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Analytical Staff Scientist (HPLC, Method Development) in Devens, MA at Apex Life Sciences

Date Posted: 11/22/2018

Job Snapshot

Job Description


Analytical Staff Scientist

  • Development, validation, qualification, and implementation of analytical test methods in support of process research, discovery research, GMP production, and stability testing with particular emphasis on HPLC, GC, and LC-MS methods.
  • Troubleshoots analyses and performs investigations. 
  • Provide advice, guidance, and direction to junior chemist and scientist on technical and project management issues for analytical development projects.
  • Analyzes research and productions samples. 
  • Prepares scientific reports and documents, presents analytical findings to teams and clients, and uses scientific literature to solve advanced technical problems. 
  • Prepares and reviews SOPs, test methods, scientific reports, data and other GMP/regulatory documentation. 
  • Applies scientific knowledge (both theoretical and practical) for the resolution of analytical chemistry problems. 
  • Contributes to the technical growth of the department and company. 
  • Participate in project management activities including: creating and meeting objectives for timelines, budgets, and project goals. 
  • Assists with scientific/project proposals. 
  • Contributes to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed. 
  • Reports all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated. 
  • Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc. 
  • Demonstrates technical and procedural proficiency and self-assuredness in applying EH&S standards. 
  • Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department. 
  • Provides leadership for employee relations through effective communication, coaching, training, and development, and ensures staff acts in accordance with policies and practices with respect to GMP, environmental, health, and safety (EH&S) and other related regulatory requirements. 
  • Support the Company’s commitment for environmental health & safety by applying ISO 14001, OHSAS 18001, and Sustainability 2025 principals into daily activities. 
  • Interacts with internal and external clients. Moderate travel may be necessary for technical meetings, customer visits, and supplier contacts. 

Requirements

  • PhD in Analytical Chemistry with a minimum of 3 years’ experience in a GMP environment. 
  • Minimum of 3 years’ experience in method development and validation for Active Pharmaceutical Ingredients (APIs). 
  • Experience with Process Development of APIs. 
  • Excellent analytical, written and verbal communication skills. 
  • Experience with HPLC, GC, LC-MS, GC-MS, IC, spectroscopy, and wet chemicals. 
  • Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents. 
  • Ability to write clear and concise technical reports, business correspondence and procedure manuals. 
  • Ability to lead projects and provide direction to various levels of BS analytical Chemists and Scientists. 
  • Effective communication with clients. 
  • Experience mentoring staff members in an analytical department. 
  • Formal project management training. 
  • Ability to work independently and in a team environment. 
  • Ability to positively resolve conflict. 
  • Experience with writing method validation protocols and reports. 

For immediate consideration, email your resume to Eschaffer@apexlifesciences.com with the subject 'Staff Scientist' 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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