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Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107. LPCN 1021, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. LPCN 1021, was well tolerated and met the primary efficacy end-point in Phase 3 testing, which utilized 24-hour pharmacokinetic data for dose adjustments, and is currently being studied in two additional Phase 3 clinical trials. LPCN 1111, 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-daily dosing and is currently in Phase 2 testing. LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preteen birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed.
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. An additional commercial office is located in Lawrence, New Jersey.
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 email@example.com or:
675 Arapeen Drive, Suite 202
Salt Lake City, UT 84108
MANAGER, ANALYTICAL RESEARCH AND DEVELOPMENT
November 11, 2013
JOB SUMMARY :
Responsible for the design and conduct of all analytical activities including scheduling, planning, and monitoring the operations of the department to ensure that the analytical functions are accomplished with high scientific quality and in compliance with all applicable regulatory requirements, while meeting company timelines.
ESSENTIAL FUNCTIONS :
1. Development of analytical methods for excipients, API, intermediates and products.
2. Validation of analytical methods, and the successful transfer of methods to Partner/Contract Manufacturer.
3. Testing and release of excipients, API, intermediates and product for clinical supplies manufacture and clinical studies.
4. Conduct of stability testing on API, intermediates and finished product in development.
5. Prioritization of the analytical workload in the group.
6. Implementation of new analytical techniques, laboratory equipment/automation which improve the efficiency/productivity of the laboratory.
7. Ability of handle multiple projects with tight/overlapping timelines.
8. Represents Lipocine at scientific, partner, contractor or regulatory meetings as appropriate.
ADDITIONAL RESPONSIBILITIES :
1. Effectively manage and supervise analytical chemists and serve as mentor and aid in the development of analytical chemists.
2. Select and manage the use of outside contract laboratories to effectively extend the analytical capabilities of the laboratory.
3. Design/upgrade appropriate laboratory facilities to meet lab objectives.
4. Maintain effective communications with appropriate managers so that a team working environment is created for the development and registration of new products.
QUALIFICATIONS (EDUCATION/EXPERIENCE REQUIREMENTS) :
Ph.D. in Analytical Chemistry with 3-6 years experience in product development in the Pharmaceutical Industry
Very strong background in analytical chemistry and experienced in development/validation of various analytical methods for pharmaceutical products
Knowledge of cGMPs/GLPs and FDA guidelines as they relate to method development/validation and product registration
Ability to work well in a team environment and demonstrated effectiveness in oral and written communication skills with good sense of business aspects of innovation and product development
Knowledge and familiarity with outside contract laboratories and their capabilities
Knowledge and familiarity with overall pharmaceutical product development process and regulatory requirements particularly as they relate to CMC issues
Supervisory experience and laboratory management experience desirable
PHYSICAL OR MENTAL CRITERIA :
- Must possess excellent communication and team building skills.
- Motivated, self-starter with drive and ambition.
- Ability to interpret an extensive variety of analytical data.
- Ability to interface with other departments, consultants, contractors and partners.
RELATIONSHIPS AND CONTACTS :
- Lipocine coworkers, consultants, and management.
- Clinical and bioanalytical contract laboratories and consultants.
- Lipocine product development and commercialization partners.
- Other associations as assigned.