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:

Facilities Supervisor/Manager

Saptalis Pharmaceuticals is looking to hire a Facilities Supervisor/Manager to manage our facilities in Hauppauge, NY.

Facilities Supervisor/Manager is responsible for managing GMP pharmaceutical facilities with regards to maintenance of equipment, machinery, utilities, buildings as per current OSHA, FDA regulations, ICH guidelines, cGMPs and Saptalis SOPs. Manage vendor relationships for installation, maintenance, and repair activities. Must have hands-on experience and ability to handle smaller projects utilizing internal resources.

Duties and Responsibilities:
  • Manages the design, planning, construction and maintenance of equipment, machinery, buildings, and other facilities.
  • Performs monitoring of all BMS systems to ensure the facilities, equipment and environmental systems are within specified ranges and operating systems are functioning properly. Observes deviations from systems specifications and works with Facilities staff to correct or resolve these discrepancies. May assist in calibrating and fine‐tuning controls.
  • Manages all aspects of Engineering projects, EH&S, Facility Management.
  • Manages day to day facility management operations including handling of local county, state, federal and other regulatory agencies during facility visits.
  • Should have an understanding of quality systems; Change Control, Deviations, CAPA’s, Audits activities and Computerized Maintenance Management Systems.
  • Possesses a mechanical and electrical acumen including HVAC, Purified Water system, facilities utilities, P&ID’s, schematics and equipment specifications is a must.
  • Works with Operations and Quality Teams in IQ/OQ/PQ of utilities, facilities, processing and packaging equipment.
  • Assists in selection of suitable manufacturing and packaging equipment for commercial scale operations.
  • Responsible for the housekeeping, security, and state of repair of the buildings and grounds.
  • Monitors safety and takes positive steps to eliminate hazardous situations.
  • Coordinates with external vendors and responsible managing preventative maintenance program and calibration of all processing and packaging equipment as per SOPs/schedule.
  • Provides training to mechanics and custodians.
  • Responsible for assuring that all the operations at the plant are in accordance with current OSHA, FDA regulations, ICH guidelines, cGMPs and Saptalis SOPs.
Qualifications:
  • Bachelor’s degree and or a minimum of five years of relevant experience preferred.
  • Strong understanding of Electrical, Plumbing, Carpentry, HVAC systems is required.
  • Thorough understanding of Air Compressors and Water Systems is a must.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use other software such as Project Management etc.
  • Experience working with building management systems preferred.
  • Strong written and oral communication skills required.
  • Knowledge of cGMP regulations and validation principles
  • Ability to work well in a team-oriented environment
  • Ability to multi-task with high efficiency
  • Ability to work well under pressure and maintain efficiency both on an individual and team basis.

Send your resume to info@saptalis.com

Quality Control Group Leader/Supervisor

Saptalis is looking to recruit QC Group Leader/Supervisor immediately to join the Quality Control group at its facility in Hauppauge, NY.

QC Group Leader/Supervisor is responsible for managing chemists daily for testing of in-process, finished product and stability product samples for release. Responsible for meeting the QC timelines to support commercial product supply. In addition, the responsibilities include maintaining analytical laboratory equipment, assisting in investigations and coordinating external testing as needed.

Duties and Responsibilities:
  • Coordinate and direct QC chemists (Finished Product) and daily QC operations to prioritize workload and assure timelines for in-process, release and stability testing are met for commercial products.
  • Assure test reports and other documentation prepared by QC are reviewed and approved for accuracy and data integrity.
  • Supervise/provide guidance daily to analytical chemists during Quality Control release testing of in-process and finished products to assure that drug products manufactured at Saptalis meet all quality attributes essential as per regulatory guidelines.
  • Perform release testing of raw materials for residual solvents as per compendial or approved methods.
  • Perform in-process, finished product/release and stability testing of ANDA/NDA batches and commercial batches as per approved methods.
  • Monitor and assure that test equipment used in the QC laboratory is qualified, maintained, calibrated as per instrument SOPs and data integrity is maintained.
  • Supervise analytical method transfers from R&D or external vendors to QC laboratory for newly validated methods.
  • Provide analytical testing support for process validation batches, cleaning validation program and equipment qualification/calibration studies.
  • Monitor laboratory material control program including labeling and storage of reference standards/reagents/chemicals/solvents and their use.
  • Coordinate proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
  • Review/approve product specifications, analytical methods, method transfer protocols/reports, verification protocols/reports, cleaning validation protocols/reports, PPQ protocols/reports, SOPs and other GMP technical documents.
  • Assist Laboratory Management with OOS, OOT and other Quality investigations to determine root cause for failure results. Implement appropriate root cause corrective actions and preventative actions relating to OOS/OOT investigations and QC activities, as appropriate.
  • Assure that all activities are documented in the assigned laboratory notebooks as per Saptalis procedures and cGLPs.
  • Review analytical laboratory data packages and laboratory notebooks and assure that all testing is performed as per GLP requirements and Saptalis SOPs.
  • Audit the laboratory routinely and assure that the laboratory operates with GMP compliance at all times as per FDA regulations and Saptalis SOPs.
  • Assist Quality Management team during Pre-Approval and general GMP inspections by the USFDA and during internal and external audits. Assist in formulating responses and implementing corrective actions for any observations in laboratory area during these inspections.
  • Train new employees and monitor their job performance in Quality Control department. Assure all personnel in QC are properly trained in respective job functions and with various analytical techniques.
  • Maintain quality performance metrics, conduct routine metrics review, and root cause analysis in collaboration with chemists and laboratory management.
Qualifications:
  • BS/MS/Ph.D. (chemistry or related field) with minimum 4-10 years of proven success in a supervisory/management role QC Laboratory.
  • Must be familiar with GLPs, cGMPs, ICH and USP guidance’s and standards and knowledge of Quality Control Laboratory Instruments.
  • Experience in handling liquid and semi-solid formulations (solutions, suspensions, creams, ointments etc.) is preferable.
  • Must possess strong verbal and written communication skills, interpersonal skills, and the ability to develop strong relationships with team members, co-workers, senior leadership, and regulatory agency representatives.
  • Must have excellent organizational and time management skills, as well the ability to effectively articulate, receive, and analyze information as required.
  • Must demonstrate strong leadership skills, including team accountability, motivation, coaching and development and ability to collaborate with others, perform multiple tasks simultaneously, keep accurate records, and comply with company policies.
  • Ability to work well under pressure and maintain efficiency both on an individual and team basis.
Benefits:
  • 401(k)
  • Health insurance
  • Life insurance
  • Paid time off

