Head of Sterile Product Development and CTM Manufacturing
Head of Sterile PD/CTM is responsible for leading a team of scientists and project leaders supporting R&D and GMP process development for clinical trial material (CTM) manufacturing of pharmaceutical parenteral, ophthalmic and other dosage forms.
Vice President, Biologics
Vice President, Biologics Services, will be responsible for the overall operations of the biologics department and reports to the EVP of Bioanalytical and Biologics Services in Frontage Laboratory, Inc. The VP will be responsible for the technical leadership, developing bioanalytical strategies, conversion of strategic visions into results meeting the revenue goal set by the management team and the quality and compliance requirements. The Director will also closely work with Frontage business development team providing with the technical supports, interacting with the clients on the scientific discussions, and presenting in the professional conferences.
Biologics Laboratory Directors and the Director of Project Management and Client Services for biologics.
Senior Clinical Project Manager
• A Bachelor’s or Master’s degree, preferably in a scientific discipline.
• A minimum of 5 years of clinical research experience in pharmaceutical companies and(or) contract research organizations, or equivalent education and experience.
• Thorough knowledge of FDA regulatory requirements is necessary.
• Experience managing or assisting in managing projects, in monitoring clinical studies, and in reporting project financial and overall project performance.
• Good communication skills with the ability to interact with all levels of management, sponsors and study site personnel.
• Proficient in Microsoft Office Applications.
The ideal candidate will have manufacturing and facility/equipment cleaning experience in a regulated pharma or biotech environment (GMP, SOPs, etc.).
Quality Assurance Manager, Clinical Services
Responsible to lead/execute the overall design, implementation and maintenance of a robust and effective Clinical Quality program to support Frontage and BDM clinic, data management and biometrics
Scientist, Bioanalytical Services
Scientist / Bioanalytical Services Essential Functions Run sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment.
Associate Director, Clinical Data Management
Build up the Data Management team; Ensure efficient DM processes and update/maintain SOPs; Manage and supervise DM personnels and ensure their career growth; Overseeing DM operation to ensure quality and timely delivery of DM services; Ensure effective communication with clients; Assist BD for DM related business development activities; Supervises: Data Management Associates, Coders and QC personnels
Associate Scientist, Vivarium
Highly motivated, time flexible, in vivo laboratory scientist to prepare for, schedule, and conduct discovery pharmacokinetic studies and mass balance studies. Catheter implant surgical skills to augment procedures in the collection of bio-fluid samples is desired. This person will prepare samples for analysis and subsequent reporting.This position will include some laboratory animal care and husbandry and some weekend and after hours time. Familiarity with Culex is a plus.
Analytical Services Metrologist
The Analytical Services Metrologist maintains and improves the HPLC and other instrument calibration, maintenance and documentation system consistent with all company and GMP compliance requirements.
Associate Scientist DMPK
Conduct rapid method development on LC/MS/MS – using any of the API4000, API5000 and API5500 mass spectrometers – for non-GLP quantitative assays Perform sample analyses for PK and in vitro metabolism studies Collate data from sample analyses and summarize in excel files for PK analyses Perform metabolism studies using radio-labeled compounds.
Associate Scientist, Analytical Services
Performs routine sample analysis and a variety of tasks to support product development, ensuring agreed timelines Assists method development
Business Development Director
The Business Development Director will work within a defined territory in pharmaceutical, biotech, and clinical research organizations to expand business with existing clients and establish business relationships with new clients. The Business Development Director will generate new business to expand our CMC, Bioanalytical, Clinical , and Biostatistics Services.
Clinical Research Nurse
Responsible for working under the guidance of Frontage Medical Director; Principal Investigator and Sub-Investigators; Clinical Operation Director, CRC Operations; and Clinical Research Coordinators to perform study procedures required in clinical research studies conducted on behalf of sponsors at Frontage Supervises: Laboratory Technicians and Medical Assistants (functional supervising responsibility).
Responsible for CRF designs, DMP and DVP write-up, and the generation and resolution of data queries. Work with database programmer to design database and edit check UAT. Training Data Management Assistants and Data Management Associates to generate data queries. Review and cleanup data.
Director, Clinical Data Management
Lead the Clinical Data Management (CDM) Department to ensure successful early phase CDM programs by maintaining superior personnel, systems, and processes.
The mission of the Safety Specialist is to provide expertise in safety and develop comprehensive safety services. The purpose of this role is to promote an overall safe workplace, and to create safety awareness throughout the organization.
Scientist, Sterile Product Development
The Scientist position is responsible for development and manufacturing of parenteral, ophthalmic and other sterile dosage forms. The individual will lead projects and act as a scientific project leader.
Senior Associate Scientist, Analytical Services
This position will mainly focus on supporting drug development, analytical research and developing activities, as well as cGMP testing
Senior Director, Business Development/ Early Stage Clinical
The Sr. Director, Business Development for Early Stage Clinical will work within a defined territory in pharmaceutical, biotech, and clinical research organization to expand business with existing clients and establish business relationships with new clients.
Senior Drug Metabolism Scientist
The Senior Metabolism Scientist position combines the knowledge of several scientific disciplines, such as biochemistry, drug metabolism/ pharmacokinetics, and analytical chemistry. Experience and knowledge of in vitro drug metabolism studies in support of drug discovery and development as well as the ability to perform in vitro and in vivo studies to address DMPK issues of candidate drugs is critical for this position.
Senior Scientist BioAnalytical Services
Senior Scientist / Bioanalytical Services Essential Functions Aid in the develSenior Scientist / Bioanalytical Services Essential Functions Aid in the development of bioanalytical methods. opment of bioanalytical methods.
Technical Writer/QC Specialist
The position is the technical writer and QC specialist. The main work for this position is to Prepare the data transfer result table;Review the result tables against data packages; write up the study protocols, reports, and methods.