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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


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