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Director of Analytical Chemistry

Richmond, VA

Posted: 02/03/2021 Job Number: JN -022021-12485

Job Description

Director of Analytical Chemistry Manufacturing, Science & Technology (MS&T)
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Director of Analytical Chemistry Manufacturing, Science & Technology (MS&T)
  • Location: Richmond, VA (On-site, not remote)
  • Industry: Pharmaceutical
  • Hours: M-F, 8am-5pm
  • Employment Type: Direct hire
  • Salary: Competitive compensation package, bonus potential and excellent benefits package
Environment: Join a growing pharmaceutical manufacturing company dedicated to providing high-quality, low-cost pharmaceuticals through state-of-the-art, U.S. based advanced manufacturing processes. The company will manufacture precursor chemical ingredients, active pharmaceutical ingredients (API), and finished pharmaceutical products, domestically for essential medicines critical to the ones healthcare.

Responsibilities:
  • Provide technical expertise to ensure analytical chemistry aspects of development or manufacturing projects will meet objectives
  • Review, author and approve analytical chemistry documentation such as analytical test development reports and methods, validation protocols and reports, specifications, etc.
  • Contribute to the timely and accurate preparation of regulatory submissions
  • Lead continuous improvement opportunities throughout analytical method lifecycle
  • Manage multiple projects/workstreams and make sound and timely decisions based on business priorities
  • Assist as an analytical chemistry SME for CRO/CDMO/CMO audits
  • Collaborate with Project Management, Process Chemistry, Quality Assurance, Regulatory Affairs, and Engineering to ensure strong working relationships with all partners and company employees
Qualifications:
  • Minimum of 7 years working in related roles in the pharmaceutical industry demonstrating increasing responsibility
  • Strong track record of success in method development and qualification/validation of analytical methods
  • Strong interpersonal and communication skills
Preferred Qualifications:
  • MS (or equivalent based upon work experience) in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences or a related scientific field
  • Knowledge of ICH, cGMP and compendial pharmaceutical development requirements
  • Experience managing third-party vendors (CROs/CMOs/CDMOs)
  • Experience with compendial requirements and methods (e.g., general chapters, monographs, etc.) and associated method qualification industry practices
  • Experience with authoring or contributing to CMC sections of regulatory submissions (NDAs/ANDAs/DMFs)
  • Experience with small molecule API testing and characterization techniques (e.g., HPLC, GC, NMR, FTIR, UV/Vis, HRMS, DSC/TGA, salt/polymorph, PSD, etc.)
  • Experience with the design and implementation of process analytical testing technologies (PAT)
  • Experience with the design and execution of ICH stability studies and experience with injectables
  • Experience with microbiological quality and testing requirements
ADA/EOE
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