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Job Summary

The Analytical Research Scientist reviews and assesses analytical methods found in literature and provided in API supplier technical packages, perform analytical method development and validation activities, generates data in support of R&D formulation development work. The ARD chemists report to the ARD manager.

Major Role

  • Make sound technical knowledge regarding analytical method development using HPLC/UPLC, GC, and other techniques. Independently select techniques and approaches to solve problems within the discipline of analytical chemistry and method development.
  • Demonstrate basic wet chemistry laboratory skills such as sample preparation, HPLC runs and processing chromatography data according to written methods in a cGMP analytical laboratory environment.
  • Demonstrate technical understanding of analytical method development activities.
  • Without assistance, review and assess analytical methods contained within API technical packages and work to develop internal analytical methods for specific API and drug products
  • Employ appropriate techniques and methods to successfully execute laboratory work and issue documents within negotiated deadlines. Documents to be issued include but are not limited to, protocol preparation, analytical development reports, laboratory investigations, and analytical validation reports.
  • Use current methodologies to apply appropriate levels of statistical analysis to data generated and ensure Quality by Design within analytical development.
  • Conduct testing on routine/non-routine research and design experiments with minimal assistance in support of R&D formulation and process development work.
  • Maintain data integrity and ensure compliance with company SOPs, USP/Ph Eur, FDA, GDP, and cGMP regulation. Investigate deviations and write exception documents.
  • Maintain knowledge of relevant cGMP and safety requirements while building knowledge of other regulatory requirements related to R & D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
  • Effectively contribute solid analytical knowledge to a variety of projects with minimal assistance to functional or small project teams.
  • Responsible for maintaining the confidentiality of work assignments.

Qualifications and Skills:

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Minimum BS/BA degree in Chemistry or Chemical Engineering is required. One to two (1-2) years of analytical method HPLC development and general wet laboratory experience is essential.
  • Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
  • Requires superior writing skills.
  • Requires exceptional attention to detail with the ability to focus on current assignments. While Laboratory mistakes are unavoidable, they must be kept to a minimum due to their ramifications.
  • Requires initiative and self-motivation with moderate supervision in a detail-oriented manner.
  • Requires the ability to work on multiple projects in a concurrent manner.
  • Must possess the ability to work in an independent manner, as well as a group environment.

Physical Demands & Work Environment:

  • While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. Should be capable of lifting, carrying about 20 lbs.

Job Type

  • Full-time; 1st Shift

Job Summary

Support cGMP quality laboratory development and routine operations through testing, method development, method validation, and FDA deficiencies. Review of product test results, prepare, review protocol and report summaries.

Responsibilities and Duties

  • Responsible for leading the analytical aspects of a project while working with other functional areas to advance the through development pipeline.
  • Support new product development with advanced method development and validations for injectables and ophthalmic suspensions.
  • Technical transfer packages and generation of technical data to support regulatory requirements.
  • Hands-on experience in protein chemistry, micro/nanospheres. Perform and write reports on analytical lab work with high accuracy, attention to detail and consistency.
  • Demonstrate an aptitude for analytical chemistry and a desire to learn, develop, and contribute more.
  • Successfully use and troubleshoot instrumentation and methodological problems.
  • Perform analytical work to the standards required for both R&D and cGMP work. Independently design and execute degradation studies by following guidance from ICH and FDA.
  • Documentation, review, and approval of analytical test data.
  • Maintaining laboratory organization and supplies.
  • Keep and maintain a meticulous laboratory notebook with transparent scientific reasoning.
  • Understand and develop knowledge of FDA regulatory expectations.
  • Ensure testing is performed accurately and in accordance with GDP, GLP, cGMP, USP, and company standards.
  • Efficiently organize and plan daily activities and provide technical guidance and training to less experienced chemists.
  • Collaborate and work closely with project management and other colleagues in the sharing of resources, on-time delivery of results, and in managing project timelines effectively.
  • Demonstrate focus and ownership over projects and take initiative to resolve or appropriately escalate technical and operational bottlenecks to success.
  • Assist in the writing of complex documents such as test methods, protocols, technical reports, etc., as directed by Supervisor or Manager.

Qualifications and Skills

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Bachelor’s degree (B.A./B.S.) or equivalent in Chemistry, Analytical Chemistry, Biology, Chemical Engineering or related discipline. 5-8 years analytical/research laboratory experience required, preferably in a generic pharmaceutical.
  • Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
  • Requires exceptional attention to detail with the ability to focus on current assignments. While Laboratory mistakes are unavoidable, they must be kept to a minimum due to their ramifications.
  • Requires initiative and self-motivation with moderate supervision in a detail-oriented manner.
  • Requires the ability to work on multiple projects in a concurrent manner.
  • Must possess the ability to work in an independent manner, as well as a group environment.
  • Excellent written and oral communication skills are required. Strong attention to detail, people skills and ability to multitask are essential for success.
  • Balance time between work in compliance, testing, and teaching and supervision of analysts.
  • The ability to multitask and an aptitude to learn are essential to success in this position.

