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Open Positions

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 lead product candidate, LPCN 1021, demonstrated positive top-line efficacy results in Phase 3 testing and is targeted for testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth, and is currently in Phase 1 testing.

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. Three or more years of experience in the drug delivery product development process is an advantage.

Lipocine 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



OPEN POSITIONS

LEADERSHIP POSITION, CLINICAL RESEARCH AND DEVELOPMENT

JOB SUMMARY :

Responsible for the design and conduct of all clinical studies including development of the study protocol, evaluation of and selection of the bioanalytical and clinical CROs, monitoring study conduct, perform required analysis and prepare draft and final clinical study reports including presenting it to regulatory authorities, partner and scientific/investment community.

ESSENTIAL FUNCTIONS :

1. Design and prepare clinical development strategies/study protocols.
2. Identify and interact with consultants/thought leaders to design study protocols.
3. Proactively identify challenges and opportunities in clinical development.
4. Evaluate and select clinical and bioanalytical CROs and monitor study conduct.
5. Perform analyses; write draft and final study reports.
6. Ensures GCP compliance and writes documents for regulatory submission.
7. Work as part of a multidisciplinary team (including consultants and/or partners) to support development of product candidates.
8. Manage multiple projects simultaneously.
9. Identify and champion innovative therapeutic opportunities consistent with company business plan including evaluation of published development and innovation.

ADDITIONAL RESPONSIBILITIES:

1. Select and manage the use of CROs and consultants for timely project completion.
2. Conduct CRO compliance audits, site monitoring and/or inspections when needed.
3. Responsible for writing all clinical sections of regulatory submissions.
4. Hire/train/manage clinical associates as needed to assist in Lipocine clinical development.
5. Budgeting and budget monitoring in the clinical development area.
6. Performs other duties as assigned by supervisor.

QUALIFICATIONS (EDUCATION/EXPERIENCE REQUIREMENTS) :

  • Pharm.D or Ph.D. in Clinical Pharmacology, Pharmacokinetics or related field with 3-6 years of relevant pharmaceutical clinical trials experience.
  • Knowledge/experience of biostatistics and state of the art statistical/data management methods and packages essential.
  • Knowledge of bioanalytical methods, method development/validation requirements highly desirable.
  • Strong background in PK/PD modeling is preferred.
  • 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/experience in the design of clinical safety and/or efficacy trials preferred.
  • Familiarity with other product development and regulatory functions.

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 preclinical and clinical 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.
 

MANAGER, ANALYTICAL RESEARCH AND DEVELOPMENT

Reports To:
Department:
Date:
Vice President, R&D
Analytical R&D
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.