Director, Analytical Services
Ash Stevens Inc., a developer and contract manufacturer of active pharmaceutical ingredients (APIs) for the pharmaceutical industry, is seeking a highly motivated, experienced analytical chemist to support and direct our analytical development and quality control functions. This individual will be responsible for all of the company’s analytical services ensuring that they meet company requirements and current FDA/ICH guidelines. The qualified individual will have a Ph.D. in Chemistry with a minimum of ten years experience in pharmaceutical analytical chemistry. Candidates with a Masters degree in Analytical/Organic/Medicinal Chemistry and 15 years of relevant experience will also be considered. A proven track record in the management of a FDA regulated (cGMP) quality control department is mandatory. The successful candidate will be a high energy individual and have the initiative to support (hands-on) analytical development in a fast paced, diversified and responsive analytical department. Expertise in analytical methodology, using both modern methods and classical techniques including but not limited to structure elucidation of organic molecules (NMR, IR, UV and mass spectrometry) determination of purity and stability (HPLC, GC, SFC), moisture content, residual solvent analysis, optical rotation, fluorimetry, and ICP.

Ash Stevens is located south of Detroit in Riverview, Michigan.

KEY RESPONSIBILITIES:
1. Analytical Chemistry

  • Selection of appropriate analytical testing methods and specifications for raw materials, GMP starting materials, intermediates, and final pharmaceutical products (APIs)
  • review and approve new analytical methods
  • understand packaging requirements, cleaning procedures/verification and cleaning method development
  • microbiological requirements
  • ensuring analytical equipment in use is adequately maintained per SOPs
  • Ensure development and validation of analytical methods is appropriate for the phase of development
  • conduct analytical method development (MD) activities as required
  • review MD activities and data
  • develop and review of analytical specifications
  • prepare validation protocols per ICH guidelines
  • prepare and/or review of validation data and reports
  • review of client/ASI generated analytical transfer protocols
  • Ensure stability studies appropriate for given phase of development are conducted
  • Prepare/review of stability protocols, with storage conditions, calculate sample requirements, packaging to match bulk API configuration, etc.
  • critically review stability data and prepare interim and final reports
  • review shelf-life data and prepare summaries
  • Establish Analytical Reference Standards (ARS) as required
  • participate in generating the testing/retesting protocol for ARS
  • generate ARS CoA and assign retest dates
  • review analytical testing packages for ARS qualification

2. Project Initiation and Assessment

  • Assist as needed in communicating and explaining ASI’s capabilities to customers
  • Participate in assessment of potential new projects
  • Provide ASI Vice President(s) or Project Manager technical input regarding the feasibility of the project

3. GMP Compliance

  • Expertise in GMP regulations/requirements/audits
  • Ensure analytical tests of chemicals occurs per GMP guidelines
  • Conduct investigations of OOS, deviations and failure incidents per GMP guidelines

4. Management

  • Conduct performance reviews of direct reports and support reviews for other departments
  • Develop and maintain a strategic plan for what services will be performed in-house vs. contracting with an outside vendor
  • Present a monthly technical report to the ASI President and Senior Management. Actively participate in technical talks to find solutions to different problems and carefully consider opinions and suggestions for future work
  • Interact with Quality Assurance, Engineering, Safety, and Operations Departments as needed in support of business objectives
  • Participate in meetings with potential clients and brokers to provide input to ASI’s Senior Management about technical aspects of potential business opportunities for ASI. Interact with clients in a positive and constructive manner. People oriented management style an asset
  • Work with clients for an efficient transfer and implementation of the technological/analytical information
  • Provide technical expertise at request to all ASI departments and employees

EXAMPLES OF JOB TITLES SUPERVISED:
Sr. Analytical Chemists (QC Manager, Analytical Development)
Analytical Chemists/analysts

SUPPORT OF ASH STEVENS’ MISSION AND VALUES:
An important component of good performance for all Ash Stevens staff members is the consistent support and practice of Ash Stevens’ Mission and Values.

OTHER RESPONSIBILITIES:
Promote a friendly and cooperative environment among all members of ASI and specifically the QC department in order to facilitate free communications and initiative. Strongly encourage teamwork and carefully consider and analyze other people’s opinions.

Skills and Abilities:

  • Attention to detail a must
  • Self-motivated, creative and independent scientist with a strong background in Analytical, Organic and/or Medicinal Chemistry
  • Wide knowledge of classic and modern analytical methods and the ability to direct projects covering a variety of chemical compounds are required
  • Willingness to do paperwork, manage documentation as required to get the job done
  • Hands-on chemistry to generate simple and accurate solutions on a daily basis is a desired strength
  • Ability to conduct research as well as developmental work in the field is required
  • The ability to direct and interact with associates is also an important requirement of the position
  • Office suite computer skills
  • Excellent written and verbal communication skills


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