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Lipocine Inc. is a Clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA for TLANDO. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. TLANDO XR, a novel oral prodrug of testosterone, originated with and is being developed by Lipocine as a next-generation oral testosterone product with potential for once a day dosing. In a Phase 2 clinical evaluation when administered as one daily or twice daily, TLANDO XR met the typical primary and secondary endpoints. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA.

We invite self motivated professionals with excellent problem-solving, communication and interpersonal skills to join a group of world class scientists in finding practical drug delivery solutions for the future.

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.

The company has a highly competitive benefits package and is an equal opportunity employer.

If you have an interest in becoming a member of our team, please review our open positions and submit your resume for a position. Interested applicants can send their resume to admin@lipocine.com or:

675 Arapeen Drive, Suite 202
Salt Lake City, UT 84108
Phone: 801.994.7383

admin@lipocine.com

Open Positions

Director/Senior Director, Business Development and Alliance

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 Leader in Business Development and Alliance Management. Lipocine offers excellent growth opportunities and a competitive compensation and benefits package commensurate with expertise and is an equal opportunity employer.

Director/Senior Director responsible for Business Development activities within the company. In conjunction with executive leadership and other cross-functional business partners, this position is responsible for the identification, pursuit and acquisition of strategic business opportunities including mergers, acquisitions, partnerships, alliances, joint ventures, and licensing agreements that fit within the overall corporate strategy, business plan and product portfolio. In conjunction with senior leadership, this individual will assist in the development of short and long-range strategic plans for Lipocine.

This individual will collaborate cross-functionally with team members (Research, Development, Regulatory, Commercial, Finance, Legal, Intellectual Property, and other colleagues as appropriate) in the objective scientific and business assessment of third-party candidates in support of business opportunities. In conjunction with executive leadership, the position assists in the development and facilitation of product development strategic plan, identifying issues, and assisting in the implementation of solutions and the success of projects.

Essential duties and responsibilities include but are not limited to the following:

Structure and secure strategic partnerships, licensing agreements and promotion agreements to exploit new business opportunities by developing proposals with thorough financial and qualitative analysis, negotiating key business terms, and driving to contract execution.
In conjunction with executive leadership, lead and participate in the screening, identification, analytics, preliminary evaluation, and recommendation process of new business opportunities to in-license or acquire assets toward the goal of product development.
Support and participate in the screening, identification, and business evaluation of potential company or product portfolio acquisitions which complement strategic fit and/or fill existing gaps.
Present the justification of such opportunities to management for further evaluation.
Work with R&D and other relevant teams to monitor market/industry trends as well as evaluate, provide insight, and recommend new science and technologies which can complement current and future pipeline development needs.
In partnership with cross-functional colleagues, assist in identifying risks, solutions and risk mitigation strategies in the context of changing internal and external factors.
Facilitate timely and fact-based decision making.
In conjunction with executive leadership, foster relationships with third parties to enhance immediate awareness of market and business opportunities of all types.
Lead negotiations with third parties.
Alliance management of partnered products.

Requirements:

8-10+ years business development experience in Pharma/Bio industry.
Knowledge of Pharmaceutical product development and relevant scientific technologies.
Outstanding skills in communication, negotiation, strategy, financing, business, economics, leadership, critical thinking, and cross-functional partnering.
Interact with all levels of the company cross-functionally including the Executive Committee. Also interacts with KOLs, vendors, community leaders, business, scientific and physician thought leaders.
Experience in R&D, commercial, market research, or equivalent experience desirable.
Demonstrated negotiation skills.
Experience working in a deadline-oriented environment with a high attention to quality.
Exceptional multi-tasker who can set priorities, stay focused and meet key milestones.
Self-starter with the energy, drive, and determination to accomplish goals.
Collaborative team player who can motivate colleagues, lead cross-functional teams and drive toward objectives.
Travel and conference and meeting attendance required.
PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

Bachelor’s or an advanced degree in business/science preferred.

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.

Please email your CV to admin@lipocine.com, or fax to (801) 994-7388.

Formulation Lead

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

Please email your CV to admin@lipocine.com, or fax to (801) 994-7388.

regulatory affairs

Regulatory Affairs

Regulatory Affairs

Lipocine, an emerging leader in research and development of innovative products to treat metabolic and endocrine disorders, is seeking a self-motivated individual wanting to make an impact on a variety of therapeutic areas while growing professionally with the company.

