Drug Research and Development Team Lead

Off Targets is a leader in pharmaceutical innovation, committed to developing advanced therapeutic solutions that address unmet medical needs. We are looking for an experienced and dynamic professional to lead our Formulation Development department, driving the development of cutting-edge injectable drug products.

Job Description:
We are seeking a highly skilled and experienced Team Lead for our Formulation Development departmentto oversee our formulation development activities, particularly focusing on complex injectable forms. The ideal candidate will have 10-15 years of experience in pharmaceutical formulation, with at least 10 years dedicated to developing complex injectable products. This role requires expertise in 505(b)(2) development, in-depth knowledge of regulatory requirements (FDA, EMA), and a proven track record of managing high-performing teams. The position demands excellent communication, business acumen, and leadership skills.

Role & responsibilities

• Lead and manage the Formulation Development department, overseeing the development of complex injectable drug products, including emulsions, nanoformulations, and lyophilized forms.
• Drive the 505(b)(2) development process, ensuring compliance with FDA and EMA regulations and guidelines.
• Provide strategic direction and technical expertise to the formulation team, fostering innovation and ensuring the successful execution of projects.
• Collaborate with cross-functional teams, including R&D, analytical, regulatory, and manufacturing, to ensure seamless product development and commercialization.
• Prepare and deliver high-quality presentations, technical reports, and business proposals to internal and external stakeholders.
• Develop and implement departmental goals, budgets, and timelines, ensuring alignment with overall company objectives.
• Mentor and develop team members, building a high-performance culture focused on excellence and continuous improvement.
• Represent the Formulation Development department in meetings with senior management, regulatory agencies, and external partners.

Critical Skills

1. Expertise in Complex Injectable Formulations

• In-depth Knowledge: Extensive experience in developing complex injectable drug products, including emulsions, nanoformulations, and lyophilized forms.
• 505(b)(2) Development: Proficiency in 505(b)(2) development pathways, with a thorough understanding of the associated regulatory requirements.

2. Regulatory Knowledge

• FDA and EMA Regulations: Strong knowledge of FDA and EMA guidelines, ensuring that all formulation development activities comply with global regulatory standards.

3. Leadership and Team Management

• Team Leadership: Proven ability to lead and manage high-performing teams, fostering a culture of innovation, collaboration, and continuous improvement.
• Mentorship: Experience in mentoring and developing team members, building a skilled and motivated department.

4. Strategic and Business Acumen

• Strategic Thinking: Ability to develop and implement strategic plans for the Formulation Development department, aligning with overall company goals.
• Business Skills: Strong business acumen, with the ability to prepare and deliver business proposals, manage budgets, and contribute to the companys financial success.

5. Communication and Presentation Skills

• Excellent Communication: Superlative written and spoken English skills, with the ability to communicate complex technical and regulatory information clearly and effectively.
• Presentation Skills: Proficiency in preparing and delivering high-quality presentations and reports to both technical and non-technical stakeholders.

6. Problem-Solving and Innovation

• Innovative Thinking: Ability to drive innovation in formulation development, applying new technologies and methodologies to improve product performance.
• Problem-Solving: Strong analytical skills to identify and resolve complex formulation and process-related challenges.

7. Cross-Functional Collaboration

• Interdepartmental Coordination: Ability to work effectively with cross-functional teams, including R&D, regulatory, manufacturing, and commercial teams, to ensure seamless project execution.

8. Soft Skills

• Influence and Persuasion: Ability to influence decisions and lead discussions at the senior management level.
• Adaptability: Flexibility to adapt to changing priorities and challenges in a dynamic R&D environment.

Preferred candidate profile

• Ph.D. or Masters degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
• 10-15 years of experience in pharmaceutical formulation development, with a minimum of 10 years focused on complex injectable forms.
• Proficient in 505(b)(2) development, with a strong understanding of FDA and EMA regulatory requirements.
• Proven experience in leading and managing teams, with a demonstrated ability to drive projects to successful completion.
• Excellent communication skills, with a strong command of written and spoken English.
• Proficiency in preparing and delivering professional presentations, reports, and business proposals.
• Strong business acumen and soft skills, with the ability to influence and lead in a cross-functional environment.

Perks and benefits

• Opportunity to lead a key department in a forward-thinking pharmaceutical company.
• A collaborative and supportive work environment that encourages professional growth and innovation.
• Competitive salary and benefits package, with opportunities for advancement.
• Access to state-of-the-art facilities and cutting-edge technology.

How to Apply:

Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to

business@offtargets.com