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 through the 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 the sharing of resources, on-time delivery of results, and 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 the Supervisor or Manager.
Qualifications and Skills
- 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. 5-8 years of analytical/research laboratory experience required, preferably in a generic pharmaceutical.
- 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 the ability to multitask are essential for success.
- Balance time between work in compliance, testing, and teaching and supervision of analysts.
- The ability to multitask and an aptitude to learn are essential to success in this position.
Physical Demands & Work Environment:
- 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.
Work in a highly collaborative and motivated working environment
Participate in a comprehensive benefits package, including Health, Dental, Vision, Life Insurance, Short-term/Long Term Disability and participate in matching 401(k) plans