Associate Director, Analytical Development
This vacancy has now expired. Please see similar roles below...
Proclinical is currently seeking an Associate Director, Analytical Development for a pharmaceutical company located in New Jersey. Successful candidate will work collaboratively with cross-functional teams in support of drug development activities and is directly responsible for all aspects of analytical support for assigned projects. The position collaborates with colleagues in Process Development, Formulation Development, Safety Assessment, Quality Assurance, and Regulatory Affairs to ensure high quality, on time delivery to ensure on-time progression of Pre-Clinical, Clinical and Commercial programs.
Job Responsibilities
- Leading drug development Analytical activities to address key issues.
- Writing and reviewing technical documentation for regulatory submissions.
- Proposing appropriate drug substance and drug product specifications based on batch data and regulatory expectations.
- Assessing stability data and proposing shelf lives and retest dates that ensure the quality and safety of drug substances and drug products.
- Establishing external contracts with analytical CROs.
- Monitoring, reviewing and guiding the analytical activities at these laboratories to ensure timely delivery of quality analytical work packages.
- Acting as a technical advisor on analytical techniques used for qualitative and quantitative analysis of drug substance.
- Directing and/or performing hands-on laboratory work to solve atypical technical issues as needed.
- Implementing new and innovative analytical methods, and improving existing ones as needed.
- Authoring and reviewing SOPs to ensure quality and compliance within CMC.
Skills and Requirements
- MS or PhD required in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences or other relevant field.
- 10 years of pharmaceutical R&D experience. Must have thorough knowledge of GMP, Industry, and Regulatory requirements.
- Experienced in GMP, Industry and Regulatory requirements.
- Experience with authoring NDA/MAAs.
- Excellent oral and written communication skills.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-91653573_MT1
#Scientific
Related jobs
Highly Competitive Salary
Nordrhein-Westfalen, Germany
Aktuell suchen wir im Auftrag unseres Kunden, einen der führenden Vertreibern von GMP-zertifizierten, medizinischen Cannabisprodukten
Highly Competitive Salary
Bern, Switzerland
Proclinical is seeking a Power BI Developer who is passionate about data and analytics. This is a permanent position located in Bern, Switzerland.
Highly Competitive Salary
Menlo Park, USA
Proclinical is seeking a dedicated and technically skilled Senior External Manufacturing Engineer. This is a permanent position located in Menlo Park, CA.
Highly Competitive Salary
Neuchâtel, Switzerland
Proclinical is seeking a motivated and skilled Automation Engineer to join a dynamic team in the biotechnology and pharmaceutical industry.
Highly Competitive Salary
Philadelphia, USA
Proclinical is seeking a dedicated and enthusiastic Clinical Research Coordinator who is passionate about clinical-translational research in the field of head and neck cancer
Highly Competitive Salary
Philadelphia, USA
Proclinical is seeking a Payroll Analyst who will serve as a subject matter expert in payroll processing. This is a remote contract position.
Highly Competitive
Frankfurt am Main (60488), Germany
Proclinical are seeing a Clinical Application Specialist for a position based in Frankfurt.
£45000 - £55000 per annum
City of London, England
Proclinical are searching for a dedicated professional for a Senior Clinical QA Specialist (GCP).
Up to £0.00 per annum
Zürich, Schweiz
Proclinical are currently supporting is a global management and technology consulting group as they are looking to recruit a Senior SAP FI/CO Consultant in Zurich, Switzerland.
Highly Competitive
Crailsheim (74564), Germany
Proclinical are seeking a dedicated Technical Project Manager to lead software development projects in the medical technology field.