA), and GCP/GLP quality standards.

What do you need?

• University degree in Pharmacy, Bioinformatics, Biopharmaceutics, or other related sciences.
• PhD in data modeling or related field is a plus.
• Strong background in pharmacokinetics and IVIVC.
• Knowledge of in vitro dissolution testing (biorelevant/biopredictive API and formulation testing).
• Hands-on experience with programming languages such as R or Python.
• Experience with pharmacometric and PBPK platforms such as Phoenix, NONMEM, Simcyp, GastroPlus, PK-Sim, or equivalent tools.
• High level of English (spoken and written).
• Intermediate level of Spanish.

Flexible entry schedule from Monday to Friday (full-time, 40 hours).

Attractive salary package.

Benefits & Savings Club.

Development plans, internal mobility policy.

And many more!

How will the selection process be?

Stay alert to your phone and email! Most likely, the first thing we will do is contact you through one of these channels.

Get ready! We will continue with an in-person/virtual interview depending on availability and as we agree; the process may include one or two interviews, and depending on the type of process, there may also be some sort of test.

Wait for the result! We care that in each selection process you feel guided and know what to expect from us, so we will try to inform you about the status of the process at all times.

Do you think this offer is not for you?

Follow us on social media like LinkedIn/Instagram and stay tuned for any openings we post: the opportunity to become a new Insuder is waiting!

COMMITMENT TO EQUAL OPPORTUNITIES

The InsudPharma group is aware that business management must be in harmony with the needs and demands of society, and therefore undertakes a commitment to equal opportunity and treatment between men and women, as set out in current regulations—Organic Law 3/2007—and we do not discriminate against anyone based on ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.