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:

Regulatory Affairs Associate

Saptalis is looking to recruit a Regulatory Affairs Associate to join our team at our facility in Hauppauge, NY.

Regulatory Affairs Associate is responsible for preparation of all sections of regulatory filings. Strong understanding of computer software is required. Individual should have thorough understanding of regulatory requirements for pharmaceutical product development for the US market. Person should have excellent team work ethic and good written and verbal communication skills are required.

Job Description:
  • Assist in preparation and review of CMC sections of ANDAs/NDAs for technical accuracy and regulatory compliance.
  • Write/review method validation protocols, reports, methods and validation data packages for actives, impurities/degradants, preservatives etc.,
  • Assist in preparation and review of technical documents such as batch records, packaging records, product and component specifications etc.
  • Assist in preparation of ANDA/NDA submissions in accordance with FDA regulations, ICH guidelines, USP methodologies, cGMPs and Saptalis SOPs.
  • Write/review responses to FDA deficiency letters for pending ANDAs/NDAs.
  • Provide support in writing/reviewing QOS, QbD, Product Development Reports, Executed Batch Records, etc to assure GMP Compliance during formulation development.
  • Audit regularly the current practices in the Company for regulatory compliance with SOPs and cGMPs and recommend and implement corrective measures with regards to regulatory compliance.
  • Assist Raw material sampling, monitor ANDA/GMP batch manufacturing and placement and pull of stability samples as per approved stability protocols.
  • Assure that all R&D activities are documented as per cGLP and cGMP compliance.
  • Assist during external audits and inspections of the facility by regulatory agencies. Reviews courses of action, responses, and monitors follow-up to customer audits of the facility.
  • Assist with mock FDA inspections (both routine and PAI) for the preparation of such inspections and assist with the facility’s state of preparedness.
  • Provide regulatory input for deviations, investigations, Out of Specifications (OOS) and Out of Trend (OOT), batch failures, and customer complaints.
  • Assist with the implementation of pharmacovigilance program according to FDA requirements.
  • Assist the Quality department for the recall of commercial products and shall actively engage with any customers and regulatory agencies involved.
  • Assist GMP and Pre-Approval Inspections conducted by FDA
  • Prepare the responses to any observations by FDA following periodic plant inspections.
  • Assist in preparing and reviewing the Annual Product Reports and Reviews.
ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:
  • Familiarity with regulatory requirements for filing quality submissions to USFDA for pharmaceutical product development and approval process.
  • Sound knowledge of regulatory environment and thorough understanding of FDA requirements are essential.
  • Excellent verbal, written and documentation skills.
  • Strong organizational skills, attention to detail, and the ability to work in a team environment.
  • Ability to multi-task with high efficiency.
EDUCATION AND EXPERIENCE:
  • BS/M.S. in Regulatory Affairs, Pharmaceutical Sciences, Chemistry, Life Sciences, or related discipline with 1-3 years of experience in pharmaceutical industry.
  • Experience in regulatory filings for ANDAs, NDAs etc. to USFDA is preferred.

Send your resume to info@saptalis.com

Manager, Regulatory Affairs

Saptalis is looking to recruit a Manager, Regulatory Affairs to join our team at our facility in Hauppauge, NY.

Manager, Regulatory Affairs is responsible for regulatory submissions including ANDAs and NDAs. Provide necessary updates to submissions or responses to resolve any filing deficiencies. Review and approve all the required technical documentation to develop a product and successfully transition to commercial manufacture. Handle the post-approval regulatory activities such as filing annual reports and PADERs once the products are approved. Evaluate, advise, and approve regulatory impact of changes to manufacturing processes, specifications, and components. Coordinate external audits and inspections of the facility by regulatory agencies. Provide regulatory input for deviations, out of specifications (OOS) investigations, batch failures, and customer complaints. Supervise the implementations of pharmacovigilance program according to FDA requirements. Responsible for the development and implementation of quality system to describe how the firm complies with cGMPs and operates to maintain a state of control. Work with various tools such as eCTD software and SPL Editor. Excellent organization, verbal, written and documentation skills are required.