Lipocine's clinical development pipeline encompasses a variety of programs at various stages, from Phase 1 through NDA submission. Lipocine’s pipeline includes therapeutics for men’s and women’s health including prevention of preterm birth, testosterone replacement therapy, postpartum depression, non-alcoholic steatohepatitis (NASH), and liver cirrhosis.

Job Summary:

Responsible for the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures that pre-clinical and clinical trial designs meet regulatory requirements. Provides advice to development on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Responsibilities

Keep abreast of current regulatory requirements and provide regulatory advice
Work on INDs, NDAs, CTAs, BLAs and MAAs in different regions around the world, including nonclinical, and clinical activities
Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development
Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams
Lead interactions with regulatory agencies for projects and products including liaising and negotiating with FDA, EMA and other HAs interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor
Independently lead the preparation and timely submission of regulatory filings, maintain existing products up to regulatory standards and plan for life cycle management
Provide regulatory affairs representation on project teams; lead regulatory sub-teams. Act as single point of RA contact on cross-functional teams; foster a global view as a member of the development team.
Works closely with all departments to coordinate all activities required to develop the product including clinical supplies on time and on budget.

Education and Experience

Advanced degree in a scientific discipline (e.g., Masters, Pharm.D., M.D., Ph.D.)
Experience in the pharmaceutical industry (at least two years), including regulatory interactions with FDA preferred
Deep and broad knowledge of regulatory affairs strategy; direct experience with pharmaceutical regulatory submissions and product approvals in the US. EU and global experience preferred.
A proven track record of effective collaboration with regulatory agencies, including the FDA
Experience with and line extensions strategy for marketed products preferred
Excellent verbal and written communication skills
Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
Ability to work with minimal supervision, to set priorities to meet timelines, to motivate others, and to manage budgets
Creative problem solving and strategizing abilities

About Lipocine

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. In national surveys, Salt Lake City generally rates in the top 10 locations to live.

Lipocine offers excellent growth opportunities and a competitive benefits package commensurate with expertise. This is an on-site position (no remote), at our Salt Lake City headquarters. Please email your CV to admin@lipocine.com, or fax to (801) 994-7388. Lipocine is an equal opportunity employer.

Endocrine/Metobolic Disorders

Scientist

JOB SUMMARY:

Candidate will be responsible for the conception and implementation of new research project ideas for the Lipocine Endocrine/Metabolic Disease area based upon an integration of biomedical knowledge, understanding of disease pathophysiology, current, and emerging medical practice, and commercial considerations.

Lipocine is committed to developing new treatments for Men and Women’s health disorders including inflammatory disease, liver fibrosis, and end-stage liver diseases including ascites, hepatic encephalopathy, portal hypertension, uterine disease and unmet needs related to pregnancy and uterine/endometrium disease.

RESPONSIBILITIES:

Cultivate effective partnerships throughout the Lipocine teams including the clinical development and commercial teams
Create a strong organizational alignment for new men and women health research programs through effective presentation of scientific and business cases to key decision-makers within Lipocine
Manage a project portfolio generated in-house and through external collaborations that are aligned with Lipocine’s strategy
Design and execute preclinical in vitro and in vivo experiments to support the clinical translation of portfolio projects
Identify and manage external collaborations with CROs and key opinion leaders at major academic research centers and facilitate the translation of their research results into portfolio projects
Initiate and introduce new scientific Concepts/ideas aligned with the business goals
Keep up-to-date in the Endocrine space by attending scientific conferences, reading relevant literature, and publishing novel research findings.

REQUIREMENTS:

Ph.D. in Life Sciences
At least 2 years of experience (biopharmaceutical industry, post-doctoral training) in target discovery and drug discovery
Experience in Non-alcoholic steatohepatitis is a plus
Strong background in the (patho) physiology of the Genito-urinary tract especially OB/GYN and the liver is preferred
Proven track record of executing innovative projects as indicated by an outstanding publication record and presentations at national conferences
Experience with working in cross-functional scientific teams with an understanding of chemistry, pharmacology, and ADME/PK disciplines
Hands-on experience with current state-of-the-art and emerging technologies including cell culture, flow cytometry, western blot analysis, ELISA, real-time PCR, RNAseq, and microscopy
Hands-on experience with relevant disease models
Capable of developing a strong translational network of academic partners in the Ob/Gyn & Hepatology area
Have good organizational and communication skills and can take the lead to coordinate activities within a research team
Ability to work on multiple projects through intense collaboration and to adapt priorities to achieve challenging deliverables
Bring new ideas and have strong creativity to tackle challenges issues
Excellent team player with an objective driven mindset
Excellent verbal and written communication skills as well as a good command in English (writing and speaking)

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