Job Opportunities

Chemist, Analytical Research & Development

Job Summary

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

Responsibilities and Duties

 

  • 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 with in 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. 

Qualifications and Skills

  • Minimum BS/BA degree in Chemistry or Chemical Engineering is required. 
  • 1-2 years of analytical method HPLC development, and general wet laboratory experience is essential.
  • 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 detailed-oriented manner.
  • Ability to work on multiple projects in a concurrent manner.
  • Strong interpersonal skills and excellent oral and written communication skill a must
  • 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

 

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

Director Analytical Development / Support

Job Summary

We seek a PhD-level organic analytical chemistry leader with excellent peptide as well as small molecule analysis expertise to advance peptide and small molecule drug development in the laboratory. The successful candidate is a proven leader who 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 Responsibilities include lead and direct a team of scientists
working in*: 

  • Development and validation of LC, LC/MS, GC, GC/MS, ICP-MS and other wet chemical methods for actives, impurities, extractables/leachables, degradation and related compounds in drug products and accelerated stability samples.
  • Preparation and review of method validation protocols and validation reports
  • Operation and maintenance of LC, GC, LC-MS, GC-MS, ICP-MS (Thermo Finnigan instruments) and other instruments needed for impurity characterization
  •  Develop analytical methods for peptide characterization using SEC, SEC-MALLS, SDS-PAGE/CE-SDS, RLD, AUC, FFF, Photon Correlation Spectroscopy (PCS) and LC/MS
  • Draft, review, and approve analytical reports
  •  Write scientific 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 of specifications and specification justifications
  • Maintain the instruments used for the physical characterization of powders and dissolution apparatus

*Responsibilities will be more comprehensive for more senior positions 

Requirements

  • 5-15 years’ experience in peptide analysis at a scientific organization; experience at a pharmaceutical                  company preferred.
  •  Exceptional knowledge of organic chemistry, peptide chemistry in particular, and wet chemistry analysis
  • Track record of scientific contributions; publications and patents preferred
  • Experience in mentoring and guiding junior scientists
  • Flexible, optimistic attitude

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

Manager, Peptide Analytical 

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 techciques.
·        Preparation and review method validation reports.
·        Operation and maintenance of LC-MS,GC-MS, ICP-MS (Thermo Finnigan instruments) and other instruments               needed forimpurity 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

Requirements

 

·        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.

·        Flexible, optimistic attitude.


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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