Senior Chemist at Alcami in Morrisville, NC

Responsible for providing technical and scientific support in developing, validating and executing analytical testing at TriPharm Services, Inc. Position will collaborate with cross-functional teams and will work side-by-side with other scientists and professionals to drive the scientific agenda.

Essential Functions

• Take a central role in development, validation and testing of small molecules in pharmaceutical products.
• Assist in the boarding of the state-of-the-art technologies and instrumentation.
• Write and review method validation protocols, reports, SOPs, investigations, test methods and specifications.
• Coordinate progress of root cause identification, deviations, change controls, corrective and preventive actions (CAPA).
• Lead commissioning activities and set up of safety programs for the laboratory space.
• Lead the initiative of integration and automation of processes to ensure integrity of laboratory data.
• Act as a Subject Matter Expert (SME) concerning various laboratory software usages (Empower3, ProCal, Master Control, ELN, etc.).
• Lead development of testing templates in Laboratory Information Management System.
• Ensure all equipment is properly calibrated and serviced to support high throughput and full compliance.
• Assist in designing of monitoring and testing programs and strategically evaluates processes for improvements and optimization.
• Identify and lead improvements opportunities to enhance LEAN culture and infrastructure.
• Track and review the project progress to achieve operational goals and metrics.
• Develop team members by adequate training, mentoring and motivation, as well as adherence to quality performance standards.
• Actively participate in cGMP inspections, client visits and regulatory audits.
• Perform additional duties as required.

Education and Experience

• Bachelor's degree in degree in Chemistry or Pharmaceutical Sciences with 6 years related experience, or equivalent education, experience and training; Master's degree with 4 years related experience; Doctorate Degree with 2 years related experience knowledge.
• Proficiency in small molecule testing using HPLC/UPLC, GC, particle size analyzer, dissolution, wet chemistry and other testing methods in a cGMP environment.
• Knowledge of USP, Ph.Eur., FDA, and ICH requirements as they apply to production and testing of drug substances and drug products is a must.
• Experience with inspections/audits by regulatory agencies and clients.
• Ability to find a solution for or to deal proactively with work-related problems; ability to look beyond the standard solutions.

Alcami Non-Negotiables

• Consistently demonstrates honesty and integrity through personal example.
• Follows all safety policies and leads by example a safety-first culture.
• Produces high quality work product with a focus on first time right.
• Complies with the company code of conduct and policies and regulatory standards.