Physical Demands & Work Environment:

  • While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. Should be capable of lifting, carrying about 20 lbs.

Benefits

Work in a highly collaborative and motivated working environment
Participate in a comprehensive benefits package, including Health, Dental, Vision, Life Insurance, Short-term/Long Term Disability and participate in matching 401(k) plans

Job Type

  • Full-time

Job Summary

We seek an MS-level or PhD-level chemist with excellent peptide analysis expertise to advance peptide and organic small molecule drug development in the laboratory. The successful candidate will work cross-functionally with the internal analytical team, internal product development team, and external API suppliers to generate analytical methods for the submission of ANDAs.

Responsibilities and Duties

  • Development and validation of LC methods
  • Development of LC methods for impurities, including related compounds and degradation compounds, in drug products formulations and stability samples
  • Characterization of impurities utilizing LC-MS and other wet chemistry methods
  • Identify/characterize protein aggregates from developmental and stability samples
  • Study extractable/leachable from the container/closure system using LC/MS and GC/MS techniques.
  • Preparation and review method validation reports
  • Operation and maintenance of LC-MS, GC-MS, ICP-MS (Thermo Finnigan instruments) and other instruments needed for impurity characterization
  • Development of methods for the quantitation of low molecular peptides in drug products using LC/MS and other techniques
  • Draft, review, and approval of analytical reports
  • Response to CMC Deficiencies from the FDA
  • Review and evaluation of drug substance supplier’s technical documents
  • Identification of specification requirements for drug substances and critical raw materials and approval specifications and specification justifications

* Responsibilities will be more comprehensive for more senior positions

Qualifications & Skills

  • 5-15 years’ experience in peptide analysis at a scientific organization; experience at a pharmaceutical company preferred
  • Exceptional knowledge of organic chemistry and wet chemistry analysis
  • Track record of scientific contributions; publications and patents preferred
  • Familiarity with Waters chromatography systems and Empower software
  • Experience in mentoring and guiding junior scientists
  • A flexible, optimistic attitude

Job Type

  • Full-time

Job Summary

The Formulation Scientist is primarily responsible for the formulation development of generic and branded prescription products in injectable dosage forms as per FDA’s latest QbD guidelines for submission and approvals of ANDAs and NDAs.

Responsibilities and Duties

  • Development of drug formulations based on sound scientific principles
  • Procurement of branded products, APIs and inactive ingredients that meet regulatory standards
  • Deformulation of branded and other marketed products (Q1/Q2/Q3 evaluations)
  • Selection and procurement of packaging components
  • Optimization of lab formulations including stability studies
  • Scale-up formulations from lab to pilot plant to commercial quantities
  • Evaluation and procurement of laboratory equipment, pilot plant, and commercial equipment as needed
  • Manufacture R&D, Clinical and Exhibit batches
  • Develop product specifications for in-process, release and stability
  • Write all technical reports including Product Development Reports
  • Work closely with Analytical Research to deformulate and formulate ANDA/NDA/(505)(b) (2) products
  • Work closely with the Regulatory department to file ANDA/NDA/(505)(b)(2), develop responses for IRs and CRLs and PAS as needed.
  • Work closely with other departments such as Regulatory, Intellectual Property, Quality Control, Quality Assurance, Biopharmaceutics and Operations to get new ANDA/NDA/(505)(b) (2) products approved by FDA in a timely and efficient manner
  • Maintain up-to-date knowledge and expertise with relevant literature and FDA regulatory guidance including cGMP/cGLP
  • Maintain a high level of quality and regulatory compliance

Qualifications and Skills

Ph.D./Master’s in chemistry, chemical engineering or pharmaceutical sciences

Experience

Formulation Scientist

  • Ph.D. with 0 – 2 years’ experience or Master’s degree with 3 – 5 years’ hands-on experience in product development of generic or branded injectable and/or ophthalmic drugs.

Senior Formulation Scientist

  • Ph.D. with 3 – 5 years’ experience or Master’s degree with 5 – 7 years’ hands-on experience in product development, submission, and approvals in generic or branded injectable drugs.
  • Experience in depot ophthalmics, injectables, lyophilization, and controlled drug delivery preferred.
  • Experience in supervising and mentoring junior level scientists.

Principal Scientist

  • Ph.D. with 6 – 10 years’ experience or Master’s with 10+ years’ hands-on experience in product development, submission and approvals of generic or branded injectable drugs.
  • Experience in depot ophthalmics, injectables, lyophilization, and controlled drug delivery preferred.
  • Experience in supervising and mentoring junior/senior-level scientists.
  • Experience in product selection and strategies for development.

Education

  • Doctorate (Preferred)
  • Masters (Required)

Benefits

  • Work in a highly collaborative and motivated working environment
  • Participate in a comprehensive benefits package, including Health, Dental, Vision, Life Insurance, Short-term/Long Term Disability and participate in matching 401(k) plans

Job Type

  • Full-time

Salary

  • Dependent on the level of qualifications

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