Process Development Associate
Kelly Scientific Resources (KSR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Since its launch in 1995, KSR has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. Today, KSR leads the world in dedicated scientific and clinical research staffing. Visit http://www.kellyscientific.com / to learn more and view a full listing of our opportunities.
Process Development Associate - Pharma
Product Launch is responsible for preparation of the new product for launch under Technical Operations scope of activities. These activities include documentation, manufacturing of Process Validation, Launch, Site Transfer and stability batches, and any required process optimization, investigation and/or production troubleshooting. Process support works closely with external groups such as Formulation Development, Regulatory Affairs, Quality and Operations to provide seamless transition of the new products from Development to Commercial Operations.
Job Summary:
Responsible for the supervision of and providing assistance with new product launch projects during the optimization trials, manufacturing of process validation and launch batches to ensure the manufacture of high quality products, and the use of efficient manufacturing processes.
Key Job Responsibilities
- Investigates formulation and process deficiencies for new products and/currently manufactured in order to determine the causes and to recommend solutions for improvement.
- Executes and provides technical support to experimental trials in order to evaluate required changes to optimize formulations and manufacturing processes.
- Monitors and supervises full-scale manufacture of products, as required, to provide technical support and /or technology transfer to the manufacturing departments.
- Writes investigational reports, project summaries, project updates, and provides recommendations, as required.
Technology/Instrumentation
- Able to interpret in-process and analytical data and provide recommendations for process improvements as required.
Experimental or Methodological Design
- Designs, executes and evaluates trials to develop robust manufacturing processes.
- Executes trials to test the robustness of the formulas and manufacturing processes.
Relationship with Internal/External Customers Stakeholders
- Responsible for the preparation of documentation and obtains the necessary approvals to support Change Control Forms to change the Masters, SAP Recipes and Certificates of Analysis.
- Responsible for Investigation and root cause determination of Quality Notifications and review of draft Master Formulae issued for Technical Operation.
Problem Solving Analysis
- Responsible and accountable for troubleshooting and resolving challenges during the manufacture of pharmaceutical solid dosage forms.
Decision Making/Autonomy
- Applies strong analytical / problem solving skills and utilizes all available resources to correctly identify process and / or formulation deficiencies and proactive in implementing a solution.
- Responsible and accountable for decisions made to eliminate process related problems in Production.
Leadership/Professional Development of Self Others
- Attends appropriate training, seminars and presentations to maintain expertise in formulation development, manufacturing equipment and processes, raw materials, pharmaceutical technologies, and related areas.
Job Requirements/Education/Competencies:
- College/University degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering or related science.
- Minimum of 2+ Years working experience in the pharmaceutical industry with related experience in solid dosage forms development, scale up and/or technology transfer.
- Extensive knowledge and experience in pharmaceutical processes and equipment
- Strong verbal and written English communication skills
- Excellent organization, troubleshooting and reports writing skills.
- Intermediate to Advanced level of computer skills in Microsoft Office (Word, Excel, PowerPoint and Outlook)
- Multi-tasking and project management skills
- Capable of issuing and investigation of Quality Notifications and CCFs in SAP (Master Formulae, SAP Recipes and Certificate of Analyses)
- Thorough understanding and knowledge of cGMPs, GLP, SODs, SWPs, USP, BP, EP SUPAC, FDA and HPFBI guidelines.