stasonpharma.com

Please browse our available career opportunities.

 

 

 

 

 

　

Title: Quality Assurance Associate I

Location: 11 Morgan, Irvine , CA 92618

Scope of Position:

 

The QA Associate I position reports to the QA Manager or designee.  This position’s primary function is to provide support for manufacturing process and product release.  The position will also provide support in the maintenance of the Quality Management System.

 

Responsibilities:

Receive, process, and collect appropriate samples for the release testing of raw materials, in-process materials, and finished products.  Release raw materials, in-process and finished products. Provide support for the manufacturing of all products and projects.  This may include but not limited to:  Room and equipment clearance, QA in-process testing/verification, equipment setup verification, and log sheets verification. Maintain the QA retain room. Assist in the review, modification, training, and filing of documents as part of continuing process improvements. Assist in the review and approval of production related documents. Assist the QA department with the investigation program. Provide QA support for the calibration program. Provide support for the QA documentation system. Perform other duties assigned by department Manager to support the department.

Required Knowledge, Skills and Abilities:

The QA Associate I must have good oral and written communication skills.  Attention to detail is a must.  Adequate computer skills are also required.  Send resume to: qa.hr@stason.com

　

　

Title: RA/QA Associate I

 

Scope of Position:

 

The RA/QA Associate I position reports to the department Manager or designee. This position’s function is to provide support for all activities relating to regulatory compliance including coordination, preparation and review of regulatory submissions. Ancillary functions will also include the audit of data to verify accuracy and completeness and responsibility for the summarization reports. The position will also provide additional support to the Quality Management System.

 

Responsibilities:

Prepare ANDAs, amendments, supplements, annual report, control documents for regulatory submissions.  Evaluate change controls and provide regulatory assessment.  Assist in development, review, and implementation of intradepartmental protocols, reports, SOPs, and other applicable documentations.  Review and summarize adverse drug event data and product quality issues.  Assist in the review, modification, training, and filing of documents as part of continuing process improvements.  Assist the QA department with the investigation program.  Provide QA support for the calibration program.  Provide support for the QA documentation system.  Perform other duties assigned by department Manager to support the department.

Required Knowledge, Skills and Abilities:

BS in a scientific discipline. Strong Microsoft PC skills, including Word, Excel, and familiarity with the internet. Excellent oral and written communication skills. Ability to manage timelines with a project team. Ability to work independent and on teams. Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities. Send resume to: qa.hr@stason.com

　

Analytical Chemist
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: chem.hr@stason.com

Formulator
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: chem.hr@stason.com

Senior Scientist
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: chem.hr@stason.com

Biologist
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.

Career opportunities at our Global R&D Center and Affiliates Links:

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

Research Study Director
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.

Senior Projects Manager
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.

Synthesis Scientist
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:

- LC/MS, LC/MS/MS
- Clinical Sample Analysis
- BA/BE Study, Phase I through Phase III Plasma or Urine Samples
- ADME and PK Studies
- 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
- Drug Metabolites in Biological Media
- Assessment of Test Article Purity and Chemical Characterization
- Analytical Method Development and Validation
- Analysis of Dietary and Botanicals Mixture (Phytomedicines)
- Analysis of Gavage and Infusion Solutions
- Formulation Compatibility Testing and Impurity Profiles
- BioAnalytical and Clinical Sample Analysis