Scale-up Manager for Optimization & Statistics

Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

Our MS&T - Product Scale-up, Optimization & Statistics Team is looking for:

Scale-up Manager for Optimization & Statistics

Place of work: Vršac

Requirements:

• University Degree in the field of Pharmacy, Chemistry, Biology or related field;
• Minimum 3 years of experience in Pharmaceutical Development, Manufacturing or Quality Assurance
• Fluent English both verbally and in writing;
• IT Skills in MS Office and Statistics Software (MiniTab, Statistica);
• Good knowledge of EU Guidelines and of statistical process analysis;
• Reference: Fs5ZWN9ei_N9mGcNXXExio1rGwE-J2Hv4BEfyPXY8WE.

Your duties would include:

• Scale-up projects from lab-scale to commercial scale in the target sites;
• Involvement in Investigations on deviations;
• Lead Optimization projects to enhance product performance and/or to improve process and formulations;
• Run statistical assessments of the products and enable them for Ongoing Process Verification;
• Remove issues and barriers to successfully lead the projects;
• Derive Risk – Assessments that consider e.g. formulation, production process and the environmental conditions;
• Cooperate with manufacturing department and QA to implement the best possible solutions;
• Clarification of feasibility and execution of Scale-ups to the target site
• Check that GMP documents are correct for Scale-up and Optimization projects;
• Monitor and execute Process Challenge during production;
• Define requirements for stability studies (ICH, ongoing, bulk, transport studies)

We offer:

• Diverse, challenging and responsible tasks;
• Possibility of promotion and achieving a career progression;

For further information on Hemofarm, please visit the website hemofarm.com and