Analytical Development Technician

Chemo; Azuqueca de Henares; Presencial; EUR 45.000 - 70.000; Jornada completa

Descripción de la vacante

INSUD PHARMA, part of the Chemo group, seeks an Analytical Development Scientist to develop, validate and transfer analytical methods for injectable products and materials. You will support formulation development, stability studies, and QC activities, coordinating internal and external work to meet GMP timelines.

Please bring a MSc in Analytical Chemistry or Pharmacy and at least 3 years of hands-on experience in Liquid Chromatography within a GMP environment, plus strong English/Spanish

Formación

• MSc in Analytical Chemistry or Pharmacy required with strong analytical chemistry content.
• At least 3 years in pharmaceutical industry using LC/UPLC/HPLC in GMP environment.
• Experience with method validation and transfer to QC laboratories.
• Fluent English and Spanish written communication.

Responsabilidades

• Develop, validate, and transfer analytical methods for injectable drug products and materials.
• Support formulation development, stability studies, and QC activities with robust analytics.
• Coordinate internal and CRO analytical work in Spain and abroad.
• Ensure successful method transfer to Quality Control labs and write specs, reports, and bulletins.
• Review analytical results and coordinate lab analysts’ activities.
• Prepare documentation for regulatory and clinical activities and manage raw material testing.

Conocimientos

Analytical instrumentation

Chromatography

Mass Spectrometry

GMP/ICH knowledge

English and Spanish written

Educación

MSc in Analytical Chemistry or Pharmacy

Herramientas

HPLC/UPLC

Regulatory documentation tools

Descripción del empleo

Want to know more?

INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and expertise in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), and branded pharmaceutical products, adding value to human and animal health

INSUD PHARMA’s activity is organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 10,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical affiliates, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable developmen

What are we looking for?

We are looking for an Analytical Development Scientist to join our team and support the development of injectable drug products. In this role, you will be responsible for developing, validating, and transferring robust analytical methods for formulations and raw materials, ensuring compliance with project timelines, GMP standards, and regulatory requirements.You will play a key role in supporting formulation development, stability studies, quality control activities, and analytical investigations, while coordinating internal and external analytical work performed by CROs and partner laborator

The challenge!

• Develop, optimize, validate, and transfer analytical methods for injectable drug product formulations and raw materials.
• Support formulation development, stability testing, and quality control activities through reliable and robust analytical methodologies
• Coordinate and follow up analytical development, validation, and transfer activities performed internally or outsourced to CROs in Spain and other countries
• Ensure successful analytical method transfer to Quality Control laboratories.
• Perform analytical investigations and troubleshooting to support development, validation, and transfer activities
• Write and review analytical protocols, specifications, reports, and work bulletins.
• Evaluate analytical results and coordinate laboratory analysts’ activities.
• Review and report analytical work performed by other departments, group companies, and external third parties.
• Prepare analytical documentation to support regulatory and clinical activities.
• Manage verification and testing methods for raw materials in line with project deadlines.
• Coordinate and review the work carried out in the Analytical Development Laborlines.
• Oversee Analytical Development Laboratory equipment management.

Specific Knowledge:

• Strong knowledge of analytical instrumentation
• Solid expertise in chromatography techniques: LC, GC, and SEC.Good experience with Mass Spectrometry (MS).Sound knowledge of GMP, ICH, FDA, and USP/EP pharmacopeias
• Good spoken English and very strong written communication skills in English and Spanish fluency

Experience (years/area):

• At least 3 years of experience as an Analytical Development Scientist in the pharmaceutical in Industry at least 3 years of hands-on experience in Liquid Chromatography, within a GMP environment. Strong experience with HPLC; UPLC is considered
• Experience in the characterization of parenteral depot formulations is a a plus.
• Expertise in USP Type IV dissolution apparatus is a plus.
• EducationMSc in Analytical Chemistry or a related scientific discipline with strong chemistry content, or Pharmacy degree with relevant professional experience in analytical development.

Flexible start hours from Monday to Friday (full 40-hour

workweek).

Attractive salary package.

Company cafeteria (free of charge).

Benefits and Savings Club.

Development plans, internal mobility policy.

The Insud Pharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as established 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.