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Recently in BioTech Pharma Jobs CategoryVerna Scientific: Senior Statistical Programmer III, Rahway, NJ Statistical Programmer - III (Senior) Rahway, NJ
A high level of proficiency with SAS's data step, macros, and various procedures is necessary along with excellent verbal and written communications. Familiarity with the clinical trials process is helpful. Relevant programming experience in SAS required. Experience with transforming data in various formats (excel, CSV, ASCII) into SAS datasets is important. Experience cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset is helpful. The incumbent may contribute to documentation. He/she should be prepared to present samples of past work that exhibit consistent, well-structured, mature and high quality SAS programming. He/she is expected to conform to SOPS and programming practices. FDA Looking For Experienced ScientistsThe Food and Drug Administration (FDA) has been under heavy fire in recent years for its approval of certain drugs and medical devices. The Vioxx scandal, in particular, rallied many legislators and consumer advocacy groups to demand changes within the organization. In response to this criticism, the FDA will be ramping up its safety operations and research. Mid-career scientists and pharmacologists may soon be able to parlay themselves into a comfortable position with the FDA. The agency has made plans to hire approximately 1,300 employees in an effort to increase drug and device safety. The FDA already employs 10,000 professionals. Says John Dyer, the FDA's deputy commissioner for operations, "It takes a large pool of talented people for the FDA to protect and promote the public health". The hiring is planned to take place within the next several months and the agency will be hosting job fairs around the United States. With 600 positions to be filled and 700 to be backfilled, those with adequate experience might be able to grab lucrative managerial positions. The FDA is primarily looking for biologists, chemists, medical officers, mathematical statisticians and investigators. If you are interested in sending your resume to the FDA, they are accepting queries at joinourteam@fda.hhs.gov. A schedule of job fairs can also be found here. This article is contributed by Heather Johnson, who regularly writes on the topic of career exploration. She invites your questions and writing job opportunities at her personal email address: heatherjohnson2323@gmail.com. Ropella & Associates: Purification Development Scientist Purification Development Scientist Ropella and Associates, the leading Executive Search Firm specializing in the Chemical and Allied Industries, has been retained to fill the position of a Purification Development Scientist for a cutting edge Biotechnology Firm. Project Assistants: Sr. Project Manager Assistant 6 month contract, Tarrytown, NY Sr. Project Manager Assistant Tarrytown, NJ We have an existing client (Biopharmaceutical industry) that is looking for us to assist them in supplying a Senior Project Manager to work onsite at their Tarrytown, NY location for a 6-month contract period of performance. Following is a summary of the position: General Scope of Work • Must have a general understanding of Project Management principles and can apply this knowledge to identify and resolve issues as they arise. • Problem Solving: They have the ability to provide guidance and advice on the needs of the project and set goals appropriately. • Knowledge: They have mastered several techniques and begin to demonstrate the ability to more quickly acquire and master new skills. • Typical activities involve meeting management, functional coordination, developing productivity or tracking tools, following up on action items. Job Description • Manages cross functional teams in a matrix organization in order to plan and execute the development strategy for a clinical development program. Cross functional areas include: clinical, regulatory, pre-clinical, manufacturing, research, patents, marketing, alliance management and finance, among others. • Coordinates the development, management and execution of drug development plans, timelines and budgets for assigned programs. • Together with the Team Leader, reviews the status of projects and budgets; Manages, schedules and prepares status reports and development plans for Sr. Management. • Liaises with respective functions responsible for the project and provides guidance on resolving project challenges by developing solutions to meet productivity and quality goals and objectives. • Develops tools and mechanisms for monitoring project progress for intervention and problem solving with project and line managers. • Coordinates the interactions b/w REGN and corporate partners for the development program if applicable • Ensures that all activities commissioned to the team comply with company standards, and US / EU Regulations (where applicable). Minimum Education Required: BS with a minimum of six years experience in Project Management, or an advanced degree with relevant Project Management work experience For consideration, please send a current resume with salary requirements and title of position of interest to, jgoodman@projectassistants.com. An equal opportunity employer, m/f/d/v. Please reference BioTechPharmJobs.com when responding. Red River Pharma LLC: Quality Control Analyst I, Shreveport, LA Supports the organization's mission, vision, and values by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect personalization, commitment to our community, and accountability and ownership. POSITION SUMMARY: The Quality Control Analyst I is a vital position in the Quality systems approach. The QC Analyst I will be responsible for chemical evaluation and testing of final product, intermediate products, stability samples and raw materials. Will assure ship schedules and contract testing requirements are met. PRINCIPLE DUTIES AND RESPONSIBILITIES: • Perform all chemical evaluation and testing of final product, intermediate products, stability samples and raw materials. • Performing QC assays. • Maintenance and calibration of all laboratory equipment. • Preparation of solutions and solvents as