Quality Assurance Manager

Reporting manager : Head of Quality Assurance

Job Location : New Jersey, USA

Minimum Qualification : PhD or MS in analytical or organic chemistry and 7+ years relevant experience preferably in analytical chemistry, API development and scale up/manufacturing, or at least 7+ years leadership position to enforce cGMP compliance and regulatory affairs

Job Summary :

Leadership responsibility to manage quality assurance and compliance programs and business excellence efforts at TCG GreenChem. Represent as in house worldwide expert in cGMP regulations and understanding phase appropriate development requirements in drug substance development process. Assist in overseeing practices assuring implementation and achievement of company strategic objectives with respect to the quality system. Take company responsibility and represent TCG GreenChem for all clients’ QA and regulatory requirements. Develop and implement quality management systems, which enable operational excellence.

Sr. Principal Scientist / Associate Director, Process Chemistry

Reporting manager : Vice President

Job Location : New Jersey, USA

Minimum Qualification : Ph.D. and 10+ years in industrial synthetic organic chemistry and process research and development

Job Summary :

A successful candidate will be joining a group of process chemistry scientists with broad deliverables, including designing and delivering manufacturing routes for drug candidates, driving innovative solutions to complex chemistry problems in the development phase and design and execute independent research that supports R&D projects. Implement new Development and/or technology goals and new experimental designs. Manage and prioritize projects within the laboratory. Implement and communicate tactics for achieving overall R&D project goals. Responsible for the management and development of scientific staff as applicable. A Ph.D. in organic chemistry with at least 10 years of experience in process chemistry is required. Candidates must possess a proven track record of solving complex synthetic problems, strong written and oral communication skills, and the ability to work effectively in a team environment.

Senior Scientist, Process Chemistry

Reporting manager : Director

Job Location : New Jersey, USA

Minimum Qualification : Ph.D. or 5+ years M.S. in Organic Chemistry

Job Summary :

A successful candidate will be joining a group of process chemistry scientists with broad deliverables ranging from the design of manufacturing routes for drug candidates to driving innovative solutions to complex chemistry problems in the development phase of small molecule pipeline. This position requires the design and execution of independent research that supports process R&D projects and goals. The Senior Scientist is primarily responsible for performing and managing scientific, technical, and technology activities, which may also include responsibility for the management of scientific staff on an as needed basis. A Ph.D. in chemistry with experience in synthetic methodology, total synthesis, or physical organic chemistry along with a proven track record of solving complex problems is required. Candidates must possess strong written and oral communication skills, and the ability to work effectively in a team environment.

Principal Scientist, Process Chemistry

Reporting manager : Director / Sr. Manager

Job Location : New Jersey, USA

Minimum Qualification : Ph.D. and 5+ years in industrial synthetic organic chemistry and process research and development

Job Summary :

A successful candidate will be joining a group of process chemistry scientists with broad deliverables, including designing and delivering manufacturing routes for drug candidates, driving innovative solutions to complex chemistry problems in the development phase and design and execute independent research that supports R&D projects. Implement new Development and/or technology goals and new experimental designs. Manage and prioritize projects within the laboratory. Implement and communicate tactics for achieving overall R&D project goals. Responsible for the management and development of scientific staff as applicable. A Ph.D. in organic chemistry with at least 4 years of experience in process chemistry is required. Candidates must possess a proven track record of solving complex synthetic problems, strong written and oral communication skills, and the ability to work effectively in a team environment.

Technician I / II (Kilo Lab)

Reporting manager : Kilo Lab Manager

Job Location : New Jersey, USA

Minimum Qualification : Bachelor’s degree in science or a related discipline with 1-2 years of experience preferred; Associate degree can be considered depending upon years of experience

Job Summary :

The basic purpose is to conduct technical activities according to protocols. Receives daily tasking assignments, under moderate supervision. Functions as a member of work team by assisting others and promoting a team-oriented work environment. Performs all work in conformance with applicable regulations. Performs all work in a safe manner. Works within the laboratory or processing environment

Associate Director, Process Chemistry Kilo Lab (PCKL)

Reporting manager : Chief Scientific Officer / Senior Manager

Job Location : New Jersey, USA

Minimum Qualification : Masters degree with 15+ years of industry experience or Ph.D. degree with 7+ years of process development, tech transfer to kilo lab and/or pilot plant experience

Job Summary :

Responsible for contributions to the scale up of APIs under non-GMP and cGMP manufacturing in the Process Chemistry Kilo Lab (PCKL).  This position requires responsibility of delivery of all required drug substance, of appropriate quality, to support development programs for pre-clinical studies including IND for Phase I up to Phase IIa clinical studies.  Overall responsibilities for the smooth and safe operations, and maintenances of the process development laboratories in TCG GreenChem.  Operate under cGMP guidelines in a highly compliant environment.  Responsible for establishing SOP’s, safety and compliance guidelines for process chemistry.  Introduce new and state of the art technologies and equipment to the kilo lab and tech transfer to the pilot plant.

Technician II

Reporting manager : Facilities / Technical Manager

Job Location : New Jersey, USA

Minimum Qualification : Associate’s Degree in relevant scientific/technical discipline and 0 - 2 years relevant experience or high school education (or equivalent) plus 3-4 years relevant experience.

Job Summary :

The basic purpose is to conduct technical activities according to protocols. Receives daily tasking assignments, under moderate supervision. Functions as a member of work team by assisting others and promoting a team-oriented work environment. Performs all work in conformance with applicable regulations. Performs all work in a safe manner. Works within the laboratory or processing environment.

Technician I

Reporting manager : Facilities / Technical Manager

Job Location : New Jersey, USA

Minimum Qualification : High school education or equivalent

Job Summary :

This position is considered an entry-level position for technicians. The basic purpose is to conduct technical activities according to operating procedures/protocols. Receives daily tasking assignments, under supervision. Functions as a member of work team by assisting others and promoting a team-oriented work environment. Performs all work in conformance with applicable regulations. Performs all work in a safe manner. Works within the laboratory or processing environment.

Project Manager, API for CDMO

Reporting manager : Sr. Management

Job Location : New Jersey

Minimum Qualification : Ph.D. or Master’s Degree with 5+ years of pharmaceutical industry experience or equivalent

Job Summary :

Plan, organize, and lead the time-critical project planning process in TCG GreenChem, Inc. for projects from Lead Optimization, Candidate Selection and IND enabling Preclinical Toxicity studies, to Phase I clinical supplies for API. Establish and maintain systems and business processes to track and report internal defined project objectives coupled with milestones for the TCG GreenChem portfolio consisting of US clients and international clients. Utilize these systems and business processes to routinely report time critical project planning activities for manufacture of API in a globally harmonized fashion in alliance with TCG Lifesciences in India in support of project-specific strategic decision making. Manage a business process platform to evaluate project planning scenarios, including milestone and deliverable dates, decision points and optimal balance of risks to meet short- and long-term development objectives across multiple projects.