Job Opportunities

Current Open Positions

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

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.

Qualifications and Skills

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

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

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 and 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

Introduction

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.

Job Type

  • Full-time

Introduction

We are looking for driven and detail-oriented chemists that would be interested in joining Odin Pharmaceuticals, a pharmaceutical company focused on sterile injectables and ophthalmics. The company was founded by industry pioneer Veerappan Subramanian earlier in 2018 and will be expanding rapidly over the next 36 months with considerable capital expended on research and development equipment and infrastructure. This is an excellent opportunity for entry level and mid-level employees to learn and advance in their career as they will be involved in planning and qualifying as well as operating a new laboratory with state-of-the-art equipment.

Job Summary

Tasks associated to pharmaceutical analysis intended for drug product development. The preliminary activities include following schedules, direction of compendia standards and in-house standard operating procedures to analyze pharmaceutical drug substance, excipients, drug product testing for release and stability samples.

Responsibilities and Duties

  • Perform quantitative analysis for pharmaceutical drug-substances, excipients and drug products using USP/NF, EP, in-house test methods and standard protocols, maintaining full compliance with all applicable US FDA – cGMP regulations and internal SOPs.
  • Utilize techniques of Spectrophotometry, UPLC, HPLC, GC, dissolution, and wet chemistry tests in accordance with the USP.
  • Interpret and communicate analytical results.
  • Contribute to technical problem solving and troubleshooting as needed.
  • Contribute towards optimizing laboratory operations to increase efficiency and GMP compliance.

Experience

  • 0-2 years

Qualifications and Skills

  • Enthusiasm and dedication performing as an individual contributor and in a team environment.
  • Written and verbal communication and presentation skills.
  • Ability to set priorities and to follow through on commitments utilizing organizational skills.
  • Microsoft Office and ability to learn additional software/programs as needed.
  • Creativity to solve technical and compliance problems.

Specialized Knowledge

  • Knowledge of US FDA- cGMP and Standard Operating Procedures (SOP).
  • Understanding of analytical chemistry and analytical laboratory procedures.
  • Background of modern analytical laboratory techniques and use of UPLC, HPLC, GC, TLC, UV, dissolution, and other analytical equipment.
  • Some knowledge of analytical method development, validation, and method transfer.

Education

  • Bachelor’s Degree (BA/BS) Chemistry or related science – Required
  • Master’s degree (MS/MA) Chemistry or related science – Preferred

Job Type

  • Full-time

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