Position: Director or Associate Director, Formulations
Reporting To: Vice President, Pharmaceutical Sciences
This position is for a scientific leader who has broad and deep expertise in Lipid Nanoparticle (LNP) formulation design and development. You will be part of the management team and direct a group of scientists to develop novel lipid nanoparticles for systemic nucleic acid delivery and cellular targeting.
• Scientific foundation in a fundamental physical science such as chemistry or chemical/biomedical engineering or pharmaceutics.
• Understanding of the interface of biology and physical sciences to develop systems for RNA delivery within mammals.
• Leadership to bridge drug product development activities from early development (research) though full clinical and commercial activities.
• Serve as the pharmaceutical development representative for internal and partnered project teams, assuring alignment of work scope to resources and budget.
• Manage and develop a team of formulation staff that is matrixed across multiple programs.
• Lead budgeting and staff recruitment and development to ensure a high performing formulation and drug product development team.
• Oversee the requisite lipid nanoparticle (LNP) formulation development work suitable for the intended clinical dosage form while leveraging and adding to the existing DDS platform knowledge to be used in early stage or full development programs.
• Design novel lipids, formulations, and delivery concepts
• Assure formulations meet requirement for pharmacology, preclinical-tox, and clinical development are suitable clinical dosage forms utilizing the appropriate route of administration.
• Ensure timeliness and continuity of research and development drug product supplies with appropriate controls for internal and partnered programs.
• Knowledge of analytical methods for testing lipid nanoparticles.
• Expertise in RNA LNP delivery systems incorporating polymers, conjugates and small molecules.
• Effectively collaborate with chemistry R&D, analytical R&D, and process R&D to ensure appropriate engagement of contract manufacturing organizations (CMO) in line with internal and partner timelines and associated contract facilities.
• Ensure creation of drug product CMC regulatory submission sections for clinical and commercial applications meeting GMP compliance to 21CFR part 211 (quality system regulations) for oligonucleotide and/or mRNA lipid-based drug products.
Education and/or Experience:
• Candidate will possess a Ph.D.in Pharmaceutics, Chemistry, Chemical or Biomedical Engineering or related field with a minimum 10 years of experience in leading formulations programs for the biotechnology/pharmaceutical industry.
• At least 5 years’ experience in pharmaceutical technical development disciplines
• At least 3 years of leadership experience at the department and/or larger team level, including recruiting/coaching high performing teams and creating/managing program budgets
• Extensive experience designing and developing sterile parenteral / injectable drug products, including
o Research and development for novel parenteral formulations and routes of delivery
o Prior experience developing mRNA or oligonucleotides is a strong plus
• Demonstrated general ability to apply fundamental scientific and engineering know-how to generate innovative yet practical solutions to technical challenges.
• Expert at defining and leading cross-functional drug product development functions from preclinical through commercial launch: manufacturing, specifications, development studies, stability, shelf-life, etc.
• Previous experience with writing regulatory submissions is essential
• Excellent communication and interpersonal skills are required
• Project management and team leadership skills
Physical Job Requirements:
• Travel 10%
• Mandatory Covid-19 Vaccination Policy in effect
• Office/Lab environment. Lifting up to 20 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. They are required to stand, walk or sit, reach with hands and arms, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.
Date Job description Created:
Disclaimer: The duties and responsibilities of position may change as need arises. The employee will be notified of the change. Relevant work experience may also be substituted for education or certification, at company’s discretion.
Nitto BioPharma, Inc. is a clinical stage biopharmaceutical company located in San Diego focused on the discovery and development of novel RNA-based therapeutics for intractable diseases. Nitto BioPharma offers unique RNA drug and its delivery solutions by designing novel biodegradable drug delivery systems with the ability to target specific cells and efficiently deliver the cargo into the cells. Clinical assets include two Phase 2 clinical programs, a first-in-class drug for the treatment of liver fibrosis (with Bristol-Myers Squibb), and idiopathic pulmonary fibrosis, as well as a Phase 1 oncology program to treat non-small cell lung cancer.
Nitto BioPharma's mission is to develop and deliver innovative life-transforming therapies for patients with unmet medical needs. Leveraging the long-standing success and track record of Nitto Denko Corporation (Nitto), Nitto BioPharma has created a new and efficient business unit that allows pharmaceutical products to be brought to market at a fast pace. Our long-term vision and unparalleled, multi-disciplinary team of researchers from all over the globe make Nitto BioPharma a vibrant and exciting work environment.
Nitto BioPharma is a key asset of Nitto. Since its establishment in 1918, Nitto has created over 13,500 products based on its core technologies and has contributed to customers' value creation with innovative ideas. The core of Nitto's life science business consists of contract manufacturing and drug discovery.