Address
Form of work Description/Comment: Duration: 6 months w/ possible extension
Must have good people management experience. This role will be leading the Product Development team, overseeing the lab technicians and associate scientist. Must have experience with equipment calibration and lab requirements experience. Please pay close attention to the years of experience in the job description.
"I. Department / Position Overview:
Product Development is responsible for new Product Development over the lifecycle of the
project which could include benchtop/lab scale, demonstration/feasibility batches,
registration/stability batches, and technical support of process validation batches. Additional
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 process analytical
technology (PAT) solutions and overall support of all aspects of Product Development.
II. Basic Function:
This position contributes significantly to the successful timely development of new pharmaceutical
products utilizing Softgel Formulation/Process drug delivery systems and technologies by carrying
out required pre-formulation, formulation and process activities.
III. Knowledge Requirements:
Responsible for scheduling and/or conducting the pre-formulation, formulation preparation,
testing and analysis work in the PD lab including but not limited to the following timely
completion of the required activities:
Supervise a team of Lab Technicians, manage Lab Technician's schedule and provide hands
on support for the team. Team's responsibility including but not limited to:
Perform solubility and compatibility studies.
Prepare laboratory fill mixes, air fill capsules.
Prepare gel swatches.
Execute drying studies.
Perform fill moisture, water activity, hardness, rheology, burst strength,
impact/drop testing, disintegration, dissolution and/or other testing.
Perform HPLC analysis. Prepare buffers, mobile phase and dissolution media.
Provide experimental details and record the results in approved notebooks, batch
records, reports and logbooks.
Prepare samples for animal PK studies.
Organize experimental product storage in appropriate storage space
Maintain calibration schedule and request PM for the laboratory instruments.
Maintain raw materials inventory used for formulation development activities.
Maintain lab consumables inventory.
Maintain safety, cleanliness, and compliance for Laboratory
Provide training to new or existing personnel.
Required to read and execute departmental guidance and SOPs.
Comply with Health, Safety and Environmental responsibilities for the position and be
responsible for the overall compliance and organization of the laboratory
Maintain current training records for required procedures.
Perform other miscellaneous duties as required.
May be required to work with highly potent compounds, hormones.
Maintain cleanliness and compliance for Laboratory, and inventory of experimental products
Familiarity of Waters Empower
Education or Equivalent: Hours: 8:00am to 5:00pm Location: 101 2725 Scherer Drive North 13-4268760 St. Petersburg FL 33716 United States Education: Additional Job Details: JD - PD Lab Supervisor Ph.D. in Pharmacy/Pharmaceutical Sciences, Chemistry, or related science with 5 years of applicable Product Development experience (3 years in GMP environment) required OR MS in Pharmacy/Pharmaceutical Sciences, Chemistry, or related science with 8 years of applicable Product Development experience (5 years in GMP environment) required OR BS in Pharmacy/Pharmaceutical Sciences, Chemistry, or related science with 10 years of applicable Product Development experience (8 years in GMP environment) required. 1-3 years of people management experience is strongly preferred Prior experience working in the pharmaceutical industry, particularly in a laboratory setting is preferred. Must possess good interpersonal skills. Ability to effectively communicate with co-workers. Good organizational skills required. Good laboratory and analytical skills required. Knowledge/Skills Requirements: Must have accurate and legible documentation skills.
Must have good people management experience. This role will be leading the Product Development team, overseeing the lab technicians and associate scientist. Must have experience with equipment calibration and lab requirements experience. Please pay close attention to the years of experience in the job description.
"I. Department / Position Overview:
Product Development is responsible for new Product Development over the lifecycle of the
project which could include benchtop/lab scale, demonstration/feasibility batches,
registration/stability batches, and technical support of process validation batches. Additional
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 process analytical
technology (PAT) solutions and overall support of all aspects of Product Development.
II. Basic Function:
This position contributes significantly to the successful timely development of new pharmaceutical
products utilizing Softgel Formulation/Process drug delivery systems and technologies by carrying
out required pre-formulation, formulation and process activities.
III. Knowledge Requirements:
Responsible for scheduling and/or conducting the pre-formulation, formulation preparation,
testing and analysis work in the PD lab including but not limited to the following timely
completion of the required activities:
Supervise a team of Lab Technicians, manage Lab Technician's schedule and provide hands
on support for the team. Team's responsibility including but not limited to:
Perform solubility and compatibility studies.
Prepare laboratory fill mixes, air fill capsules.
Prepare gel swatches.
Execute drying studies.
Perform fill moisture, water activity, hardness, rheology, burst strength,
impact/drop testing, disintegration, dissolution and/or other testing.
Perform HPLC analysis. Prepare buffers, mobile phase and dissolution media.
Provide experimental details and record the results in approved notebooks, batch
records, reports and logbooks.
Prepare samples for animal PK studies.
Organize experimental product storage in appropriate storage space
Maintain calibration schedule and request PM for the laboratory instruments.
Maintain raw materials inventory used for formulation development activities.
Maintain lab consumables inventory.
Maintain safety, cleanliness, and compliance for Laboratory
Provide training to new or existing personnel.
Required to read and execute departmental guidance and SOPs.
Comply with Health, Safety and Environmental responsibilities for the position and be
responsible for the overall compliance and organization of the laboratory
Maintain current training records for required procedures.
Perform other miscellaneous duties as required.
May be required to work with highly potent compounds, hormones.
Maintain cleanliness and compliance for Laboratory, and inventory of experimental products
Familiarity of Waters Empower
Education or Equivalent: Hours: 8:00am to 5:00pm Location: 101 2725 Scherer Drive North 13-4268760 St. Petersburg FL 33716 United States Education: Additional Job Details: JD - PD Lab Supervisor Ph.D. in Pharmacy/Pharmaceutical Sciences, Chemistry, or related science with 5 years of applicable Product Development experience (3 years in GMP environment) required OR MS in Pharmacy/Pharmaceutical Sciences, Chemistry, or related science with 8 years of applicable Product Development experience (5 years in GMP environment) required OR BS in Pharmacy/Pharmaceutical Sciences, Chemistry, or related science with 10 years of applicable Product Development experience (8 years in GMP environment) required. 1-3 years of people management experience is strongly preferred Prior experience working in the pharmaceutical industry, particularly in a laboratory setting is preferred. Must possess good interpersonal skills. Ability to effectively communicate with co-workers. Good organizational skills required. Good laboratory and analytical skills required. Knowledge/Skills Requirements: Must have accurate and legible documentation skills.
