new jobs posted at transgenics.com
some big ones. I'm pretty sure the director of clinical affairs position is new:
Director: Clinical Affairs
Purpose:
To direct and manage the planning and implementation of all clinical affairs activities domestic and global, as required, in collaboration with the director of clinical affairs and senior management. Develops and implements strategies for clinical research conducted primarily through CROs and manages interpretation of results in preparation for regulatory submissions. Oversee all administrative aspects of clinical programs (e.g., budgets, CDAs, contracts, CRO / contractor relationships, insurance, clinical investigator relationships).
Responsibilities:
* Develop long and short term planning strategies
* Supervise all clinical affairs activities
* Monitor all projects and program costs
* Develop and support new project areas as required
* Allocate study team (CRO/Contractors/internal staff) for the projects
* Interact with senior management & key functional groups about issues affecting the timelines
* Establish & maintain Clinical Development Plan and timelines
* Collaborate with senior management on relevant long-term plans & track project progress in meeting key milestones
In addition, the director will:
* Ensure that the clinical trails are conducted in accordance with the Good Clinical Practice Guidelines (GCPs), International Conference on Harmonization (ICH), and GTC's Standard Operating Procedures (SOPs).
* Manage development of required clinical related SOPs in conjunction with quality and regulatory
* As necessary, train & supervise the CRAs/clinical monitoring team/staff to ensure adherence to CFR, GCP and SOPs.
* Draft & finalize scientifically sound protocols
* Oversee & direct the development of the Case Report Form, Investigator Manual, Monitoring Reports
* Tracking of patient accrual, CA & Ethics committee submissions
* Collect required documents to support regulatory requirements
* Maintain updated Investigator's Brochures
* Ensure that Clinical Medical Files are in accordance with the FCR, GCPs & SOPs
* Select qualified investigators for participation in trials managed by GTC
* Actively participate and contribute to publication/manuscript endeavors
* Manage & direct the preparation of any Legal Document requirements; (e.g., Power of Attorney, Indemnification Statements, country specific Insurance policies).
* Prepare clinical sections of required regulatory documents, including IND or IDE flings, safety reports, annual reports, final study reports, and NDA/PLA/MPA filings
* Collaborate in developing written materials to support sales and marketing efforts (e.g., papers, product inserts, presentations, etc.).
Requirements:
Minimum BS/RN; 10 years experience in pharmaceutical/biotech industry.
Manufacturing Manager (Framingham and Charlton, MA)
Responsible for managing the day to day operation of the GTC production Source Material (SM) Collection Parlors, Initial Processing Facility (IPF) and Purification Suite. Ensures suitability of daily task assignment plans related to projects as well as facility operation. Works with Technical Operations, Process and Analytical Development (PAD), and Quality staffs to resolve technical and documentation issues, ensuring compliance with all applicable regulations (FDA, DEP, OSHA, etc.). Ensures the effective use of material, facilities, and personnel in producing quality products. Work requires ability to switch back and forth from development to clinical production modes of operation. An understanding of processing active biological molecules, such as proteins, is key. Emphasis is placed on working with other departments in a team to accomplish the developmental objectives.
* In collaboration with Tech Ops and PAD, transfers processes into a preclinical and clinical production environment.
* Provides Production Planning and Purchasing with timely information regarding material needs.
* Contributes to the development of and is responsible for the daily operation and documentation (SOPs, Batch Records, training records, etc.) of the SM Collection Parlors, IPF, and Purification Suite systems at GTC.
* Responsible for ensuring those individuals working in the SM Collection Parlors, IPF, and Purification Suite are trained to perform their assigned tasks and that training records are up to date and accurate.
* Reviews Non-conformance Reports for causality and designs and implements corrective action plans (in conjunction with Quality). Proactively seeks opportunities to improve facility, equipment and practices.
* Contributes to the budget process, identifying capital equipment and labor resources required to accomplish company and departmental goals.
* Coordinates with other Supervisors and Managers to ensure consistency across departments in terms of personnel policy and regulatory compliance enforcement.
* Responsible for responding to queries by representatives of the regulatory agencies or customers during regulatory inspections or client audits.
* Responsible for maintaining awareness and proficiency in contemporary good management practices, including ensuring leadership training and succession planning among the staff.
* Coordinates with Facilities to ensure scheduled maintenance and repairs are completed and properly documented.