Send your resume to info@saptalis.com

Analytical Group Leader

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

Analytical Group Leader 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:
  • Supervise a group of scientists in developing and validating 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.
  • Supervise/perform Out of Specification (OOS) and Out of Trend (OOT) investigations to determine root-cause and implement corrective actions.
  • Manage analytical method transfers from R&D or external vendors to QC Laboratory for newly validated methods.
  • Write/revise analytical methods, method validation protocols, method validation reports, method transfer protocols and reports.
  • Assure that all activities are documented in the appropriate laboratory notebook as per Saptalis procedures and cGLPs.
  • Provide technical support to QC in trouble-shooting on existing analytical methods.
  • Train new employees and organize work schedule for the group to complete assigned tasks.
Qualification:
  • B.S/M.S/Ph.D in Analytical Chemistry or related discipline with 3-8 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.
  • Excellent communication skills, ability to solve technical problems and supervise group of scientists to execute assigned projects in a timely manner.
  • Strong organizational skills, attention to detail, and the ability to work in a team environment

Send your resume to info@saptalis.com

R&D Administrative Assistant

Saptalis is looking to recruit R&D Administrative Assistant immediately to join the company at its facility in Hauppauge, NY.

This individual will assist in all administrative functions of the Company. Responsible for phone systems, copy machines and other office equipment. Will order, stock and maintain chemicals and laboratory supplies in appropriate storage areas, and keep those areas organized and clean. Will assist Document Control manager in compiling documents required for regulatory filings. Will receive visitors and supervise until conclusion of their visit to the plant. Assist the Regulatory Affairs and R&D in preparing protocols, reports, obtaining approval signatures for change controls, training documents etc.

Job Description:
  • R&D Administrative Assistant will receive all visitors to R&D building and monitor their visits and document in the log book regarding the visitor’s time at the plant.
  • Order, stock and maintain office and laboratory supplies.
  • Order, stock and maintain chemicals and other laboratory supplies and organize them in appropriate storage areas. Keep those areas organized and clean.
  • Maintain Laboratory note books and other relevant controlled documents in organized and secure environment.
  • Assist in obtaining approval signatures for change controls, protocols, reports, investigations and training documents such as SOPs, Analytical Methods etc.
  • Assist Regulatory Affairs and Document Control Managers in preparing regulatory documents required for new filings. Assist in photocopying, scanning and organizing the controlled documents including training records for employees.
  • Responsible for obtaining mail and distributing to the corresponding personnel.
  • Adhere to company and regulatory, laboratory and safety policies and SOPs.
  • Document activities accurately and legibly when required.
  • Coordinate with laboratory assistant, custodial personnel, R&D/QC scientists to assure that R&D office and Laboratory areas are clean and safe to operate.
  • Comply with all regulatory/ in-house requirements including but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP and good documentation practices.
  • Assist in preparing test procedures, SOPs and protocols/reports and other GMP documents.
  • Organize work schedule to complete assigned tasks efficiently and on time.
Qualification:
  • A minimum High School graduate degree or equivalent.
  • Good organization and communication skills; and attention-to-detail focus is required.
  • Ability to operate computer with Word and Excel programs.
  • Ability to follow directions and work independently, if necessary.

Send your resume to info@saptalis.com

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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