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Process Development Director

Job Title: Process Development Director
Contract Type: Permanent
Location: Unknown
Industry:
REF: 122542
Contact Name: Gerry Kennedy
Contact Email: gerry@rftgroup.ie
Job Published: almost 2 years ago

Job Description

Director of Process Development?.Grand Bahamas

Partnered with a world leader player in the pharmaceutical industry, our client is a fine chemical contract manufacturer producing high quality bulk API, at its production facility in Freeport, Grand Bahama.
The company is in the process of developing a major expansion of its state of the art 62 acre facility, and seeks to appoint a highly experienced Process Development Director for this permanent based tax free appointment.


Specific Responsibilities and skills for Position

Lead and coordinate chemistry project teams, identify process improvements, devise novel solutions and strategies to complex synthetic problems and implement in the lab and Production Plant; deliver high quality API requirements on time, prepare timely documentation (batch records, reports, development reports, etc), and provide technical, problem solving, and scientific leadership. Preparation of documents for regulatory submission (e.g. IND filing / update, NDA filing etc.)


Proven track record of significant accomplishment in Process Development (API production, GMP compliance, problem solving, novel idea generation and implementation, multi-step synthesis of complex molecular architecture, outstanding oral and written communication skills).

Essential Duties and Job Functions

Develop chemical processes for manufacturing drug substances
- Lead projects related to delivery of Active Pharmaceutical Ingredient (API) or Drug Substance to support clinical studies and commercial needs
- Help advance the development of economical and state-of-the-art techniques to isolate, characterize, purify, and mass-produce substances
- Plan, design, implement, and analyze laboratory experiments to advance scientific knowledge of drug substances or drug products
- Provide direction to members of project teams on initiation and execution of laboratory experimentation, while considering economic, regulatory, and safety factors
- Use ingenuity and creativity when working on complex problems, where analysis of a situation or data requires evaluation of intangible variables
- Maintain in-depth knowledge of principles and theories and apply that knowledge to support company interests


- Demonstrate technical proficiency, employ scientific creativity, think independently, and collaborate with others when suggesting experimental design and research strategies
- Work independently, creatively, and think critically to determine appropriate resources for resolution of problems

Person Spec :


- 12 years or more experience with PhD in a relevant scientific discipline, or extensive industry experience with MS/BS degree
- Thorough understanding of API production in a current Good Manufacturing Practice (cGMP) environment, cGMP compliance, novel route generation, and implementation
- Able to collaborate with others efficiently and effectively
- Excellent scientific communication (verbal and written), organizational, planning, problem-solving, and critical thinking skills

Cv to gerry@rftgroup.ie 01 2302400 www.rftgroup.ie