Requires at least ten years experience in biopharmaceutical process development/clinical and/or commercial manufacture environment. Must work well with others in a team-oriented, matrix-management, rapidly changing environment and have people and project management experience. Understanding of basic business principles and practices. Must be able to clearly and timely communicate pertinent information in both written and verbal form to peers, supervisors, subordinates and other departments. Bachelor's degree in biology or chemistry (or related field); Master's degree preferred. Flexibility required to periodically work beyond standard scheduled hours.
QC Analyst I
Performs general laboratory procedures in support of microbiological testing of in-process and facility monitoring samples. Brings issues to the attention of the lab supervisor and assists in the resolution. Follows assigned work plans with general supervision. Performs microbiology and environmental monitoring testing methods such as viable air monitoring, surface sampling, bioburden testing and endotoxin analysis. Responsible for data tracking, analysis and reporting using MS Word, MS Access and Excel software. Good interpersonal, communication, organizational and problem solving skills required.
The position requires a Bachelor’s degree in Microbiology/Biology or related field with 0-2 years experience. Must be able to follow oral and written procedures accurately and should be familiar with basic laboratory aseptic techniques. Microbial Identification experience preferred. Strong interpersonal communications, organizational and problem solving skills needed as well as a successful demonstration of working independently and as part of a team.
Compliance Specialist
Through audits and daily interactions with the Operations, QC, Development, Analytical and Veterinary Services staffs, it is the responsibility of this position to monitor and evaluate the company's compliance with GTC's Standard Operation Procedures, the quality program, policies, and regulatory documentation. When deficiencies or deviations are noted, recommendations for compliance are made. This position will also be responsible for data collection, trending and analysis reporting. This position will be in Framingham, with travel to Charlton facility as necessary. (up to 50%)
* Maintains up-to-date working knowledge of national and international standards and guidelines; especially how they relate to the practical implementation and compliance with Quality Systems.
* QA oversight for External Programs
* Animal Qualification Program
* Incoming Inspection of Raw Materials at Farm & Framingham
* Participate in Internal Audits
* Maintain the following Quality Systems: Database maintenance, Coordination of system evaluations and impact assessments, scheduling meetings for follow-up closure, printing monthly trending reports.
* CAPA
* Deviations
* Change Control
* Batch Record reviews and compliance review of External programs as well as QC data, PM records, water system, EM, cleaning logs, etc.
* Review of new equipment characterization forms, OOTs, and other equipment-related data.
* Utility / Facility Validation reviews and IQ/OQ reviews for QC Equipment
* Data Control - maintain control of files in QAD pertaining to Manufacturing
* Conduct Quality System Training as needed
* SOP Reviews and Approvals; and write new QA procedures as needed
Other Duties as Required
Requires a Bachelor's degree with at least 3-5 years of experience working in a quality assurance department for an FDA/EMEA regulated company. Complete understanding of documentation and data requirements for GMP operations. Must be able to communicate effectively with multiple disciplines. Minimum of 2 years record review, lot release and auditing experience.
Process Development Scientist
Responsible for developing robust/scaleable protein clarification/purification processes for GTC’s therapeutic protein products. Conduct various bench scale process development experiments. Identify critical process parameters and establish operating ranges for optimum recovery/yield. Participate in scale-up of developed processes to pre-clinical, clinical and commercial scale with consideration towards process efficiencies and costs projected for full scale operation. Familiarity with typical analytical methods used for evaluating proteins. Experience in a GMP environment regarding CMC activities. UF/DF, filtration, viral clearance, process chromatography, TFF, DFF, centrifugation, HPTFF, fractionation understanding is necessary.
This position requires a degree in Chemical Engineering or relevant engineering discipline with broad knowledge and application of basic theories, principles and techniques in bioprocess engineering. Experience working with recombinant proteins and analytical techniques related to area of expertise, such as cell culture, separation sciences, pharmaceutical development, biochemistry, or analytical chemistry is preferred. Strong interpersonal communications, organizational and problem solving skills needed as well as a successful demonstration of working independently and as part of a team.
