Director of Clinical Trial Material Manufacturing
Avomeen Analytical Services, a fast growing Ann Arbor-based Chemical Analysis and Pharmaceutical Testing Laboratory, seeks an outstanding performer to join our team of scientists as a Director of Clinical Trial Material Manufacturing.
This individual provides appropriate resources and oversight to ensure full compliance with cGMP, corporate standards /policies/procedures, operational excellence, continuous improvement, personnel development and overall leadership.
- Accountable for leading the team to excellence in cGMP manufacturing of CTM, exploration of unique solutions for our customers, and developing the technical expertise of the organization.
- Design and conduct pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing. Conduct pre-formulation characterization and formulation development studies including routine and non-routine laboratory activities.
- Development of prototypes and/or production of trial samples, scientific review and specification of raw materials.
- Develop, validate and document new manufacturing methods to support formulation development.
- Manage the process and formulation development programs for new products.
- Independently plan and execute strategies for formulation development and solve complex problems.
- Conduct literature search for projects including publications, patents, etc.
- Review and author reports/documents such as product development reports, quality overall summary, master formulas and other key reports/documents.
- Maintain manufacturing equipment and support other lab organization tasks.
Qualifications and Experience
- B.S., M.S., or Ph.D. Degree in Pharmaceutical Sciences, Chemistry or equivalent with experience in the pharmaceutical industry and/or drug development.
- Minimum 2+ years of formulation development experience in pharmaceutical industry.
- Thorough knowledge of Good Manufacturing Practices. Knowledge of FDA regulatory guidances, ICH guidelines and requirements of ANDA submissions.
- Ability to effectively manage multiple projects under short time lines to produce high quality work. Must possess the ability to self-schedule in order to advance multiple programs simultaneously.
- Working knowledge of Microsoft suite of software products including Excel, Word and PowerPoint.
- Strong oral and written communication skills. Strong organizational skills with the ability to multi-task and prioritize assignments. Strong problem-solving skills are essential. Self-motivated with ability to work under pressure to meet deadlines.
- Top candidates will demonstrate a desire to advance and excel in their position while contributing to overall company growth.
- Ability to effectively function in fast-paced, dynamic technical environment.
- Desire to be part of a fast-paced, rapidly growing company.
The position offers major benefits and competitive salary, and the opportunity to quickly advance to positions of higher responsibility.
Avomeen Analytical Services is an Equal Opportunity Employer.
For more information, please contact us at (800) 930-5450.
To apply, send your resume to email@example.com