Catalent Pharma Solutions Formulation Scientist in St Petersburg, Florida
I. Department Overview: (A brief summary describing the function of the department)
Product Development is responsible for new product development over the lifecycle of the project which could include benchtop/labscale, demonstration/feasibility batches, registration/stability batches, and technical support of process validation batches. Addition responsibilities may include support of development/commercial product investigations, and technology transfers from other sites to the St. Petersburg, FL facility. The group is also responsible for Gap Assessments, Risk Assessments, and the implementation of quality by design (QbD), process analytical technology (PAT) solutions and overall support of all aspects of product development.
II. Basic Function: (A brief statement describing the basic purpose of the job) This position contributes significantly to the successful timely development of new pharmaceutical products utilizing Softgel Formulation/Process drug delivery systems and technologies by carryingout required formulation and process development activities.
III. Specific Activities, and Responsibilities: (A concise list of the key responsibilities of the job) · Executes experimental studies intended to provide supporting data or to resolve technical issues encountered during each project. Defines technical objectives and conveys them to other members of the project team. · May represent the Softgel Product Development department at both internal team meetings and customer meetings relating to assigned projects that may be of diverse scope (including other technologies) · Coordinates with Analytical Services, Operations, QC, QA, and other groups to ensure project requirements are met. · Resolves technical issues, makes recommendations for options that would resolve the issue, including a preferred option. · Works independently, and recognizes key issues likely to affect successful and/or timely completion. For those issues that cannot be resolved, brings them to the attention of the person coordinating the work. · Schedules work in order to ensure timely completion of the required activities. · Proposes and implements recommendations to processes and procedures designed to increase efficiency, safety or quality. · Understands revenue associated with each project phase. Flexible with respect to project priorities and ensures that site and/or departmental business objectives are met. · Completes technical activities, development reports and regulatory support documentation as required. · Maintains awareness of current scientific practices that may have a relevance to Catalent Pharma Solutions. · When requested, provides other support as required. · Complies with Health, Safety and Environmental responsibilities for the position.
· Maintains current training records for required procedures. · Assists in the training, development, and evaluation of any Softgel Formulation personnel when required.
· Complies with departmental and company policies.
IV. Knowledge Requirements:
Education or Equivalent:**(Minimum required to perform job) · PhD in Pharmacy/Pharmaceutical Sciences, Engineering, or related science with 1-3 years of applicable product development experience required, and direct softgel product development experience preferred. · MS/BS in Pharmacy/Pharmaceutical Sciences, Engineering, or related science with 3 years of applicable product development experience and direct softgel product development experience preferred. · Knowledge Skills: Working knowledge and application of scientific principles and techniques. Exposure to computer software associated with word processing and spreadsheets required with exposure to statistical software preferred. · Supervises: None.
Knowledge/Skills Requirements:(Unique knowledge skills, or problem-solving requirements.)** · Familiarity with batch processing in a pharmaceutical, cGMP environment
· Strong knowledge of cGMP Regulatory requirements for process development, technical transfer, and process changes required
· Familiarity with ISPE and ICH guidelines preferred
· Design, plan, and execute experiments based upon scientific methods for problem solving and process development purposes preferred
· Effective communication, documentation and writing skills required
· Basic to advanced statistical analysis and calculations preferred
· Attention to detail and high-level of organizational skills required
· Basic project management skills (deliverables, timelines, resources required) is preferred
· Basic to advanced encapsulation/softgel manufacturing troubleshooting skills required
· Knowledge of equipment and tooling selection and design based on process and cleaning requirements required
· Familiarity with cleaning cycle development and design including evaluation of detergents, test methods, and calculation of residual limits preferred
· Familiarity with root cause analysis and risk assessment techniques (e.g. FMEA) preferred
Physical/Mental Requirements:(List any special requirements to be able to perform job)* · Mathematical and reasoning ability* · Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form · Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-20 pounds. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently**
Individual’s primary work areas will be the office, manufacturing, and laboratory areas. Office and Lab area typically have low noise levels; the manufacturing floor typically has a low to moderate noise level.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Job Research & Development
Organization: Softgel Technologies
Title: Formulation Scientist
Location: FL-St Petersburg
Requisition ID: 0020394