RA Technical Systems Analyst
Talascend is currently seeking an RA Technical Systems Analyst for a direct hire opportunity in Houston, TX.
This Houston based company provides mid-stream energy logistics services. This company owns and operated one of the nation's largest independent petroleum products. They are looking to bring on an RA Technical Systems Analyst to join the team. If you are looking for a dynamic and growing company then this could be your next opportunity.
The purpose of the role of RA Technical Systems Analyst is to enhance the success of SolArc Right Angle users and provide technical services to the Business Team. More specifically, an individual in the role will add their unique mixture of problem solving skills and broad based business, technical and Right Angle knowledge to successfully support and maintain the SolArc Right Angle and other production environments.
Key Accountabilities:
- Serve as Internal SolArc Right Angle Administrator
- Ensure proper administration and setup of SolArc software offerings
- Administer SolArc Right Angle security and perform analyses
- Understand and apply SQL and PowerBuilder programming skills to support the applications
- Coordinate with the Applications and Operations Service Delivery team regarding server, database and patch administration
- Assist in writing reports / provisions / other technical extensions within RightAngle
- Create documentation and supporting materials when needed
- Monitor and ensure proper usage of SolArc RightAngle by end users
- Help users become self-sufficient by mentoring and addressing their issues
- Log issues received from users on the SharePoint site
- Investigate and analyze issues received from the Right Angle users
- Use SQL and Right Angle knowledge to investigate issues
- Liaise with Business Contacts to prioritize issues and communicate progress
- When applicable log issues with SolArc using RAID online
- Maintain customer status on all RAID issues
- Work with SolArc to facilitate issue resolution including any database logistics and recreation needs
- Prioritization of issues using tools on mysolarc.com
- Communicate with SolArc Account Owner to resolve issues that will include sending all requested information and answer questions on issues. (This will probably require collaboration with specific power users and general user community)
- Mange the need for user availability for detailed questions/meetings around specific issues
- Participate in special projects as needed
Organic Synthesis Chemist
Kelly Scientific Resources is currently searching for an Organic Synthesis Chemist for a specialty chemical company in Houston Texas. Qualified candidates will have a degree in Chemistry with 10 years of industry experience with product development, optimization, scale up, and commercialization. Experience with analytical techniques including GC and GPC is also required. Candidates with experience with elastomer chemistry are highly preferred. If you meet the above qualifications and would like to make an impact within a small growing company, please submit your resume for consideration.
Kelly Scientific Resources is recognized as the world leader in the scientific staffing industry. Our recruiters are scientists themselves with prior industry experience. We offer a competitive benefit package including access to individual health plans and a retirement savings program. We provide scientific staffing services on a temporary, temp to hire, and full-time basis to a broad spectrum of industries including Chemical, Environmental, Food Science, Oil and Gas, Pharmaceutical, and Biotechnology.
Please visit us at http://www.kellyscientific.com to learn more.
Kelly Services is an Equal Opportunity Employer.
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.
Associate Sample Coordinator
Associate Sample Coordinator- R&D Labs
This is a Temporary role in Northern KY. Must be open to 1st or 2nd shift.
• Performing duties and training to acquire the skills required for sample and standard handling in support of the laboratory.
• Providing support to Sample Coordinator and performs administrative tasks in the Sample Management Department.
• Following SOPs, applicable client procedures, and fulfilling laboratory requests with modest direct supervision.
• Punctuality and dependability are very important.
Job Duties will include:
- Unbox/receive large sample shipments
- Check sample information from printed shipment manifest to IT system/sample vial
- Receive samples into IT system
- Assign storage locations in IT system
- Place samples in -70C storage units
Qualifications
Education and Experience:
• Associates Degree/Certification/Diploma in a laboratory science, or a B.S. / BSc / B.A. degree with no previous industry experience.
Or
• Non-degreed (High School or equivalent) with a minimum of 2 years experience with inventory handling/tracking or in a laboratory setting.
Knowledge, Skills and Abilities:
- Ability to read, identify, transcribe, and communicate details accurately
- Ability to perform daily work assignments accurately, timely and in a safe manner with moderate supervision
- High attention to detail
- Basic computer skills (email, word processing, navigation)
- Ability to communicate sample/standard status to supervisor and laboratory staff
- Manage time effectively to complete assignments in expected time frame
- Maintain sample/standard tracking and complete all required documentation and tracking clearly and accurately according to SOP
- Ability to communicate effectively and follow detailed written and verbal instruction
- Cooperate with coworkers with an organized team environment or work alone with moderate supervision
- Ability to train on SOPs, regulatory guidelines, and storage requirements
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.
