Analytical Development Technician

Galenicum; Esplugues de Llobregat; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

Galenicum, a rapidly growing pharmaceutical company, seeks an Analytical Development Technician to join their Laboratory Team. The role involves developing analytical methods for pharmaceutical ingredients and managing laboratory operations, requiring a strong educational background in life sciences. Ideal candidates should possess critical problem-solving skills, excellent communication abilities, and experience in GLP/GMP environments. Join a dynamic team that values talent and fosters growth.

Formación

• Minimum 2-3 years of experience in a GLP/GMP environment.
• Proven experience in developing and validating analytical methods.
• Excellent command of English and Spanish.

Responsabilidades

• Develop new analytical methods for various pharmaceutical forms.
• Manage and review documentation for analytical development.
• Collaborate in the preparation and submission of analytical dossiers.

Conocimientos

Analytical methods development

Problem-solving

Communication

Organizational skills

Educación

Degree in life sciences

Master's degree in Analytical Chemistry

Herramientas

HPLC

LC-MS

GC

UV

Statistical software

Descripción del empleo

BELIEVE IN LIFE. Join a company that takes you further!

Galenicum is one of the fastest growing companies in the pharmaceutical sector! We are enthusiastic about life, devoting our talent and effort to providing high-quality affordable pharmaceuticals worldwide.

People are the key to our present and future success, so we carefully select candidates that meet the requirements for each position, however most importantly, who also fit with our cultural DNA and values.

Here’s the lowdown on what your role will actually look like (spoiler alert: it’s awesome!)

We are looking for an Analytical Development Technician to join our Laboratory Team.

What you'll be rocking :

• Development of new analytical methods for active pharmaceutical ingredients, excipients, finished dosage forms, and cleanings.
• Execution of pre-validations and pre-forced degradation studies according to current guidelines supporting AVT team.
• Analysis of preliminary stabilities of developing products and review of stability results for dossier submission. Interpreting results and evaluating trends.
• Management and review of documentation provided by CROs and CMOs regarding analytical development.
• Support during process development and pilot production.
• Prepare and/or review technical protocols, reports, and Standard Operating Procedures (specifications and analytical methods) as needed.
• Respond to deficiency letters, regulatory agencies, and clients regarding analytical development activities.
• Leadership in decision-making regarding analytical development activities.
• Manage day-to-day operational aspects of projects and the laboratory, including analyst management.
• Collaborate in the tasks of elaboration, writing, and presentation of the analytical dossier of the company's products.
• Create a dynamic work environment.

What you bring to the table :

• Minimum 2-3 years of experience in analytical development in a GLP/GMP environment, with proven experience in developing and validating analytical methods such as HPLC, UPLC, LC-MS, GC, UV, potentiometric titration, KF titrations, and dissolution tests. PSD knowledge is valuable.
• Experience monitoring stability studies, analytical transfers from CROs to CMOs, and compiling technical documentation for international MA approval.
• Valuable knowledge of international guidelines (EMEA, FDA, ANVISA, ICH, ISO).
• Valuable knowledge of different pharmaceutical forms: tablets, capsules, injectable solutions, lyophilized products, etc.
• Experience with MS Office and statistical software.

Educational milestone :

• Degree in life sciences, preferably in Chemistry.
• Master's degree in Analytical Chemistry and/or Pharmaceutical Industry.
• Excellent command of English and Spanish, spoken and written.

Your key superpowers :

• Self-sufficient, critical, disciplined, confident, hardworking, creative, motivated, proactive, dynamic, methodical, organized, and decisive.
• Strong analytical and problem-solving skills.
• Excellent organizational, planning, and time management skills to design, monitor, and enforce work plans.
• Highly responsible and capable of working under pressure to meet deadlines.
• Ability to prioritize multiple tasks and execute projects on time in a fast-paced environment.
• Good team player with a collaborative working style.
• Detail-oriented professional with good communication skills.
• Ability to absorb, digest, and relate detailed scientific, quality, and regulatory information.
• Supportive and able to build effective working relationships throughout the organization.
• Excellent written and oral communication skills.
• Ability to increase technical knowledge and apply new skills.

We’re looking for someone who works hard, plays hard, and laughs harder. Sound like you?

Come aboard. Believe in life.