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发帖数: 994 | 1 Don't send email to me. Please contact Lana Levy at l***[email protected]
Job Title: Formulation Scientist
Location: St. Petersburg, FL
Job Description:
Our client is a leading Drug Development, Advanced Delivery Technology and
Supply partner to the global pharmaceutical industry. A Fortune 1000 company
, with over 20 locations on 5 continents, we partner with 90 out of the top
100 pharmaceutical companies and 44 of the top 50 biotech firms, as well as
thousands of small innovator companies.
I. Department Overview:
Softgel Formulation R&D is responsible for the following:
Development and evaluation of softgel capsule fill formulations
Development and manufacture of softgel capsule prototypes
Transfer of new products into the site
Scale up into the production area and clinical batch manufacturing support.
II. Basic Function:
Provides support to proactive and fee for service development projects for
the following:
Development of fill formulations gelatin-based softgels and capsules
Selection of shell formulations and/or development of new shell
formulations for gelatin-based softgels and capsules
Development of color formulations for gelatin-based softgels and capsules
III. Specific Activities, and Responsibilities:
Evaluate, source, and order raw materials for formulation development
efforts
Develop formulations for the delivery of APIs in the softgel dosage form
which includes but is not limited to the following activities:
Excipient selection
Solubility & miscibility screening
Fill rheology evaluation
Dispersion evaluations
Development of lead and backup formulations
Temperature cycling
Water Uptake Evaluation
Determination of critical process parameters for mixing and encapsulation
Conduct feasibility and robustness screening of customer-supplied fill
formulations
Conduct encapsulation trials for initial proof-of-concept, stability
evaluations
Work with process engineering staff in the scale up of formulations from
the benchtop
Work with Project Management in supporting Proactive and FFS projects in
the development of scopes of work, timelines, and budgets
Determine and acquire necessary equipment and/or equipment modifications to
meet project requirements.
Perform and/or participate in DOE studies to optimize processes.
Writing batch paperwork, test protocols, and reports.
Conducting literature and patent searches.
Staging and monitoring of experiments.
Keeping accurate and detailed records of experiments including results and
conclusions.
Provide reports and updates of projects and activities as requested.
Comply with Health, Safety and Environmental responsibilities for the
position.
Other tasks as assigned.
Work with minimal supervision
IV. Knowledge Requirements:
Education or Equivalent:
Ph.D. in Pharmaceutics, Biochemistry, Chemical Engineering or related
science with 1-3 years of experience in
Pharmaceuticals, or
M.Sc. in Pharmaceutics, Biochemistry, Chemical Engineering or related
science with 3-5 years of experience in
Pharmaceuticals, or
B.Sc. in Pharmaceutics, Biochemistry, Chemical Engineering or related
science with 5-8 years of experience in
Pharmaceuticals
Knowledge/Skills Requirements: (Unique knowledge skills or problem-solving
requirements.)
3-5 years of pharmaceutical formulations, laboratory experience and
manufacturing a plus;
Minimum of 1 year of experience in the formulation of solution, suspension
and semisolid formulations required
1 year of experience with oral lipid based formulations, self micro-
emulsifying delivery systems (SMEDS) and enhanced solubility systems (ESS)
preferred
Experience in cGMP/cGLP environment preferred
Hands on experience with HPLC and/or UPLC preferred
Hands on experience with benchtop formulation development required
Understanding of ICH, FDA, EMEA, and ANVISA guidelines and regulations
Familiarity with potent compound containment engineering controls such as
flexible containment systems, isolators, and downflow booths
Proficient user of MS Office
Familiarity with Statistical Software such as SAS JMP or Minitab preferred
Familiarity with DOE and statistical techniques preferred
Excellent verbal and written communication skills required.
Additional languages a plus: German, French, Italian, Spanish, Japanese
Physical/Mental Requirements:
Ability to work effectively under pressure to meet deadlines.
Individual may be required to sit, stand, walk regularly and occasionally
lift 0-20 pounds.
Individual will be required to work with highly potent compounds (including
hormones and cytotoxic compounds) which will require use of PPE such as
respirators and PAPR
Be accessible to manufacturing, laboratory and office staff.
Be able to use required office equipment.
Vision requirements include reading of written documents, frequent use of a
computer monitor, evaluation of samples via microscopy.
Ability to work extended hours or off-hours as required.
Work Environment:
Individual's primary workstation is located in the lab, where the noise
level is low.
Work in the production areas and in the pilot labs will also be
periodically required. |
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