Director of Process Chemistry

 

Location:  Southern California

Industry: Pharma Chemistry, API Services

 

Our client is a privately held California-based company with over four decades experience providing contract Active Pharmaceutical Ingredient (API) development and manufacturing services. This includes Process Development, Analytical Services, and cGMP Manufacture of API’s and their intermediates as well as particular expertise in the production of Controlled Substances and Potent Compounds. They provide certified regulatory-compliant services in their modern FDA and DEA approved laboratories and facilities. They perform preclinical and cGMP manufacturing from small laboratory scale through Large Scale Lab and Kilo Lab up to 200 gallon reaction scale and tailor API development services to meet client needs.

 

Position Summary:

Responsible for providing strategic and operational direction for Chemical Development and Chemical Process Research company-wide. The Director, Synthetic Chemistry will lead internal project groups and is responsible for (i) leading productive experimental programs, (ii) effectively communicating results and issues within the projects and management and client organizations, (iii) initiating and leading proprietary research activities within the organization, (iv) ensuring positive company client customer relations and (v) developing and supporting business development activities.

 

Responsibilities:

  • Maximize capacity and develop the capabilities of the synthetic chemistry group
    • Recruit highly capable chemists at appropriate levels to complement the existing synthesis staff
    • Develop the knowledge and skills of all staff to create a technical team capable of excelling on the types of projects presented to the Company.
    • Provide leadership/management within the department through a structured process of objective setting, performance appraisal, and individual development.
  • Lead an active laboratory program, developing new routes of synthesis, modification of reactants and/or equipment, and synthesis of target molecules
    • Solve complex chemical, material processing and environmental problems which arise
    • Utilize modern and classical organic chemistry

·        Manage multiple projects concurrently and ensure that client projects are completed in a timely, effective, and high quality manner

    • Provide technical leadership so that projects are efficiently executed and customer expectations are met or exceeded whenever possible
    • Develop and implement systems for project management
    • Work with Business Development on the preparation of customer proposals for potential future projects
    • Develop and implement systems for customer communications
  • Optimize the chemical pathways for preparing active pharmaceutical ingredients
    • Compare availability and costs of raw materials
    • Assess equipment requirements, patent limitations, and industrial hygiene concerns
    • Increase reproducibility of product quality and yields
    • Ensure compliance with government regulations
  • Ensure that all GMP projects are carried out under guidelines as promulgated under CFR Title 21
    • Oversee the adaptation of laboratory or third party supplied procedures to GMP operations
    • Assist in the setting of specifications for raw materials and intermediates
    • Make sure that all Batch Records are clear and concise
    • Follow GMP protocols and procedures for execution of GMP projects
    • Interact constructively with Quality Assurance and Quality Control
    • Write SOPs; write and perform IQ/OQ’s as needed
  • Work with Business Development to increase the number and quality of business opportunities
    • Develop a strong technical reputation for the synthesis group
    • Make sure that this reputation is as widely-known as possible, especially with current customers and future customer prospects
    • Help identify new customer prospects
    • Help convert new customer prospects to customers
  • Work with other leaders in the company to identify business opportunities that offer the greatest promise for revenue and profit growth
    • Create business plans for new business opportunities
    • Identify and help manage investments in facilities and equipment to support new and existing businesses
  • Act as an internal consultant for other leaders within the Company

 

Requirements:

  • A PhD degree in chemistry or chemical engineering with at least 7 years of industrial experience, preferably in a contract research or custom synthesis environment
  • Demonstrated technical competence in the area of process research demonstrated through publications, patents, or other awards & accomplishments
  • A record of effective leadership with outstanding results by creating a positive work environment with emphasis on teamwork and collaboration
  • Experience interacting directly with customers, preferably including communications before, during and after the execution of projects
  • Preferred experience with the following activities:
    • Formal assessment of employee performance, including decisions regarding compensation, promotions and terminations
    • Identification of and recruitment of new employees
    • Identification of and recruitment of new customers
    • Development of plans for and supervision of facility expansions and equipment acquisitions