Senior Scientist, Product Development, R&D, Lipocine, Inc

 

Job Title: Senior Scientist, Product Development, R&D, Lipocine, Inc.

Lipocine, Inc. seeks a highly motivated, self – initiated, excellent team player who exhibits outstanding communication and interpersonal skills to grow with and part of the fast growing pharmaceutical / drug delivery company.

SAILENT RESPONSIBILITIES INCLUDES:

·        Identifying and proposing suitable product development opportunities based on available clinical trial data, relevant patent information, technical feasibility and potentially market viability in the literature

·        Developing intellectual property offerings that combine technical innovation and real-world experience

·        Developing new products by creating and expecting project plans to include interaction with customers, literature searches, laboratory & pilot experimentation, and cooperation with support groups to meet timing, budget and product performance expectations

·        Conceptualizing, formulating, developing and evaluating pharmaceutical dosage forms and products.

·        Executing leadership qualities / skills to manage an excellent pool of product development scientist

·        Writing SOPs, work instructions for laboratory, technical reports and other documents necessary for product submission to FDA and equivalent regulatory agencies

·        Perform all documentation practices in compliance with cGMP

·        Supporting and coordinating with various work forces such as marketing, operations, engineering etc… within Lipocine, Inc. or other contract manufacturing organizations

·        Participating and contributing in training of Product Development group and getting involved in other relevant product development activities and opportunities

 

BASIC QUALIFICATIONS

·        Ph.D. in pharmaceutics or relevant field with minimum of 3 years of experience (preferably in formulation designing and execution which includes preformulation and formulation related to pharmaceutical product development)

·        Experience with HPLC, related spectroscopy and other common analytical methods and experience in manufacturing of dosage form for clinical trials and scaling up to commercial scale is preferred

The position is technically detailed, requiring the services of an individual who can qualify as a specialist, with a minimum of three years of product research and development experience. This technical position requires advanced educational training and experience.

 

Analytical Scientist / Manager, Product Development, R&D, Lipocine, Inc

 

Job Title: Analytical Scientist / Manager, Product Development, R&D, Lipocine, Inc.

Lipocine, Inc. seeks a highly motivated, self – initiated, excellent team player who exhibits outstanding communication and interpersonal skills to grow with and part of the fast growing pharmaceutical / drug delivery company.

SALIENT RESPONSIBILITES INCLUDES:

·        Develop method for stability indicating assay, related compounds and drug product dissolution analysis

·        Execute routine analytical work on a wide range of projects in product development.

·        Support formulators in their formulation & process development, conducting stability, manufacturing support and regulatory filings.

·        Conduct wet-chemical tests, titration and other common analytical methods such as utilizing HPLC.

·        Generate and collate the data, perform required calculations, record experiments in a laboratory notebook following GMP / GLP practices.

·        Calibrate and maintain analytical instruments and recommend improvements when necessary.

·        Write and follow SOPs, methods of analysis, and potential validation plans.

·        Read and understand suggested literature and correlate the data and preparation of the final report.

·        Execute leadership qualities / skills to support an excellent pool of product development scientist

·        Observe safe laboratory practices throughout the laboratory, and maintain good housekeeping in the office area

 

BASIC QUALIFICATIONS

·        PhD in chemistry, pharmaceutical chemistry, pharmaceutics, biochemistry or related field with up to 5 years of experience (preferably in method development, stability evaluation, problem solving etc.,)

·        Experience with HPLC, related spectroscopy and other common analytical methods.

ADDITIONAL QUALIFICATIONS

·        Computer skills must include Microsoft Office Products Suite, e.g., Word, Excel. Computer database skills are desirable.

·        Excellent written and oral communication skills

·        Ability to pay attention to detail, including good documentation skills is required

·        Understanding of cGMP and GLP