Job Opportunities

Chemist, Analytical Research & Development

Job Summary

Scientist in the analytical group and to support the analytical methods development and quality control activities for Odin’s portfolio of injectable and ophthalmic drug products. He/She must have a strong initiative and desire to work in a fast paced, team-oriented, dynamic environment.

Responsibilities and Duties

  • Development and qualification of cGMP analytical methods for lot release and stability testing of products
  • Manage method transfers and qualification with CMOs and CROs
  • Guide the analytical characterization of products including preparation of standards
  • Serve as technical resource for analytical method issues
  • Ensure analytical support for products and conjugation process development
  • Prepare SOPs, protocols, scientific reports and technical documents for external publication
  • Identify new analytical technologies
  • Conduct stability and process characterization/validation studies in support of IND filings under GLP or GMP environment
  • Critical scientific/technical data analysis and presentation of data in project team meetings
  • Other duties may be assigned

Qualifications and Skills

  • Ph.D/ M.S. in Analytical Development or Quality Control or related fields with 2+ years of hands-on laboratory experience , preferably in the biotech/biopharmaceutical setting
  • Experience with standard analytical methods HPLC, UV spectroscopy, FT-IR
  • Ability to think critically and creatively to identify and solve scientific problems
  • Experience with operating under GMP’s and CRO/CMO’s management a plus
  • Ability to work independently and manage multiple projects simultaneously
  • Strong interpersonal skills and excellent oral and written communication skill a must
  • Physical ability to lift up to 20lbs and work at the lab bench for extended periods of time

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

Experience 

  • Laboratory: 2 years (Preferred)

Education

  • Doctorate (Preferred)
  • Masters (Required

Job Type

  • Full-time

Salary

  • Dependent on level of qualifications

Formulation Scientist/              Principal Scientist

Job Summary

The Formulation Scientist is primarily responsible for 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 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 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 level of qualifications

QC Lab Manager

Job Summary

Oversee operations of the Quality Control (QC) laboratory, including pharmaceutical product R&D (Research and Development) and Analytical Development activities using HPLC/UPLC, Gas Chromatography, LC-MS, GC-MS, ICP-MS, Ion Chromatography, UV Spectrometer, Particle size analyzer, Dissolution apparatus, Electron Microscopy and Differential Scanning Colorimeter. Analyze, Review and Audit Results and for further processing and release; Write protocols, Review and approve Analytical Instrument qualifications documents for cGMP; Review process/cleaning validation protocols and reports, Analytical Method Verification and Validation protocols/reports; Review and approve Annual product review reports (APR); Analyze drug testing results and documents for raw materials and drug product specifications, test methods, protocols; Review and approve chemical and analytical work products and technical reports for ANDA and FDA compliance; Develop and implement systems to improve QC laboratory cGMP compliance and productivity; Execute protocols of QC activities, including raw material, finished product, process raw material, process validation, stability microbiology; Write and submit CMC analytical documents for ANDA submission; Participate in cGMP and regulatory preapproval audits; Perform investigation of out-of-specification laboratory results and implement appropriate corrective and preventive measures; Supervise 7 employees.

Qualifications and Skills

  • Must have a Master’s Degree or its equivalent (Bachelor’s Degree plus 5 years experience inclusive of 2 years experience in job offered or as a Pharmaceutical Scientist) in Chemistry or Pharmaceutical Science plus 2 years experience in job offered or as Pharmaceutical Scientist. 

  • Require skills and knowledge in HPLC/UPLC, CMC, ANDA, Differential Scanning Colorimeter, and Electron Microscopy. 

Job location

Somerset, NJ. Submit résumé referencing job code SAS011 to HR, Odin Pharmaceuticals, LLC, 300 Franklin Square Drive, Somerset, NJ 08873.

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

Associate Director, Formulation

Job Summary

Research, analyze, and perform formulation of injectable and ophthalmic dosage forms, including sterile dosage forms, nano suspensions, lyophilized dosage forms, microspheres, and liposomes of pharmaceutical drug products; Conduct initial project evaluation for new projects and propose formulation and process development strategies; Guide the development of formulation and process Scale up from laboratory scale to ANDA/NDA submission; Provide formulation and process expertise to troubleshoot issues with approved and existing generic drug products; Respond to CMC FDA deficiency letters (IR, DRL, or CRL) to obtain timely approval of products; Review, and approve FDA submission documents including original pre-IND and IND submissions, amendments, product development reports, quality overall summaries; Supervise 3 chemists.

Qualifications and Skills

  • Must have a Master’s Degree in Chemistry, Pharmaceutical Science, or Pharmaceutical Biotechnology plus 2 years experience in job offered or as Sr. Principal Research Scientist.
  • Require skills and knowledge in Injectable/ophthalmic dosage forms, Scale up, sterile dosage forms, lyophilized dosage forms, nano suspensions, CMC, FDA guideline, ANDA. 

Job location

Somerset, NJ. Submit résumé referencing job code PRA002 to HR, Odin Pharmaceuticals, LLC, 300 Franklin Square Drive, Somerset, NJ 08873.

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

Associate Manager, Analytical R&D

Job Summary

Associate Manager, Analytical R&D (Somerset, NJ) – Lead analytical research, method development, and analytical services of pharmaceutical drug products and chemicals for ANDA submission using HPLC/GC, Method Validation, Swab analysis, IQ/OQ/PQ; Develop and implement sample analysis for Assay and Impurities in accordance with cGMP/GLP regulations; Coordinate and prepare for internal and FDA audits; Analyze CAPA reports and review Root Cause Analysis to implement appropriate actions to correct/prevent chemical and manufacturing control deficiencies; Implement analytical SOPs to ensure regulation compliance; Supervise 6 chemists. 

Qualifications and Skills

  • Must have a master’s degree or its equivalent (Bachelor’s Degree plus 5 years experience inclusive of 2 years experience in job offered or as a Group Leader) in Chemistry or Pharmaceutical Science + 2 years experience in job offered or as Group Leader. 
  • Req skills and knowledge in HPLC/GC, Method Validation, Swab analysis, IQ/OQ/PQ, ANDA, CAPA, Root Cause Analysis, SOPs. 

Job Location:

Somerset, NJ. Send rés w/code KUP003 to HR, Odin Pharmaceuticals, LLC., 300 Franklin Square Drive, Somerset, NJ 08873. 

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

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