From resumes At workwondersstaffing.net Mon Jan 1 14:17:42 2007 From: resumes At workwondersstaffing.net (resumes@workwondersstaffing.net) Date: Mon Jan 1 14:14:49 2007 Subject: [Women-in-biology] [job] Regulatory Affairs Manager/Director - San Diego Message-ID: <025a01c72dd9$82892e50$0500a8c0@Mackenzie> [job] Regulatory Affairs Manager/Director - San Diego Our client in San Diego is looking for a Regulatory Affairs Manager / Director to join their team. Primary responsibilities will include developing and implementing strategies for the earliest possible approvals of regulatory submissions. This role will manage 510(k) submissions, international submissions and registrations. Duties will include approval of labeling and promotional materials, and writing and maintaining technical files. This role will be very involved with new product teams and will interact with product development, manufacturing and sales & marketing. The Regulatory Affairs Manager / Director will review product changes for regulatory impact, evaluate impact and analyze trends of government regulatory activities. Will interact extensively with FDA and other related agencies. This role requires a BA/BS degree in science, engineering, or medical technology. Requires at least 10 years experience in regulatory affairs. Required experience includes strong knowledge of FDA practices and requirements. Must be an expert data evaluator. Previous experience communicating directly with the FDA is a must. Requires experience in an FDA-regulated industry, preferably In-Vitro Diagnostics (IVD). The position requires excellent writing skills, strong presentation skills (oral and PowerPoint), great communication skills and strong teaming skills. Must have prior knowledge of clinical trials and involvement in clinical trials. Requires ISO 13485 experience. Proficient with Microsoft Office Suite (Word, PowerPoint, Excel, etc.) Apply: If you are interested in this position, please forward your Word formatted resume, cover note and salary requirement to resumes@workwondersstaffing.net. Please include the specific position to which you are applying in the subject line of your email. This will ensure your resume is routed to the correct recruiter as quickly as possible. From resumes At workwondersstaffing.net Mon Jan 1 14:23:43 2007 From: resumes At workwondersstaffing.net (resumes@workwondersstaffing.net) Date: Mon Jan 1 14:20:49 2007 Subject: [Women-in-biology] [job] Group Leader - Tarrytown, NY Message-ID: <029201c72dda$59c399a0$0500a8c0@Mackenzie> [job] Group Leader - Tarrytown, NY A client of ours in Tarrytown, NY is seeking a Group Leader cGMP Purification Responsibilities: The Principal Manufacturing Scientist / Group Leader will actively participate in and provide leadership to the manufacturing downstream processing group for the production of antibodies, therapeutic proteins and vaccines in compliance with current Good Manufacturing Practice (cGMP). The Scientist is responsible for the planning and execution of cGMP protein purification, and for the transfer of manufacturing process from Manufacturing Sciences to GMP Manufacturing. They also play a key role in improvement of downstream processing operations to enhance efficiency and quality. a.. Plan, execute and follow up on all aspects of the downstream processing in compliance with cGMP. b.. Coordinate downstream processing activities with Quality Assurance, Quality Control, Operations, Manufacturing Sciences, and upstream processing of Manufacturing. c.. Write and review cGMP documents including standard operating procedures and manufacturing batch records for the downstream processing area. d.. Transfer and scale up purification process from Manufacturing Sciences to GMP Manufacturing. e.. Hire and train downstream processing staff and manage the performance of the group. Proactively seek improvement in the downstream processing area. f.. Hire and train downstream processing staff and manage the performance of the group. Requirements: Requires a BS Degree with 7-10 years experience in pharmaceutical manufacturing. Technical experience with protein & antibody purification; equipment engineering specialist; biochemistry, biochemical analysis and scale up. Apply: If you are interested in this position, please forward your Word formatted resume, cover note and salary requirement to resumes@workwondersstaffing.net. Please include the specific position to which you are applying in the subject line of your email. This will ensure your resume is routed to the correct recruiter as quickly as possible. From resumes At workwondersstaffing.net Tue Jan 2 10:56:27 2007 From: resumes At workwondersstaffing.net (resumes@workwondersstaffing.net) Date: Tue Jan 2 10:53:33 2007 Subject: [Women-in-biology] Chemist II - Kalamazoo, MI Message-ID: <05a101c72e86$8fbc0db0$0500a8c0@Mackenzie> Chemist II - Kalamazoo, MI I am recruiting a Chemist II for a research laboratory located in Kalamazoo, Michigan. Here are the job details and information about the company: The company has openings for chemists (and related disciplines) with a strong interest in analytical chemistry to develop, implement, and perform new analytical methods for the measurement and quantitation of new pharmaceuticals in biological matrices and product dosage forms. Methodologies employed include HPLC utilizing both Fluorescence and UV Detection, Dissolution Testing, Immunoassays, Small Molecule X-ray Crystallography, Radioanalysis (sample oxidation and liquid scintillation analysis), GC, MS/GC, and LC/MS/MS. Candidates should have a background in analytical chemistry or related disciplines; good communication, laboratory, and computer skills; and the desire to work in a dynamic and intellectually challenging environment. They are a rapidly growing organization where your contributions can make a difference. Company: They believe that great people make a great company and work hard to offer an environment that encourages team spirit and fosters personal growth. They recognize that employees are people first and accommodate personal lives and families. They strive to create an environment where every person can achieve their fullest success and make every effort to make your job more fun and less work. Some of the ways this is accomplished is by having a casual dress code, flexible hours, and a comfortable, well designed work environment. In addition to an excellent environment, the company believes that all employees should share in the good fortune of the company. Therefore, they have an excellent benefit plans and profit sharing. If you are interested in pursuing this opportunity, please provide the following: 1) resume in word or txt format 2) salary requirement 3) work authorization - i.e. green card holder, citizen, etc 4) relocation considerations (if any) From resumes At workwondersstaffing.net Wed Jan 3 16:30:11 2007 From: resumes At workwondersstaffing.net (resumes@workwondersstaffing.net) Date: Wed Jan 3 16:27:21 2007 Subject: [Women-in-biology] QA Manager - Lansing, MI Message-ID: <050001c72f7e$599d3c10$0500a8c0@Mackenzie> QA Manager - Lansing, MI I am recruiting a QA Manager for a biopharmaceutical company's Lansing, Michigan division. Here are the details: Job Description: The ideal candidate for this position will have QA signing authority and responsibility for representing QA on a wide spectrum of projects that require QA oversite and input. This individual will be responsible for day-to-day functions and will also serve a great deal of time in a project capacity. Although not directly responsible as project manager of each associated project, this person must possess strong leadership skills and the ability to be the primary QA resource for those projects. This position will not have any direct supervision of employees, although resources may be allocated for management and direction in order to support projects. As this person will have multiple competing priorities, ideal candidates must not only have strong leadership skills but must also possess an attention to detail and be an excellent communicator. There is also a need to be able to transfer Phase 3 clinical knowledge to support on-going projects and provide key QA support. This individual will report directly to the Director, Quality Assurance. Will interface with day-to-day operations of many departments, including QA and Project Management. Requires: Travel may be required periodically, however, the position will be based in Lansing, Michigan. BS in a Biological Science or related field. 10+ years of direct QA experience in a GMP biopharmaceutical environment, including validation, and working within an electronic document management system. Special Skills Required: Walking and climbing stairs. Lifting up to 25 lbs. Must possess exceptional interpersonal skills in addition to solid verbal and written communication skills. Must possess exemplary leadership skills and knowledge of project management tools. Must be a self-starter and able to manage and excel in a fast paced environment with multiple priorities. Direct knowledge and experience in the transfer of Phase 3 clinical knowledge is required. If you are interested in pursuing the opportunity, please forward the following to resumes@workwondersstaffing.net: 1. Resume 2. Work Authorization 3. Salary Requirement 4. Relocation Considerations (if any).