Supervise study statistician in implementation and execution of methodological and
statistical aspects of clinical studies. Manage biostatistical activities related to drug product development for assigned clinical studies. Collaborate with study team internally and with clients of BDM Consulting, manage study timeline, and ensure the quality of the statistical analysis output.
POSITION TITLE: RECEPTIONIST/RECRUITER
Reports to: Recruiting Supervisor
Duties: Responsible for serving as the receptionist of the Clinical Research Center. In addition to working as the receptionist for the Frontage CRC, maintain an organized office environment in the day-to-day operation of the Frontage Clinical Research Center (CRC).
Qualifications: High School Diploma, Associate’s degree is preferred.
Job Title: Chemist/Scientist
Job Location: Exton, PA 19341
Job Duties: To develop, validate, and transfer analytical methods and analyze pharmaceutical samples. Perform chemical testing following stability protocols and approved methods, and participate in instrument qualification. Perform analytical method transfer, optimization, development, and conducts analytical methods validation of drug substances, drug product, and residual testing, using guidelines from United States Pharmacopeia (USP) and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Author test methods, protocol and reports. Provide analytical testing support for manufacturing process validation, as well astroubleshooting assistance to internal manufacture teams and external clients. Perform routine sample processing and dosage form analysis using HPLC, GC, UV-Vis and other applicable analytical instrumentation. Collate test results and prepare certificates of analysis and stability reports. Comply with all relevant current Good Manufacturing Practices (cGMP) and/or Good Laboratory Practices (GLP) regulatory requirements while carrying out assigned studies.
Requirements: MS degree in Chemistry, Chemical and Biomolecular Engineering, or
relevant scientific discipline; proficiency in operating analytical technologies including Gas Chromatography/Mass Spectroscopy (GC-MS), Fourier Transform Infrared Spectroscopy (FTIR).
To apply: Send CV to HR of Frontage Laboratories, Inc., 700 Pennsylvania Drive, Exton PA 19341. Ref. JCPA2017
The ideal candidate will have experience in handling biological samples, chemicals, sample logistics and sample tracking, experience in regulated environments (GLP, SOPs, etc..), and strong written and oral communication skills.
Head of Sterile Product Development and CTM Manufacturing-CMC
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 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-CMC
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-CMC
Performs routine sample analysis and a variety of tasks to support product development, ensuring agreed timelines Assists method development
Business Development Director-West Coast
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).
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-CMC
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-CMC
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.