Associate Director/Director Formulation and Analytical Development
Responsible for protein formulation development and analytical development activities in support of GTC pre-clinical and clinical programs. Conduct pre-formulation experiments (e.g., pH-stability, pH-solubility) on protein candidates to characterize strengths and weaknesses and devise appropriate formulation strategies. Develop injectable (liquid/lyophilized) pre-clinical formulations of various protein Biotherapeutics to support pharmacokinetics, efficacy studies and toxicology.
A degree in Pharmaceutical Sciences, Biochemistry is required. PhD and five years experience or MS and 10 years experience is required in protein formulation and protein analytical development. Familiarity with FDA requirements, ICH guidelines and GMP guidelines.
Scientist, Formulation and Analytical Development
Responsible for conducting studies in support of protein formulation development and analytical development activities. Conduct pre-formulation experiments (e.g., pH-stability, pH-solubility) on protein candidates to characterize strengths and weaknesses and devise appropriate formulation strategies. Perform laboratory studies on candidate injectable protein formulations (liquid/lyophilized) to identify pre-clinical formulations to support pharmacokinetics, efficacy studies, and toxicology. Perform studies on candidate formulations to support clinical tries. Familiarity with typical analytical methods used for evaluating proteins. Familiarity and experience in a GMP environment regarding CMC activities.
MS/BS in Biochemistry is required along with 3 – 5 years experience in protein formulation or protein analytical development.
Process Development Associate
Responsible for performing a variety of basic laboratory procedures related to process and analytical development for GTC’s recombinant proteins. Perform various bench scale process development procedures including buffer preparation, clarification of transgenic milk by centrifugation, and concentration/diafiltration of protein solutions. Perform various analytical procedures needed to support process development activities. This includes SDS-PAGE and western blotting. Participate in scale-up of developed processes and transfer to manufacturing or QC. Familiarity with basic laboratory procedures, including centrifugation and filtration. Familiarity with procedures related to protein purification and characterization (chromatography, electrophoresis) is a plus. Strong interpersonal communications, organizational and problem solving skills needed as well as a successful demonstration of working independently and as part of a team.
This position requires a degree in biology or chemistry with 0-2 years experience. Experience working with basic protein purification and characterization techniques is preferred.
Regulatory Affairs Manager
Responsible for long- and short-term planning and directing of Chemistry Manufacturing Control (CMC) regulatory activities. Interprets corporate policy, develops and implements strategies for the earliest possible approval of regulatory submission, advises and manages the regulatory teams, and reviews ongoing projects. Plans, schedules and directs activities and programs through regulatory staff. Negotiates with outside agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of product and services. Reviews and prepares responses to inquires from regulatory authorities relating to product registrations. Monitors and updates national and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel. Communicates pertinent changes and updates to regulatory staff and senior management. Oversees the preparation and submission of applications and routine reports/renewals, including the preparation and submission of supplements and amendments as required by internal department (Manufacturing, QA/QC, Medical, etc.) to update registered product information. Provides input on budget requirements, and monitors project and program costs.
This position requires a BS/MS in a scientific field and 8 years experience.
Regulatory Affairs Specialist
Ensures all company products meet worldwide regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/ interpretations. This may include the review, evaluation, and compilation of files and reports for submissions. Provides project team representation and direction in managing information from/to other departments (including R&D, Manufacturing, Quality Assurance, Quality Control, Medical Affairs, Marketing, and Clinical Affairs) regarding Regulatory submissions. This may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments. Reviews technical and clinical documentation and recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Is responsible for the timely completion of regulatory projects and submission of documentation to regulatory agencies. Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes. Responsible for corporate archive of assets. Maintain FDA and EU correspondence
This position requires a degree in biology or chemistry with 4 years related experience. Candidate must be proficient in MS office products. Strong interpersonal communications, organizational and problem solving skills needed as well as a successful demonstration of working independently and as part of a team.
GTC Biotherapeutics, a dynamic biotechnology company with headquarters in Framingham, Massachusetts, is the industry leader in the production of therapeutic proteins in the milk of transgenic animals. GTC Biotherapeutics is an Equal Opportunity Employer, and offers a comprehensive benefits package, including health, dental, and life insurance, three weeks' vacation, company stock options, tuition reimbursement, an employee stock purchase plan and a 401(k) investment plan.
Interested candidates should mail or fax resume to GTC Human Resources, 175 Crossing Blvd. Framingham, MA 01702; Fax: 508-370-5291, or e-mail resume to gtc-hr@gtc-bio.com.
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