Careers @ Saptalis

Join Our Team

People are the heart of our company, and we’re committed to fostering their success. We are looking for people with positive attitude and who are dedicated and can make an impact. If you are interested in learning more about a career at Saptalis Pharmaceuticals, please submit your resume directly to info@saptalis.com.

We are actively looking to fill the following positions:

Document Control Assistant

Saptalis is looking to recruit Document Control Assistant to join the Document Control Group at our facility in Hauppauge, NY.

Document Control Assistant is responsible for assisting in managing GMP documentation preparation, distribution and archival. Individual should have good computer skills with Microsoft office Word, Excel etc.

Job Description:
  • Assist in the distribution, reconciliation, labeling and filing of GMP documentation.
  • Update and maintain document tracking databases and archival systems.
  • Update and maintain document tracking databases and archival systems.
  • Distribute approved documentation to appropriate personnel, track receipt of documentation, reconciliation and maintain distribution matrices.
  • Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties, monitors document status and approval notifications, distributions and archiving.
Qualification:
  • BA/BS degree or Associate degree or High school diploma or GED with equivalent experience is preferred.
  • 0 to 2 years of relevant experience in the pharmaceutical/biopharmaceutical industry is preferable.
  • This position requires a good knowledge of computer applications in the Microsoft Office Suite; including scanning of documentation.
  • Some physical movement of document files/boxes is required; must be able to lift 30 pounds.
  • Must exhibit a positive/professional attitude, ability to work independently as well as in team environment.
  • Ability to perform work accurately and thoroughly with great attention to detail.

Send your resume to info@saptalis.com

Analytical Scientist

Saptalis is looking to recruit Analytical Scientists to join the growing Analytical R&D group at our facility in Hauppauge, NY.

Analytical Scientist is responsible for developing and validating analytical methods for analytes of interest in new drug products using UPLC, HPLC, GC and other analytical instruments. Execute all functions in accordance with current FDA regulations, ICH guide lines, USP methodologies, cGLPs and Saptalis SOPs.

Job Description:
  • Develop analytical methods to quantify amount of drug, impurities/degradants, preservatives, anti-oxidants, residual solvents or any other analyte of interest in finished dosage forms.
  • Perform validation/verification experiments for raw materials and finished dosage forms as per approved method validation protocols, Saptalis SOPs and ICH guidelines.
  • Perform in-process, finished product/release and stability testing of new dosage forms as per the approved methods.
  • Perform analytical method transfer from R&D to QC Laboratory for newly validated methods.
  • Write/revise analytical methods, method validation protocols, method validation reports, method transfer protocols and reports.
Qualification:
  • B.S/M.S/Ph.D in Analytical Chemistry or related discipline with 0-2 years of laboratory experience in pharmaceutical analysis.
  • Hands-on instrumentation experience using analytical techniques such as UPLC, HPLC, GC, UV, Dissolution, IR, FTIR etc. Sound knowledge of separation and spectroscopic sciences.
  • Experience in handling liquid and semi-solid formulations (solutions, suspensions, creams, ointments etc.) is preferable.
  • Good communication skills and ability to collaborate with others, ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
  • Ability to work independently as well as in team environment.

Send your resume to info@saptalis.com

Quality Control Scientist

Saptalis is looking to recruit QC Scientists to join the growing Quality group at our facility in Hauppauge, NY.

QC Scientist is responsible for GMP testing of raw materials, in-process, finished product and stability samples for release. In addition, the responsibilities include maintaining laboratory equipment, assisting in investigations and coordinating external testing as needed.

Job Description:
  • Conduct Analysis in compliance with cGMP requirements, compendia standards, and Saptalis SOPs.
  • Maintain accurate record of analysis and perform documentation to company standards.
  • Prepare test solutions, volumetric solutions, and samples used in analysis.
  • Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished, and stability products analysis as per approved methods and regulatory requirements.
  • Use a variety of analytical instruments such as HPLC, GC, UV Spectrophotometer, FTIR, Dissolution apparatus, Particle size analyzer, Auto Titrator, Karl Fisher (KF), Potentiometer etc.
Qualification:
  • BS/MS Degree (chemistry or related field) with 0-2 years of experience in Analytical Laboratory. A combination of equivalent education and relevant work experience may also meet these requirements.
  • Knowledge of cGxP, FDA and GMP regulations, Quality Control Laboratory Instruments.
  • Experience in handling liquid and semi-solid formulations (solutions, suspensions, creams, ointments etc.) is preferable.
  • Good communication skills and ability to collaborate with others, ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
  • Ability to work independently as well as in team environment.
  • Must be flexible with changing business needs and perform duties as assigned.

Send your resume to info@saptalis.com

Validation Associate

Saptalis is looking to recruit a Validation Associate to join a growing Technical Operations group at our facility in Hauppauge, NY.

Validation Associate is responsible for execution of qualification and validation programs for processing and testing equipment, computer systems, manufacturing processes and cleaning of manufacturing equipment as per FDA regulations and SOPs.

Job Description:
  • Supports the process validation programs associated with manufacturing process, equipment qualification, computer validation and cleaning validation studies.
  • Assist in developing qualification and/or validation plans including drafting protocols, and reports. Modify SOPs as necessary.
  • Assist Vice President of Engineering for data collection during Facility Qualification, Manufacturing and Packaging Equipment Qualification process.
  • Coordinate collection of required samples during Process Performance Qualification studies. Coordinate with Analytical R&D/QC to obtain necessary data as per Protocol.
  • Assess analytical data for thoroughness, accuracy, and compliance. Evaluate the robustness of manufacturing processes using statistical evaluation.
Qualification:
  • Bachelor’s degree required, preferably in a science or engineering related field.
  • 0-2 years of validation experience in pharmaceutical, food & beverage, chemical manufacturing or cosmetics industry experience is preferred.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use statistics software.
  • Knowledge of cGMP regulations and validation principles.
  • Ability to work well in a team-oriented environment.
  • Well-developed communication and technical writing skills.

Send your resume to info@saptalis.com

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