needed. • Responsible for monitoring and maintaining reagents needed for testing requirements. • Will be required to perform other duties as requested, directed or assigned. QUALIFICATIONS/SKILLS & KNOWLEDGE REQUIREMENTS • 0-3 years Pharmaceutical experience or related field. • BS degree in chemistry or a related field. • Has knowledge of commonly used practices and procedures within a particular field. • Computer skills proficient in use of e-mail, Access, Word, and Excel. • Experienced in the use of High Performance Liquid Chromatographs (HPLC), UV, Dissolution apparatus, IR, GC, wet chemistry, as well as microbiological testing are desirable. • Willing to learn and adapt to a changing environment, which may include new job assignments or special projects. • Oral and written communication skills, strong interpersonal skills, and superior organizational abilities. • Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment is essential. • Relies on instructions and pre-established guidelines to perform the functions of the job. GENERAL INFORMATION: The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required of personnel so classified. The incumbent must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and demands and to seek supervisory assistance as appropriate. Incumbents within this position may be required to assist or find appropriate assistance to make accommodations for disabled individuals in order to ensure access to the organization's services (may include: visitors, patients, employees, or others). Physical Demands: Regularly required to sit or stand, reach, bend and move about the production facility and lifting of moderately heavy items such as test equipment kits and product cases. Working around moving machines in production facility, and the handling and testing of food grade chemicals. Other physical demands include climbing, crouching, and reaching. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Personal Protective Equipment: • Respirator (Dust) Masks, Lab coats, gloves, sleeve protectors, steel toe shoes, etc. Work Environment: Work performed in an laboratory/office environment which involves moderate risks or discomforts that will require special safety precautions, e.g., working around moving machines in production facilities, handling and testing of food grade chemicals as well as hazardous materials (reagents used in the laboratory). The work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If you are interested in joining a team of professionals who are making a difference in the health of others, please contact Red River Pharma. Red River Pharma LLC offers a competitive compensation package and the satisfaction of belonging to a dynamic and vibrant health sciences organization. For consideration, please mail/fax your resume indicating position of interest, to: Red River Pharma LLC Attn: Human Resources PO Box 3723 Shreveport, LA 71133 Fax 318-678-8367 email: pnetherton@redriverpharma.com An equal opportunity employer, m/f/d/v. Please reference BioTechPharmJobs.com when responding. Makro Technologies: Process Development Scientist, Redwood City, CA Process Development Scientist - Protein Purification Urgent requirement for one of our top clients located in Redwood City, CA. Description: The position will require hands-on work developing downstream processes, tech transfer of processes to CMOs and on- site interactions and management of CMOs to facilitate scale-up and clinical/commercial production. The incumbent will be responsible for developing, scaling up, & improving downstream processes in collaboration with external parties and the internally with the Protein Analysis group. The position requires the ability to develop and optimize downstream processes in accordance with regulatory requirements and the company's timelines for Phase III/commercialization. The individual will also be responsible for identification and implementation of improved technologies for R&D and commercial manufacture to enhance product quality, manufacturing cost efficiencies & regulatory compliance. The position is likely to require the management and training of junior staff. Requirements: Ph.D in Biochemistry or Biochemical Engineering with emphasis on Protein Purification and 5+ years of experience; or MS in Biochemistry or Biochemical Engineering with emphasis on Protein Purification and 10 plus years of relevant industrial experience. Experience in optimization and scale up of protein refolding from E. coli is a plus. Prior experience with various PEGylation methods at small and large scale is preferred. Contact: The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. PDS_1508, to *** anitha.maturi@makrotech.com *** Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us. An equal opportunity employer, m/f/d/v. Please reference BioTechPharmJobs.com when responding. Makro Technologies: Quality Assurance Manager, Emeryville, CAQuality Assurance Manager Urgent requirement for one of our top clients located in Emeryville, CA. Description: Perform a variety of activities to ensure compliance with applicable regulatory requirements and facilitate the management of third-party contract manufacturing organizations. Participate in the design, establishment and maintenance of programs and processes that ensure quality products and compliance with current Good Manufacturing Practices (cGMPs) for pharmaceutical, biotech and drug/device combination products. Author, edit, review, and approve policies, SOPs, and guidance documents. Manage and administer processes within the company's Quality System. Collaborate with functional groups and contract manufacturers to evaluate and address complex issues such as deviations, technical complaints, corrective and preventive action (CAPA) and failure investigations. May lead or coordinate investigations and corrective and preventive action (CAPA) recommendations related to products. Lead or assist compliance audits (GMP, GLP, GCP, Internal and Supplier/External). Work with R&D as QA representative during new product start-ups, and identify routine checkpoints for new products and processes. Contribute to the completion of CMC sections of regulatory submissions. Provide Quality oversight for the