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Associate Director, Product Development

Lipocine, Inc.


Location:
Salt Lake City, Utah 84108
Date:
05/02/2017
2017-05-022017-07-01
Job Type:
Employee
Job Status:
Full Time
Lipocine, Inc.
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Job Details

JOB SUMMARY

Plans, coordinates and manages all formulation and process development, clinical supplies manufacturing, scale-up and technology transfer to partners and/or contract manufacturer, including validation for drug products.  Performs job functions in accordance with the Occupational Safety and Health Administration (OSHA) guidelines and in compliance with the Standard Operating Procedures (SOP), the Food and Drug Administration (FDA) regulations, Standard Test Methods (STM) and Current Good Manufacturing Practices (Ccmp).

 

ESSENTIAL FUNCTIONS

1.   Responsible for all formulation, process development and scale-up activities, clinical supplies manufacture, and product/process transfer to partners/contract manufacturers, including validation activities for all projects.

2.   Sources excipients and API for product formulation.

3.   Interacts with contract manufacturers/partners on issues related to scale-up, validation and commercial product manufacture.

4.   Responsible for preparing quality CMC documentation to support all regulatory filings.

5.   Proposes and manages all process/product improvements and alternate vendor changes for products in development.

6.   Works closely with all departments to coordinate selection, technology development and patent filings/prosecution.

7.   Leads efforts on new product candidate selection, technology development and patent filings/prosecution.

8.   Responsible for managing/supervising a team of 2-5 scientists including Ph.Ds.

9.   Develops an annual Expense and Capital Budget.  Operates within budget constraints.

ADDITIONAL RESPONSIBILITIES

1.   Performs other duties assigned by Management.

2.   Acts as Controlled Substance Officer.

 

Requirements

QUALIFICATIONS (EDUCATION/EXPERIENCE REQUIREMENTS)

Ph.D. in Pharmaceutics or related discipline required.  5-10 years of experience in the pharmaceutical product formulation and development of oral drug products and supervisory/managerial experience required.  Formulation/process product development experience in lipid based, solid oral formulations and gelatin capsule products preferred.  Experience/expertise in identification/selection of new development candidates, technology development, patent filing/prosecutions, particularly preferred.

PHYSICAL OR MENTAL CRITERIA

Leadership skills

Requires maturity and experience to interface with all levels of management & employees.

Effective managerial, communication, negotiation, and problem solving skills.

Ability to reflect a positive attitude.

Team work skills

Organizational skills.

RELATIONSHIPS AND CONTACTS

Direct Reports and Senior Management

Partners, Consultants, Contract Manufacturers, Equipment Manufacturers and API/Excipient suppliers  

Heads of Clinical R&D, Regulatory Affairs and Analytical R&D

FDA interactions on CMC issues

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