Job Description:
  • Provides Regulatory Affairs oversight and compliance support for new products in development and commercially marketed products.
  • Prepares regulatory submissions including ANDAs, NDAs, Pre-INDs, INDs etc. as per current USFDA requirement. Provides necessary updates to submissions or responses to resolve any deficiencies
  • Works with various software tools such as eCTD software and SPL Editor.
  • Provides CMC strategic guidance and functions as the internal Compliance resource and is expected to monitor regulatory agency publications, proposed guidances, inspection reports, and expectations to determine trends and areas of compliance emphasis.
  • Functions as a regulatory consultant for external clients when necessary. Must be able to successfully defend these documents when questioned during customer audits and regulatory agency inspections.
  • Reviews associated technical reports, control procedures, processing procedures, validations, test methodologies, and other required documentation which are necessary to both develop a product and also successfully transition it into routine commercial manufacture.
  • Handles the post-approval regulatory activities such as filing annual reports and PADERs once the products are approved.
  • Provides CMC strategy to ensure the approval of commercial manufacturing submissions.
  • Evaluates, advises and approves the regulatory impact of changes to manufacturing processes, specifications, impurities, polymorphs and/or particle size and components.
  • Coordinates external audits and inspections of the facility by regulatory agencies. Reviews courses of action, responses, and monitors follow-up to customer audits of the facility.
  • Assists with mock FDA inspections (both routine and PAI) for the preparation of such inspections and assist with the facility’s state of preparedness.
  • Assists Quality department, as necessary, with internal & external activities with regard to customer complaints. This shall include participating in the investigation, determining corrective actions, advising upper management on the best course of action and preparing responses and correspondence to the customer for their signature.
  • Provides regulatory input for deviations, investigations, Out of Specifications (OOS) and Out of Trend (OOT), batch failures, and customer complaints.
  • Supervises the implementations of pharmacovigilance program according to FDA requirements.
  • Coordinates with Quality department for the recall of commercial products and shall actively engage with any customers and regulatory agencies involved.
  • Assists GMP and Pre-Approval Inspections conducted by FDA
  • Prepares and reviews responses to any observations by FDA following periodic plant inspections.
  • Review and approve the Annual Product reports and reviews.
ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:
  • Thorough understanding of regulatory requirements for filing quality submissions to USFDA for pharmaceutical product development and approval process.
  • Excellent Knowledge in understanding cGLPs and cGMPs to develop quality pharmaceutical drug products.
  • Sound knowledge of regulatory environment and thorough understanding of FDA requirements are essential.
  • Excellent verbal, written and documentation skills.
  • Strong organizational skills, attention to detail, and the ability to work in a team environment.
  • Ability to multi-task with high efficiency.
EDUCATION AND EXPERIENCE:
  • BS/M.S. or Ph.D. in Regulatory Affairs, Pharmaceutical Sciences, Chemistry, Life Sciences, or related discipline with 3-12 years of experience in pharmaceutical industry.
  • Experience in regulatory filings for ANDAs, NDAs etc. to USFDA is a must.

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

QA Analytical Data Reviewer/Auditor

Saptalis is looking to recruit a QA Analytical Data Reviewer/Auditor to join the growing Quality group at our facility in Hauppauge, NY.

QA Data Reviewer/Auditor is responsible for GMP and technical review of method validations, raw material/in process/finished product/stability data for release. In addition, the responsibilities include supporting lab investigations, customer/agency audits and performing analytical testing as needed.

Job Description:
  • Review analytical laboratory data packages and laboratory notebooks and assure that all testing is performed as per GLP requirements and Saptalis SOPs.
  • Review and audit release testing of raw materials and packaging components as per compendia or approved methods.
  • Review and audit in-process, finished product/release and stability testing of dosage forms as per approved methods.
  • Review analytical methods, method validation protocols, method validation reports, method transfer protocols/reports, cleaning validation protocols, reports and methods, raw material specifications, product specifications, SOPs and other GMP technical documents.
  • Audit the laboratory routinely and assure that all personnel are trained and all testing equipment is with in calibration and laboratory operates with GMP compliance at all times as per FDA regulations and Saptalis SOPs.
  • Review audit trails on data acquisition systems, equipment calibration status and assure that data integrity is maintained at all times.
  • Assist in conducting OOS, OOT and other Quality investigations to determine root cause for failure results and implement corrective actions.
  • Assure that all activities are documented in assigned laboratory notebooks as per Saptalis procedures and cGLPs.
  • Assist Management team during Pre-Approval and general GMP inspections by the USFDA and external auditors.
  • Assist with the CAPA and Change Control Systems.
  • Review and approve cGMP documentation including procedures, validation protocols, development reports, specifications and other related documents.
  • Develop and maintain metrics and trending reports for Compliance-related activities.
  • Review and assist in product complaint investigations.
  • Collaborate with departments and external suppliers regarding quality concerns.
Qualification:
  • BS/MS Degree (preferred in chemistry or equivalent)
  • At least 2-5 years of testing and data review and cGMP experience
  • Knowledge of HPLC/GC principles and ability to review data for accuracy and completeness
  • Ability to assess problems, to identify solutions, to plan and implement necessary changes
  • Experience in quality systems auditing (internal and/or external) preferred
  • Knowledge of cGMP regulations and validation principles
  • Ability to work well in a team-oriented environment
  • Well-developed communication and technical writing skills
  • Ability to multi-task with high efficiency
  • Ability to work well under pressure and maintain efficiency both on an individual and team basis
Position Benefits:
  • Works cross-functionally and receives exposure to several departments.
  • Potential for career growth within an expanding QA/QC team as well as other areas.
  • Medical, Dental, Vision and 401K plans are offered.

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

X

Exercitation ullamco laboris nis aliquip sed conseqrure dolorn repreh deris ptate velit ecepteur duis.

Get in touch