labeling, packaging, storage, and distribution of clinical trial materials. Requirements: Bachelor's or Master's Degree in a relevant scientific discipline with 5+ years demonstrated QA experience in a pharmaceutical or biotech company. Prior compliance work with sterile product, aseptic manufacturing processes, or drug/device combination products is highly desirable. Must have an understanding and application of FDA regulations and guidances, QA principles, concepts, industry practices, and standards. Contact: The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. QAM_1508, to *** anitha.maturi@makrotech.com *** Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us. An equal opportunity employer, m/f/d/v. Please reference BioTechPharmJobs.com when responding. Makro Technologies: Manager of BDMP Quality and Training, Irvine, CAManager of BDMP, Quality and Training Urgent requirement for one of our top clients located in Irvine, CA. Position Description: Develops and trains to BDMP SOPs, WIMs, training material and other controlled documents. Applies regulatory ICH, GCP, and ISO quality system requirements to ensure appropriate SOPs, WIMs, and processes are in place and are adequately controlled and implemented within BDMP. Responsibilities are as follows: Participates in the development, training, and maintenance of BDMP controlled documents to ensure global adherence to Good Clinical Practices (GCPs) and related regulations and guidelines. Acts as liaison on teams with other departments, such as Clinical Quality and Training, Clinical Research, RDSIS, WWQA, and Global Regulatory Compliance. Supports ISO-13485:2003 Certification Activities, including complying with WWQA standards, training BDMP, coordinating all preparatory activities within BDMP, participating in the audit and response. Requirements: A BS/BA degree, or equivalent experience, in a science, math, or computer science discipline, with an additional 8 years experience in a relevant field; or an MS degree, or equivalent experience, with an additional 6 years experience. A minimum of 4 years of experience directly related to a BDMP-technical area, or 2 years of experience directly related to a BDMP-technical area and 2 years of BDMP or Clinical GCP training experience. Contact: The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. MBQT_1108, to *** anitha.maturi@makrotech.com *** Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us. An equal opportunity employer, m/f/d/v. Please reference BioTechPharmJobs.com when responding. Makro Technologies: Director of GCP Compliance, Seattle, WASenior Manager / Associate Director / Director of GCP Compliance Urgent requirement for one of our top clients located in Seattle, WA. Description: This position will be responsible for managing and maintaining the global GCP compliance program to ensure that clinical development is conducted in conformance with global regulatory requirements. This includes reviewing and auditing clinical operational systems (internal and external) impacted by European EMEA, ICH and US FDA regulations and extensive interaction and cooperation with clinical operations and regulatory functions to create a team approach to the evaluation. This position is also accountable for routine periodic reporting to management regarding audit findings and corrective action progress and the development and management of vendor qualification program including but not limited to pre-approval inspection readiness. This position will also manage GCP auditing staff. Requirement: Requires BS in Life Sciences or health related field or equivalent and 8+ years of applicable experience required with at least 5 years experience in global GCP compliance auditing in the pharmaceutical industry. At least 2+ years management of audit staff; global management experience is highly desired. Experience in clinical operational or clinical trial management environment is a plus. GCP compliance training experience is required. Contact: The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest and job No. SMGC_122907, to *** anitha.maturi@makrotech.com *** Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us. An equal opportunity employer, m/f/d/v. Please reference BioTechPharmJobs.com when responding. Makro Technologies: Clinical QA Auditor, Brisbane, CAClinical QA Auditor Urgent requirement for one of our top clients located in Brisbane, CA. Description: Plans and conducts GCP audits of Company's sponsored clinical trials, CROs, vendors, clinical laboratories, internal processes, databases and clinical study reports, as necessary. Provides assurance that clinical trials are conducted and that data generated and reported are in compliance with protocols, GCP, regulatory requirements through document reviews and audits. Conducts audits to evaluate internal processes related to conduct and reporting of clinical trials to assure compliance with study protocols, SOPs, GCPs, and regulatory requirements. Issues audit reports, recommends corrective action and may conduct follow up to audits and corrective actions. Provides timely written reports to inform management of Company's regulatory status based on audits of CROs, investigator sites and internal audits of Company's processes. May participate in the management of clinical trial product complaint system. Assists in performing GCP training for internal and external customers as needed. Assists in development of Clinical QA Standard Operating procedures, as required. Requirements: A BA/BS degree in the sciences, R.N. or equivalent experience. Minimum of 2 years experience in the Biopharmaceutical industry including at least 1 year experience auditing clinical sites and CROs, clinical laboratories, clinical study reports, or internal systems or at least one year experience as CRA. Demonstrates a thorough knowledge of GCP federal regulations and ICH guidelines and other regulations as applicable. Contact: The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. BD_122707, to *** anitha.maturi@makrotech.com *** Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us. An equal opportunity employer, m/f/d/v. Please reference BioTechPharmJobs.com when responding. |
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