Analytical Development Chemist

工作内容

*Description:*

The chemist, Pre-Formulation development is responsible for all activities including extractable/leachable studies for the manufacturing components and packaging materials for a large variety of liquid dosage forms. Job Responsibilities:

• Perform chemical compatibility and extraction studies on the manufacturing components and packaging components, using instruments such as HPLC, LC-MS and GC.
• Develop, validate, write-up and review new analytical methods, including leachales methods.
• Possess knowledge of regulatory guidance in the area of formulation and submission requirements, such as for extractable/leachable knowledge and USP 665 1665, 1663 and 1664.
• Perform additional analytical testing on in-process and manufacturing samples, as required.
• Conduct experiment in trouble-shooting of formulations, OOS results and packaging components.
• Utilize more complex problem solving techniques to identify root cause of issues with internal customers and determine cause of action required
• Liase with peers within the organization in the resolution of technical issues.
• Perform all lab duties in compliance with SOP/SOD, GMP, SWP and company policies.
• Attend departmental meetings, internal and external training meetings.
• All other relevant duties as assigned.
• Skills:*
  
  

chemistry, hplc, method validation, method development, development, research & development

• Top Skills Details:*
  
  

chemistry,hplc,method validation,method development,development,research & development

• Additional Skills & Qualifications:*
  
  

Education:

University degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering

Excellent working and theoretical knowledge of HPLC, GC, LC-MS, IC, UV and FT-IR Over 5 years of working experience in analytical sciences laboratory, preferably in a pharmaceutical development environment Knowledge of GMP, GLP, Safety, FDA and TPD guidelines such as USP1665, 665, 1663 and 1664 about extractables/leachables

• Experience Level:*
  
  

Expert Level

À propos d’Actalent:

Actalent relie la passion à la mission. Nos solutions de candidats talentueux et la performance de nos services produisent la valeur et les résultats, tout en apportant la compétence qui permet à nos clients de réaliser plus. Nos experts situés dans le monde entier inspirent au quotidien. Nous soutenons les initiatives essentielles en ingénierie et en sciences, par les expériences qui favorisent un développement continu. La différence, c’est nos gens. Actalent est une société d’exploitation d’Allegis Group, leader mondial des solutions de candidats talentueux.

L’entreprise souscrit au principe d’égalité d’accès à l’emploi et prendra en compte toutes les candidatures sans distinction de race, sexe, âge, couleur, religion, nationalité, statut de vétéran, handicap, orientation sexuelle, identité sexuelle, information génétique ou toute autre distinction protégée par la loi.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.