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.

Formulation and Manufacturing Process Development Manager

Place of work: Belgrade/Vršac

About Job:

The role leads new product formulation and process development by establishing strategic direction and implementing production processes in lab and pilot environments. It involves supervising departmental operations, guiding team development, and ensuring efficient workflows aligned with product portfolios. Key responsibilities include creating and supporting scientific data for development reports, managing regulatory compliance, supporting training programs, and participating in budget preparation and improvement initiatives. The position also requires effective communication of technical issues to management and collaboration with other units to achieve shared objectives.

Responsibilities:

• Lead new product formulation and process development by setting strategic direction at all project phases
• Utilize expert knowledge to implement technology-related production processes in laboratory and pilot plant settings
• Provide guidance and relevant documentation to resolve complex formulation and process development issues
• Define and implement the intellectual property strategy
• Organize workflows in the Formulation and Process Development department to align with product development portfolios and optimize use of resources
• Supervise departmental employees to ensure efficient operations
• Participate in departmental recruitment and development planning for team leaders and experts
• Set personal yearly targets and evaluate achievements for the team
• Support training programs to enhance expertise while ensuring compliance with guidelines and SOPs
• Ensure tasks are executed properly, reporting risks and implementing mitigation plans
• Compile scientific data, prepare technical reports, and facilitate regulatory filings
• Collaborate with other organization units to achieve shared goals
• Stay informed on formulation and process development stages and global regulatory trends for quality submissions
• Drive continuous improvement in technologies and processes related to formulation and documentation
• Manage and assess GMP-relevant data for development projects per regulatory standards.
• Review registration documentation for marketing authorizations and support regulatory inquiries
• Contribute to budget preparation and monitor functional area performance
• Author and review scientific papers and patent applications, promoting participation in professional seminars
• Monitor trends in relevant fields and implement employee education on formulation and development
• Communicate effectively on complex technical issues with management and stakeholders
• Continuously improve operational processes within the department

Requirements:

• Ph.D. in Pharmaceutical Sciences (Pharmaceutical Technology) or equivalent experience (e.g., Pharmacist, Chemical Engineer)
• At least 10 years of experience in the pharmaceutical industry in a formulation environment and track records in development of generic and hard-to-make generic medicinal products
• Expert knowledge in formulation development of solid dosage forms (immediate and modified release) and ideally in formulation development of parenteral dosage forms (e.g., long acting injectables)
• Demonstrated experience in definition and implementation of intellectual property strategy
• Experience in developing and optimizing pre formulation, formulation and manufacturing process for generic drug products using tools as design of experiment (DOE), quality by design (QbD) and any machine learning system
• Experience in scaling up manufacturing process from laboratory scale to pilot scale and then to the industrial scale
• Familiarity with the regulatory and quality requirements and standards for generic medicinal drug development and manufacturing such as GMP, ICH, Qualification & Validation, EMA Guidelines, Health, Safety and Hygiene
• Experience in writing patents, scientific publications, posters
• Proven records of success in driving innovation and change management, with ability to operate in a fast-moving environment
• Strong problem-solving skills with a focus on innovative solutions and strategic thinking
• Effective collaboration in multidisciplinary teams, fostering empathy and relationship-building
• Proficient in project and budget management, with the ability to manage competing priorities
• Excellent verbal and written communication skills in English, along with strong presentation abilities
• Entrepreneurial mindset with a commitment to accountability, integrity, and a focus on precision and quality

We offer:

• Continuous learning environment
• Chance for a professional and personal development
• Private health insurance
• Language learning platform for 14 languages with vast type of written and conversational courses
• Personalized mental health and wellbeing support for our employees and their families via Kyan Health application