Associate Director/Director, Product Development

Lipocine Inc.; Salt Lake City (UT); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Lipocine Inc. in Salt Lake City, Utah, is seeking an Associate Director/Director, Product Development to lead the drug product development team across programs, from formulation to manufacturing.

This full-time role offers growth opportunities and a competitive compensation package. The position requires PhD or MS in pharmaceutical sciences/chemistry/chemical engineering with industry experience (5+ years with PhD or 8+ years with MS).

Qualifications

• PhD or MS in pharmaceutical sciences/chemistry/chemical engineering/related field with industry experience in drug product development (5+ years with PhD or 8+ years with MS).
• Direct, hands-on experience in formulation development and manufacturing of solid and liquid oral dosage forms.
• Working knowledge of chemical and physical properties of APIs and excipients in relation to drug product development.
• Thorough understanding of current formulation technology platforms and analytical characterization techniques, including DSC, XRPD, microscopy, HPLC, Dissolution, LOD, Density tester, Friability tester etc.
• Prior experience with CROs/CMOs is highly desirable.
• Excellent communication skills, problem solving, critical thinking, team and organization skills.

Responsibilities

• Lead the drug product development team for assigned programs.
• Conduct activities related to formulation development under research and development settings
• Carry out pre-formulation required for the assessment of developability of an API, including solution and solid-state characterization studies, solubility/solubility enhancement studies, compatibility studies, polymorph and salt screening and characterization, particle size analysis, assessment of bulk properties of powders etc.
• Design and execute detailed experiments developing formulation and manufacturing process under QbD principles and transferring these methods and processes to drug product manufacturers.
• Lead the design, development and manufacturing of preclinical formulations and early clinical supplies.
• Oversee and troubleshoot various developmental and manufacturing activities at CMOs.
• Author/review manufacturing batch records, SOPs, technical reports such as formulation development report and other relevant scientific information packages for internal use or agency submissions.
• Critically assess experimental data and provide interpretation of results.
• Establish work schedules to ensure timely completion of the required activities.
• Work collaboratively with analytical R&D, pre-clinical, and clinical teams.
• Other relevant duties as assigned.

Skills

Communication

Problem solving

Teamwork

Organization

Education

PhD or MS in pharmaceutical sciences/chemistry/chemical engineering/related

Job description

Associate Director/Director, Product Development

Lipocine Inc. (NASDAQ: LPCN - www.lipocine.com) is a publicly traded biopharmaceutical company developing innovative products to treat neuroendocrine and metabolic disorders. We are currently seeking a qualified, self-motivated, excellent team player who exhibits outstanding communication and interpersonal skills to grow with the company as a full-time Associate Director/Director, Product Development. Lipocine offers excellent growth opportunities and a competitive compensation and benefits package commensurate with expertise and is an equal opportunity employer.

Primary Responsibilities

• Lead the drug product development team for assigned programs.
• Conduct activities related to formulation development under research and development settings
• Carry out pre-formulation required for the assessment of "developability" of an API, including solution and solid-state characterization studies, solubility/solubility enhancement studies, compatibility studies, polymorph and salt screening and characterization, particle size analysis, assessment of bulk properties of powders etc.
• Design and execute detailed experiments developing formulation and manufacturing process under QbD principles and transferring these methods and processes to drug product manufacturers.
• Lead the design, development and manufacturing of preclinical formulations and early clinical supplies.
• Oversee and troubleshoot various developmental and manufacturing activities at CMOs.
• Author/review manufacturing batch records, SOPs, technical reports such as formulation development report and other relevant scientific information packages for internal use or agency submissions.
• Critically assess experimental data and provide interpretation of results.
• Establish work schedules to ensure timely completion of the required activities.
• Work collaboratively with analytical R&D, pre-clinical, and clinical teams.
• Other relevant duties as assigned.

Qualifications

• PhD or MS in pharmaceutical sciences/chemistry/chemical engineering/related scientific discipline with industry experience in drug product development (5+ years with PhD or 8+ years with MS) preferred.
• Direct, hands-on experience in formulation development and manufacturing of solid and liquid oral dosage forms is required.
• Working knowledge of chemical and physical properties of APIs and excipients in relation to drug product development, process and drug delivery.
• Thorough understanding of current formulation technology platforms and analytical characterization techniques, including but not limited to DSC, XRPD, microscopy, HPLC, Dissolution, LOD, Density tester, Friability tester etc.
• Prior experience with CROs/CMOs is highly desirable.
• Excellent communication skills, problem solving, critical thinking, team and organization skills.

About Lipocine

Lipocine Inc. is a biopharmaceutical company developing innovative pharmaceutical products for neuroendocrine and metabolic disorders using its proprietary drug delivery technologies. Lipocine's product and product candidates include: TLANDO, an FDA approved differentiated oral product to treat hypogonadism and the R&D portfolio comprising of LPCN 1148 for treatment of liver cirrhosis, LPCN 1144 for treatment of non-cirrhotic NASH (nonalcoholic steatohepatitis), LPCN 1111, a novel once a day treatment for symptoms of low testosterone for men, LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth, LPCN 1154 for at-home treatment of postpartum depression, and LPCN 2101 for treating women with epilepsy.

Lipocine's corporate office is based in scenic Salt Lake City, Utah, which is near a variety of internationally recognized summer and winter parks and recreation areas. Salt Lake City generally rates in the top 10 locations to live in national surveys.