Immediate Supervisor: IMT Lab Supervisor
Job Type: Part Time
- Assist in daily lab operations
- Schedule experiments
- Ensure adequate inventory and lab supplies
- Prepare and implement quality control procedures
- Assist in the following responsibilities:
- Prepare and analyze tissue samples
- Review data review and prepare reports
- Conduct fundamental instrument maintenance and troubleshooting
- Communicate with clients; and
- Conduct other lab tests related to pharmaceutical/biotech field
- Coordinate with other departments to complete clients’ purchase orders
Degree in microbiology, biology or instrumental analytical chemistry; experience in flow cytometer a plus; good communication, instrument and computer skills.
** Please send resume to: email@example.com.
Location: 11 Morgan, Irvine , CA 92618
- Successful candidate will work within Stason Product Development department for pre-formulation and formulation related projects.
- Responsibilities will include pre-formulation and formulation development for oral solid dosage product; conduct experimental batches of prototype formulations for pilot clinical study and evaluate clinical study results; defining product specifications and perform product transfer for scale up.
- Duties will also consist of process optimization and validation, preparation of technical documents, CMC review, management of multiple development projects and technology transfer projects involving multiple locations.
- Projects include biologic and small molecule projects from synthesis, prototyping, early clinical trials through post-commercialization.
- Track progress and budgets, identify and manage issues, develop creative solutions, and provide management updates.
- MS/PhD in Chemistry, Chemical Engineering or related field required.
- At least 3 years of pharmaceutical industrial experience in pre-formulation and solid dosage formulation development.
- Experiences with HPLC, IC, DSC and UV are preferred.
- Familiarity with FDA regulations, ICH guideline and knowledge of GMP standards and practices.
- Must possess excellent verbal and written skills.
- Ability to interact with cross-functional members and multiple departments to coordinate project completion.
** You can email resume to: firstname.lastname@example.org.
Location: 11 Morgan, Irvine , CA 92618
- Client consultation regarding technical approaches to projects
- Detail Design Specification review and development
- Engineering project management
- Provide technical and administrative support to batches for clinical, submission, and validation purpose.
- Assist sourcing, evaluating and purchasing equipment potentially used in production of solid oral dosage and semi-solid topical products . Coordinate the receiving, qualification/validation activities with QA and maintenance.
- Manufacturing document preparation, process execution, optimization and trouble-shooting.
- Strong verbal and written communication skill
- 0 – 2 years industry experience related to GMP drug manufacture, validation, programming or chemical process design
- A BS or higher degree in chemical engineering, or a related engineering or scientific discipline, or significant related experience
- Strong computer knowledge including Microsoft Office products, AutoCAD or equivalent
Please email resume and cover letter of interests to:
E-mail: email@example.com Fax: 949-380-4345 Web Site: www.Stason.com
Develop testing methods and operate general analytical instruments such as HPLC, GC, UV, IR, AA TLC, and dissolution testing. Perform all necessary calculations associated with the test analyses. Clean, maintain and calibrate laboratory equipment to ensure compliance with cGLP and cGMP. Meet project deadlines and performance standards as assigned. Perform investigations and method validations. Carry out quantitative and qualitative analyses in support of method transfers and cleaning validation. Perform related duties as assigned. Qualifications: Two years related laboratory experience, or an equivalent combination of education and experience. Knowledge of pharmaceutical laboratory testing, analyses and documentation, FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines. Education: MS in Science or related science field. Email resume to: firstname.lastname@example.org
Advanced degrees or substantial experience in chemistry or chemical engineering background. Project management, experience in formulation, process design and optimization of solid or semi-solid oral dosage forms. Strong verbal and written communication skills are a must. Email resume to: email@example.com
Responsibilities include formulation and process design of oral solid or semi-solid products; define specifications; implement clinical batch production, evaluation and interpretation of data, process optimization and validation, preparation of technical reports, and CMC review, resource management multiple development projects and technology transfer projects involving multiple locations. Projects include biologic and small molecule projects from synthesis, prototyping, early clinical trials through post-commercialization. Prepare schedules and budgets identifying milestones and significant tasks, such as process and assay development, process scale-up and transfer, assay transfer, raw material & placebo procurement, production for clinical trials, test & process validation batches, stability data, etc. Align and facilitate teams to ensure milestones and tasks are met. Interact with cross-functional members and other departments to implement the project. Track progress and budgets, identify and manage issues, develop creative solutions, and provide management updates. Qualifications: MS or PhD in pharmaceutical field is preferred. Familiar with FDA regulations; GMP knowledge. Experience in granulation, coating, tablet compression and encapsulation. Verbal and writing skills; interactions with supportive departments and affiliates. Email resume to: firstname.lastname@example.org
Prepare and analyze tissue samples; operate cytometer; prepare reports; perform fundamental instrument maintenance and troubleshooting; log in and update experiment schedule; communicate with hospitals and universities; and conduct other lab testing procedures related to pharmaceutical/biotech field. Degree in microbiology, biology or instrumental analytical chemistry; experience in flow cytometer a plus; good communication, instrument and computer skills.
Senior Research Scientist
Develop and document validated analytical methods in bioanalytical and pharmaceutical analysis. Plan and execute technical programs. Experience working with LC/MS/MS solid phase and liquid-liquid extraction and HPLC, project management, method development and discovery R & D. Ph.D. in chemistry. Courses in analytical chemistry, separations, trace analysis, and mass spectrometry
Implement nonclinical laboratory studies, develop laboratory procedures, interpret and analyze data, write and edit reports; managing skills. Strong verbal and writing skills, and leadership qualities. Ph.D. with toxicology experience or in a related science, or directly applicable experience.
Coordinate project design, implementation, progress monitoring among multiple divisions, departments, subsidiaries and affiliates; willing to travel overseas and accommodate occasional long-term overseas stays; substantial experience in organizing pharmaceutical and biotech projects from the discovery stage to IND/NDA status, including NME development, API synthesis, pre-formulation studies, process design, analytical testing requirements, and design of clinical protocols.
Develop API synthetic routes, scale-up, control measures at lab scale to commercial scale. Perform synthesis, purification and characterization organic compounds using contemporary methods or fermentation methods. Knowledge in analytical methods common to organic synthesis (i.e. NMR, MS, IR). Experience with vinyl polymerization and suspension polymerization. MS/Ph.D. in Organic Chemistry or Polymer Science with prior production synthesis experience. 3-5 years bench work experience working in an industrial laboratory setting, ideally those regulated under FDA guidelines.
Consultants, Scientific Advisors
Those with extensive experience in the pharmaceutical industry but unable to commit themselves to full-time positions are welcome to join us as consultants for the following fields:
a.. LC/MS, LC/MS/MS
b.. Clinical Sample Analysis
a.. BA/BE Study, Phase I through Phase III Plasma or Urine Samples
b.. ADME and PK Studies
a.. Accelerated ADME and PK Projects in support of drug discovery, including microsomal P450 enzyme system, drug stability evaluation, enzyme induction / inhibition analysis, and hepatocyte incubation
c.. Drug Metabolites in Biological Media
d.. Assessment of Test Article Purity and Chemical Characterization
e.. Analytical Method Development and Validation
f.. Analysis of Dietary and Botanicals Mixture (Phytomedicines)
g.. Analysis of Gavage and Infusion Solutions
h.. Formulation Compatibility Testing and Impurity Profiles
i.. BioAnalytical and Clinical Sample Analysis