Job Summary

Support cGMP quality laboratory development and routine operations through testing, method development, method validation, and FDA deficiencies. Review of product test results, prepare, review protocol and report summaries.

Responsibilities and Duties

•  Responsible for leading the analytical aspects of a project while working with other functional areas to advance the through development pipeline.  Support new product development with advanced method development and validations for injectables and ophthalmic suspensions. Technical transfer packages and generation of technical data to support regulatory requirements.  Hands-on experience in protein chemistry, micro/nanospheres.  Perform and write reports on analytical lab work with high accuracy, attention to detail and consistency.  Demonstrate an aptitude for analytical chemistry and a desire to learn, develop, and contribute more.  Successfully use and troubleshoot instrumentation and methodological problems.  Perform analytical work to the standards required for both R&D and cGMP work.  Independently design and execute degradation studies by following guidance from ICH and FDA.  Documentation, review, and approval of analytical test data. Maintaining laboratory organization and supplies.  Keep and maintain a meticulous laboratory notebook with transparent scientific reasoning.  Understand and develop knowledge of FDA regulatory expectations.  Ensure testing is performed accurately and in accordance with GDP, GLP, cGMP, USP, and company standards.  Efficiently organize and plan daily activities and provide technical guidance and training to less experienced chemists.  Collaborate and work closely with project management and other colleagues in sharing of resources, on-time delivery of results, and in managing project timelines effectively.  Demonstrate focus and ownership over projects and take initiative to resolve or appropriately escalate technical and operational bottlenecks to success.  Assist in the writing of complex documents such as test methods, protocols, technical reports, etc., as directed by Supervisor or Manager.

Experience

5-8 years analytical/research laboratory experience required, preferably in a generic pharmaceutical.

Physical Demands & Work Environment

•  Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.  Requires exceptional attention to detail with the ability to focus on current assignments. While Laboratory mistakes are unavoidable, they must be kept to a minimum due to their ramifications.  Requires initiative and self-motivation with moderate supervision in a detail-oriented manner.  Requires the ability to work on multiple projects in a concurrent manner.  Must possess the ability to work in an independent manner, as well as a group environment.  Excellent written and oral communication skills are required. Strong attention to detail, people skills and ability to multitask are essential for success.  Balance time between work in compliance, testing, and teaching and supervision of analysts. Ability to multitask and an aptitude to learn are essential to success in this position. While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. Should be capable of lifting, carrying about 20 lbs.

Education

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Bachelor’s degree (B.A./B.S.) or equivalent in Chemistry, Analytical Chemistry, Biology, Chemical Engineering or related discipline.

Job Location

• 300 Franklin Square Drive, Somerset, New Jersey - 08873

Job Summary

Perform chemical and physical testing for complex inhalation product formulations under general supervision. Conduct testing in a cGMP laboratory and document those experiments per cGMP requirements. Calculate, organize, and communicate results using standard data templates and reports. Provide general laboratory assistance including planning, designing, and executing experiments. Edit SOPs, protocols, methods, and reports.

Responsibilities and Duties

• Perform analytical testing for inhalation products according to the established testing method, per cGMP requirements.
• Analyze samples, process data, and document in a laboratory notebook.
• Organize and maintain the functionality of the lab.
• Edit SOPs, protocols, methods, and reports.
• Self-motivated with moderate supervision in a detail-oriented manner
• Can work independently as well as in a group environment.
• Plan, design, and execute experiments with guidance from supervisor/senior staff.

Qualifications and Skills

• Possess good organizational skills, a commitment to quality work, and good oral and written communication skills.
• Work effectively as part of a team.
• Experienced with HPLC, GC, KF, FTIR, or other analytical instrumentation preferred.
• Experienced in testing inhalation dosage forms preferred.
• Bachelor’s degree in Chemistry, Chemical Engineering, or related preferred.
• Self-motivated with moderate supervision in a detail-oriented manner.

Job Type

• Full-time