Now Hiring - Pharmaceutical Team Lead, Analytical Development in Riverview, MI

POSITION SUMMARY: The Team Lead – Development Analytical Services is responsible for the development of new analytical methods, identification and characterization of process impurities through their knowledge and experience of analytical and organic chemistry.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Shall adhere to all regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Ash Stevens’ mission and values.
• Identify and protect the original technical information as part of the company property.

Key accountabilities:

Include but are not limited to:

· Point of contact and lead for new projects and projects undergoing development.

· Manage a team of scientists who will develop analytical methods (for in-process control, cleaning verification control, residual solvents control, etc.) that can be used by both Quality Control and Process Development departments. Includes HPLC, GC, IR, LCMS, KF, and ROI and may extend to other testing procedures as well.

· Ensures the development of the methods are documented appropriately or future reference. Prepares and reviews test methods and supporting documentation for use in the laboratory.

· Develop and train team members on systems and processes to be independent project leads.

· Assesses resource requirements and schedules resources to support operation’s need for timely testing

· Assist in the preparation of new or revised documentation as required.

· Perform analytical tests to evaluate starting materials, intermediates, and APIs.

· Assist in the maintenance, troubleshooting, and calibration of laboratory analytical instrumentation including but not limited to NMR, HPLC and GC. Maintain accurate records regarding maintenance and calibration activities.

· Document sample preparation, equipment set-up and test results in laboratory notebooks or appropriate test record forms. Maintain laboratory log sheets, for example, those related to equipment usage, calibration, maintenance, reference standard inventory, QC chemical inventory, or those related to retention samples.

· In addition to routine housekeeping and glassware cleaning, maintain appropriate inventory of supplies and chemicals.

· Provide accurate and timely test results as required.

· Actively participate in technical discussions with clients and provide updates on project progress where required.

· Perform delegated activities as required

EDUCATION/EXPERIENCE:

· Team Lead – Analytical Services will have a Ph.D. in Analytical, Organic, or Medicinal Chemistry and four (4) years’ experience, a Master’s Degree and ten (10) years’ experience, or a Bachelor’s Degree and Fifteen (15) years’ experience in a related environment.

· Excellent knowledge of analytical and organic chemistry as well as chemical safety.

· Experience with de novo method development

· People management desirable.

job competencies:

· Excellent organizational and planning skills.

· Strong written, verbal, and interpersonal communication skills.

· Self-motivated, creative, and independent.

· Ability to direct projects covering a variety of chemical compounds.
Familiarity with cGMP, plant safety, and EPA requirements

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Relocation assistance
• Vision insurance

Schedule:

• 8 hour shift

Work Location: One location