Senior/Director, Formulation Development & Manufacturing
The Director/Senior Director of Formulation Development and Drug Delivery will lead the comprehensive efforts in developing formulations, processes and drug delivery for clinical phase and life-cycle management projects using a rigorous science-based approach that is consistent with the company product strategy. The primary responsibility includes develop and align diverse delivery strategy for the company products, and execute the drug delivery strategy working with a cross-functional team. He/She will provide strategic direction, tactical oversight and technical expertise for all activities within the pharmaceutical development area and may participate in post-launch manufacturing trouble shooting and change management. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties & Responsibilities
- Responsible for conducting comprehensive evaluation of diverse drug delivery and/or device combination technologies and select ones best suited for the product plan
- Define and communicate development strategies, timeline and risks with the aim to rapidly progress to clinical proof-of-concept and ultimately to registration and commercialization
- Effectively apply expertise in pre-formulation, material characterization, drug delivery technologies, formulation development, variety of drug delivery approaches and overall drug development in providing drug products to meet project and patient needs
- Define a science-driven and risk-based pharmaceutical development strategy to deliver projects from early clinical stage to commercial launch, and incorporating Quality-by-Design, design of experiments approaches and computational modeling and simulation
- Manage budgetary, regulatory, and compliance systems within the framework of an internal/outsourced development and manufacturing business model.
- Creatively design complex formulations and delivery platforms using cutting edge technologies to enable clinically and commercially viable formulation and process in an efficient manner
- Generate intellectual properties during development
- Mentor a nimble and strong team of formulation scientists and build core drug delivery expertise within the company
- Identify and establish external drug delivery contract organizations or partners
Core Competencies, Knowledge and Skill Requirements
- Thorough understanding of the product development and pharmaceutical development processes
- Proven track record of solving complex formulation and delivery challenges efficiently to meet project needs
- Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Demonstrates a positive, ‘can do’ and service oriented attitude daily. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships to achieve deliverables.
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Ph.D. degree in Pharmaceutical Sciences, Pharmaceutical Technology, Chemical Engineering and related fields with 15+ years of working experience in formulation development, manufacturing and drug delivery
- Deep knowledge of modern pharmaceutical practices and techniques and solid scientific knowledge of pharmaceutical sciences and a good understanding of the drug development process.
- Experiences and deep understanding of formulation development and drug delivery technologies are requirement
- Extensive experiences in developing and registering parenteral formulation is required, and experiences in diverse drug delivery approaches are strongly preferred.
- Significant experience working in an outsourcing environment as well as building internal laboratories
- A strong track record of scientific achievements including external publications, patents and presentations
- Prior experience in successfully NDA/MAA submission and approval for new products
- Candidates should have advanced problem solving skills, strategic thinking, proven leadership, process optimization experience and outstanding written and verbal communication skills.