(50025) Analytical Research and Development - Manager
3 weeks ago(4/30/2018 1:42 PM)
# of Openings
The Pharmaceutical Development Manager will oversee a project team of chemists in the laboratory conducting standard and advanced laboratory activities including stability testing of drug product and product characterization studies.
Supervise stability programs for regulatory submission, participating in laboratory activities as required
Plan laboratory activities on a weekly basis and ensure project timelines are met consistently
Develop and communicate project plans and goals to the group
Propose and implement processes and new technologies that lead to increased efficiencies and quality of laboratory activities. Drive the continuous improvement process.
Analyze data, identify trends and perform statistical analysis.
Write protocols, methods, standard operation procedures, and submission documents when required. Design experimental studies and write reports.
Provide expert support for analytical technical issues, analyzing data, identifying solutions, and implementing recommendations.
Independently develop statistical design of experiments.
Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers. Work and communicate effectively with other functional groups.
Ensure that members of the group are trained on relevant methods, policies and procedures. Verify that training records of group members are updated at least twice a year. Conduct performance reviews of group members and provide them with regular feedback. Support the personal development of group members.
Mentor and assist members of group
Immediately address any issues of non-GLP or GMP compliance as well as complacency regarding EHS policies and standards
Troubleshoot lab equipment issues or breakdowns
Conduct investigations of out of trend or out of specification results
Prepare documents such as methods, specifications, SOP’s, protocols and reports
Minimum Bachelor’s Degree in Chemistry or related discipline
3+ working in a supervisory role in the laboratory, specifically in Research and Development
12+ years working as an R&D Chemist for a pharmaceutical company
In-depth knowledge of pharmaceutical and inhalation technology
Knowledge of instrumental techniques such as HPLC, GC, IR, UV, and DSC, and other related analytical technologies and/or broad knowledge of development of MDI/DPI/Nasal products.
Knowledge of Regulatory requirements and experience in preparing regulatory submissions
Knowledge of GMP/ GLP. Good understanding of USP methodologies and ICH guidelines.
Above average written and verbal communication skills
Ability to establish and maintain working relationships with co-workers
Superior organizational, problem-solving and multitasking skills, with the ability to pick-up and learn new tasks quickly
Strong interpersonal skills; capability to work with a team as well as with a great deal of autonomy