Head of Pharmaceutical Development

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.

Head of Pharmaceutical Development
Place of work
: Vršac (Commute or Relocation)

About the job:
This role is a cornerstone in leading, designing and overseeing the development, communication and implementation of pharmaceutical development short, mid and long term strategy in support of internal product development programs/projects in accordance with the global/local portfolio strategy, any applicable regulatory requirements and/or local rules and industrial requirements, to fulfill patients/consumers, health care professional and payers' needs. In addition, this role oversees commercial manufacturing operations at pilot scale.

Responsibilities:

• Act as Leader, driven by a growth and entrepreneurial mindset, in line with STADA values, stimulating a "learning and entrepreneurship culture"
• Implement tailored personal development plans, local and global succession plans, robust performance management, while continuously adapting the organization to Global Product Development strategy
• Propose the strategic plan of the Site aligned with the Global Product Development strategic plan and ensures its execution
• Elaborate and present the budget of the Site (OPEX/CAPEX) and ensure continuous monitoring, escalade in due time of any shift
• Design and lead pharmaceutical development programs in line with business priorities, striving for innovation and improved solutions (e.g., dosage form, dose regimen, delivery system, packaging) as well as excellence in project execution
• Responsible for the conception, design, and interpretation of scientific and technical data to support projects decision making
• Deliver robust, scalable and cost-effective drug product formulation, manufacturing process and control strategy
• Ensures close liaison with Technical Operations to prepare, execute and support technical transfer to the late stage of development addressing optimized cost of goods and process robustness
• Act as a voice and ambassador of the department in various governance bodies / meetings, supporting business case elaboration and presentation
• Ensure that projects are run according to TPP, timelines, budget, quality/regulatory and safety requirements
• Ensure a high level of adherence to standards and guidelines that apply to the activities (e.g. Standard Operating Procedures, GMP, HSE)
• Review and approve, if applicable, standard operating procedures and working instructions required by the activities
• Scout, benchmark cutting-edge and specific technologies, and ensure knowledge acquisition
• Maintain current awareness of GMP and other regulations, guidance documents, advisory committees, industry standards, scientific literature and trends that are applicable to current and future operations and products
• Proactively contribute to implement regional regulatory requirements and guidelines that impact Pharmaceutical Development (e.g. EMA, ICH)
• Identify and attend congresses, conferences and training courses to ensure continuous expertise growth
• Develop and recommend strategy to circumvent relevant patents and patent applications, to submit own patent applications and/or defense in close cooperation with Industrial Property Team
• Support Business Development with technical and commercial due diligence on new external opportunities as required
• Contribute on request to out-licensing projects
• Ensures monthly reporting of the assigned projects portfolio and activities, by updating Global Product Development Dashboard as well as KPIs

Qualifications:

• Pharmacist, MSc and/or PhD, with a minimum of 10Y pharmaceutical industry experience supporting worldwide pharmaceutical development and notably generic and hard-to-make generic
• Demonstrated understanding of drug substance and drug product pharmaceutical development of generic and hard-to-make generic with different dosage forms from laboratory scale to industrial scale
• Demonstrated experience in developing and implementing development work plans to support phase appropriate activities, including management of timelines and budget
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported
• In-depth knowledge in developing and implementing risk management
• Strong experience in authoring/reviewing regulatory documents and in supporting registration process
• Proven experience in designing and implementing industrial property (IP) strategy
• Strong personal leadership, Team management and interpersonal skills
• Excellent verbal and written communication (English)
• Demonstrated knowledge of cGMP requirements, ICH guidelines, Medical Devices and HSE regulations.
• Entrepreneurial mindset, creative thinking and innovation leadership
• Change management leader

We offer:

• Private healthcare insurance (with the option of privileged usage for family members)
• Ongoing professional development through specialized education and training
• A platform for learning 14 foreign languages, using various learning styles, including conversation courses
• Personalized mental health and well-being support for employees and their families through the Kyan Health app

Only shortlisted candidates will be contacted.