Director of Formulation Development

• The Director of Formulation will oversee small molecule development (Oral Solids, Tablets, Capsules) with a preference for Extended/Modified Release.  Any experience with Sterile Dosage Forms will be a plus.
• The Director of Formulation will focus on early-stage development (Lab Scale) as well as helping to determine the best process for Scale-Up.  Additionally, they will be responsible for assessing the capabilities of third party CROs/CDMOs.
• Provide leadership to Scientists when appropriate
• Direct formulation team to design and perform laboratory experiments leading to acceptable product formulation and processes
• Perform literature and patent search to support strategies and studies for development of company pipeline products
• Assist with various stages of product development, including pre-formulation, formulation development, process development, optimization, scale-up studies/technology transfer with CROs/CDMOs
• Generate data/development reports for each stage of the product development
• Support regulatory submissions
• Collaborate with other functional groups (Analytical, QC, QA, Clinical, Regulatory, Production) to advance the development of Company pipeline products

Qualifications

• The qualified candidate will have a Ph.D. or M.S in Chemistry with 10+ years of experience working for pharmaceutical companies to develop and improve formulations that are delivered as small molecule oral solid/liquid dosage as well as sterile dosage forms.
• The person must also be familiar with scale-up techniques used to produce larger quantities without compromising quality.
• Hands on experience in R&D of small molecule formulations in a cGMP environment
• Solid knowledge and training on cGMP & GLP regulations
• Excellent communication skills (Written and verbal)

• Ability to perform and bring out the best in others on a cross-functional global team
• Ability to interact externally and internally to support a global scientific and business strategy