Role Specific Requirements
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
- Author, review and execute to method transfer protocols for new product introduction and compendial validation
- Ability to work directly from the USP or EP pharmacopeia to write protocols and execute methods.
- Expertise with analytical tests utilizing HPLC/UPLC, GC, UV, IR, FTIR, KF and other laboratory instruments.
- Assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations.
- Assess analytical methods and perform gap analysis on analytical method validations for NPI. Develop plan and timelines for method transfers, required improvements and justification with approval from team to ensure compliance.
- Conducts complex analytical (physical & chemical) testing of raw materials, in-process samples, finished products required for method transfer and validation.
- Reviews laboratory documentation in notebooks, attachments, chromatography software and specification sheets for accuracy, completeness and compliance with established SOPs, specifications and methods.
- Conducts the investigation of deviations, out of specification (OOS), and non-conformances. Writes reports as required.
- Verifies and processes analytical data for method transfer. Writes technical documents such as methods, specifications, SOPs, method validation protocols and reports, method transfer protocols and reports.
- Participates in general lab duties, including clean up, administration, logbook review and operations support.
- Other duties as assigned.
Requirements for the Role
- 5-7 years in a Pharmaceutical Analytical testing lab & supporting stability programs
- B.Sc. in Chemistry, Biochemistry or related discipline
- Analytical Wet Chemistry Lab experience using the following methods/equipment: titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC assays
Competencies Required for the Role
- EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.
- EXECUTION/ACCOUNTABILITY – A willingness to accept responsibility or to account for one’s actions. Accountability is when an individual or a department experiences consequences for their performance or actions.
- CHANGE AGILITY/ADAPTABILITY – The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose, and embraces change. Strives for continuous improvement.
- ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
- THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
- DECISIVENESS – The ability to make difficult decisions in a timely manner and avoid procrastinating or asking for unnecessary data or information.