Current Job Openings

Senior Scientist – Research and Development

The Senior Scientist will lead and assist with efforts in developing synthetic pathways and manufacturing processes toward new high value added pharmaceutical intermediates and bulk pharmaceutical drugs. This hands-on position will involve approximately 70% bench work with the remainder involved in results reporting, team collaboration, bench to pilot plant process technology transferal and pilot plant support work.

Accountabilities and Responsibilities

• Leading and Assisting with the development of synthetic pathways and manufacturing processes toward new high value added pharmaceutical intermediates and bulk pharmaceutical drugs
• Planning and executing laboratory research including kilo lab scale work
• Participate on cross functional project teams within Research and Development and across the Company
• Assume leadership roles for process development and plant support as needed and appropriate
• Utilizing professional concepts to contribute to the development of Company concepts and principles and to achieve objectives in a creative and effective manner

Requirements

• PhD in Organic Chemistry or similar with 5 or more years of industrial experience in multi-step organic synthesis and process implementation.
• Masters in Organic Chemistry or similar with 10 or more years of industrial experience and proven command of multi-step synthesis of small molecule APIs would be considered
• Operational knowledge of analytical instrumentation such as HPLC, GC, NMR required
• Strong command of chemical literature is required
• Good project management skills required
• Familiarity with high potency APIs and controlled substance handling a plus
• Familiarity with Empower a plus
• Experience in a manufacturing environment a plus
• Familiarity with compliance requirements within cGMP, safety and regulatory environments
• The ability to solve extremely complex problems where analysis of situations or data requires an evaluation of intangible variables
• Ability to work in a highly independent and self-directed work environment.

Research Scientist, Analytical R&D(Early Phase Pharmaceutical Small Molecules)

We are currently accepting resumes for the position of Research Scientist in Analytical R and D/Methods Development and Validation.

Responsibilities

• Must be fully capable of developing analytical methods based on experience, literature search, etc.
• Design, develop, conduct and/or review experiments including method development and method
• transfer; perform methods validations utilizing typical instrumentation including but not limited to LC,
• MS, GC, etc.
• Interpret data from routine and non-routine analyses in order to develop workable test methods
• and/or deduce and test mechanistic or systematic hypotheses;
• instrumental methods (wet chemical methods);
• Perform data audits in order to ensure accuracy of data and analytical processes;
• Act as scientific, regulatory, technical or quality expert and consultant by responding to targeted
• questions from and providing support to customers;
• Provide leadership including cross-training and technical development to the GMP Analytical laboratory colleagues;
• Organize workflow and tasks to maximize laboratory efficiency (e.g., prioritize sample analysis, manage/assign tasks, preventative maintenance);
• Maintain laboratory equipment and instrumentation (e.g., troubleshooting, conducting preventative maintenance, calibrating and repairing);
• Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review;
• Prepare samples for analysis and record data from analyses or experiments in a computer, log book, or laboratory notebook;

Quality Control Supervisor

Reporting to Quality Control Manager, the Quality Control Supervisor will supervise the day to day operation of the Quality Control lab, including scheduling of manpower resources and review and approval of product releases, employee training and testing support. Interaction with all areas of the manufacturing plant site will be inherent in this position.

Job Responsibilities

• Overseeing and coordinating daily prioritization of QC testing, including scheduling of staff and equipment and lab productivity assessments
• Participating on teams as the Quality Control liaison as required
• Direct supervision of laboratory staff including degreed chemists as well as additional laboratory support staff. Providing feedback and evaluations as needed and required.
• Approving or rejecting raw materials, in process and finished goods according to company and customer specifications
• Troubleshooting laboratory instrumentation issues
• Training laboratory employees as required. Monitoring training plan and matrix as required to ensure compliance and staff proficiency.
• Providing back up assistance in performing laboratory testing using HPLC, GC, Data Station, FT-IR, UV-vis, AA and computer analysis
• Assisting with management of critical laboratory programs such as stability program, reduced testing program, Environmental Services, retained samples, etc.

Job Qualifications

• BS in Chemistry
• 3 or more years of experience within quality control or a development laboratory. Experience in pharmaceuticals highly preferred and beneficial
• cGMP knowledge required
• Supervisory experience in a laboratory environment required
• Experience in a laboratory supporting manufacturing operations highly beneficial
• Knowledge in operation of general lab equipment as listed
• The ability to problem solve and prioritize daily/weekly needs to meet shipment schedules is essential. Ability to effectively multi-task essential
• Proficiency in a windows-based environment including word processing, spreadsheet and data base programs

Project Manager

Reporting to the Manager of New Products, the Project Manager will be responsible for overall project leadership for new product development opportunities.

Job Responsibilities

• Project specific P&L responsibility
• Lead and manage all aspects of project team including financials, timelines, sourcing, team dynamics and customer service
• Serve as liaison between Sales, Senior Management, and the project team for communicating expectations and delivering results
• Organize and coordinate multi-disciplinary teams for new product development initiatives
• Plan and effectively execute projects on time/on budget
• Evaluate new business opportunities, including detailed cost analysis
• Provide a high level of customer interaction
• Maintain a high level of positive and effective communication with customers, team members, management, and outside sales representatives

Job Qualifications

• A degree in Chemistry or Chemical Engineering, preferably an advanced degree, with 5 or more years of experience in a pharmaceutical arena, preferably with technology transfer experience
• Experience with overall management and responsibility for new product development project teams
• Familiarity with cGMP regulations
• Direct customer contact and relationship management
• Skills managing multi-disciplinary teams
• Understanding of business plans and financial impacts
• Good project management skills required. High attention to detail
• Windows based computer knowledge