Biologics Center RA Interface Head
Department: Global Regulatory Affairs
Interest: Regulatory Affairs
Job Summary:
The Interface Head is accountable and responsible for providing dedicated, long range and high level strategic Regulatory guidance (regulatory strategy) to the Global Biotherapeutic Center. Global regulatory strategies are required for all phases of Biologics R&D from disovery lead generation up to and including marketing application for internal and externally licensed projects. The incumbent is accountable and responsible for ensuring that the provision and execution of the Regulatory R&D strategy, meets the priorities, timelines and excellent quality expected by the Global Biotherapeutic Center for complex global biologics dossiers. This accountability and responsibility requires Biologics project assignment, strategic overview and issue resolution, for 10 + globally based regulatory associates performing regulatory functions for Global Biotherapeuitc Center projects across all business divisions (BDs) therepeutic areas (TSU) and DPUs. Since the incumbent has a wide span of control, project oversight is also accomplished through long range planning, strategic leadership, and negotiation through all levels of R&D, IA, including Sanofi-Chemie, Q and C, external partner companies and Regulatory Agencies as necessary. The incumbent works collaboratively to represent Regulatory R&D with one voice at Global Biotherapeutic Management meetings,, other Senior Leadership Meetings, Regulatory Biologics Health Authority Meetings and cross functional internal and external partner Project Teams across R&D , and IA. The Interface Head provides a vision and leadership for the Regulatory Policy Program in order to develop s-a representation in external activities. The incumbent leads the cross functional Community of Practice for Biologics which creates, establishes, mentors trains and maintains a high level of Biologics regulatory expertise among associates in Global Regulatory Affairs, Global Biotherapeutics, IA and LG-CMC. The Interface Head demonstrates behaviors that live and promote the s-a values.
Major Duties & Responsibilities:
Lead and direct long range and high level strategic guidance to Global Biotherapeutics. Strategies should be reasonable, cost effective and scientifically sound. This is essential for Global Biotherapeuticsa to effectively, rapidly and successfully bring projects into the clinic and on to marketing approval. Specialized education and experience is required to achieve this responsibility. Responsible for design of global regulatory strategies for all Biologics Projects from lead generation through marketing application. The projects include complex products ranging from Monoclonal Antibodies, to Antibody Drug Conjugates, stem cells and nucleic acids. Demonstrates very strong strategic leadership skills, communication skills at all levels, influencing and negotiating skills including coflict management resolution. Capable of resolving and or advising on very complex biologics technical issues. Globally accountable to assure common understanding and consistent strategy throughout s-a R&D as well as IA and external partner companies.
Accountable and responsible to assure that Regulatory R&D strategy, provided to Global Biotherapeutics, fully meet the priorities, timelines and quality expected by them for complex global biological dossiers at all stages of development. Accountable and responsible for all strategic and some tactical activities across all units of Regulatory R&D including project assignment, project strategic overview/validation, major issue resolution of Biologics dossiers from 10 + Biologics specialists. Assures that, for major activities with a critical regulatory or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.
Direct communication of Regulatory R&D Biologics strategy, planning, resources, policies and procedures to all levels and departments (internal and external). This is essential to achieve one regulatory voice and to assure consistent and effective Biologics Regulatory Development througout s-a R&D Business Divisions, TSUs, DPUs, Q&C, affiliates and in IA. The communication is achieved through involvement and collaboration throughout R&D. Extensive hands-on and leadership experience is needed to achieve this accountability and responsibility.
Direct interface with Health Authorities on Biologics Development issues to assure that collaborative long term relationships are developed to meet regulatory expectations and business needs according to defined timelines. This is essential to assure one consistent sanofi-aventis representative and voice on Biologics. Oversee, direct or participate in agency product specific meetings regarding biological products. Collaborates with senior officials at FDA and other Health Authorities, on developing guidelines and recommendations on key topics and issues. Oversee, direct or participate in industry groups that comment on and influence health authority legislation. Executive experience, education and stature are required to meet this expectation
Lead the cross functional Community of Practice for Biologics which creates establishes, mentors, trains and maintains a high level of Biologics expertise. This is required to attact, develop, mentor and retain key talent in the organization. The Community includes representatives from throughout GRA and partners such as Global Biotherapeutics and IA. Deliverables include seminars, forums and ways of working. In depth experience throughout all aspects of R&D Biologics is required to lead this activity.
Leads, directs and contributes to development of streamlined, efficient processes and procedures for GRA to facilitate accomplishment of project goals, timelines, regulatory conformance and excellence. Leads Biological CMC expertise in GRA contribution to due diligence.
Provides a vision and leadership for the regulatory policy program (PhRMA, EFPIA). Directs and participates in developing industry position papers from industry organizations. Effectively leads and participates in internal and external review and comment on evolving Health Authority regulation. This is required to establish and maintain s-a as an industry leader in shaping regulatory environment and policy. In-depth knowledge and experience in all aspects of Biologics is required for this activity.
Major Challenges/Problems:
Major challenges include the following: (1) Establishing long range regulatory strategies for multiple complex Biologics projects. Strategies require detailed/complex information, and cross functional input from Global Regulatory Affairs and Global Biotherapeutics as well as Q &C, IA and external partner companies. (2) Effective anticipation, interpretation and implementation of global regulations for Biologics when s-a viewpoints may differ internally and between s-a and the health authorities. Interpretations must be negotiated/mitigated within s-a and then with the health authorities. (3) Planning and prioritization of concurrent or conflicting submissions; normally resolved by negotiation with functions and re-establishing priorities. (4) Prudent evaluation of regulatory issues that present risk. Subsequent development of consensus-based risk-mitigation strategies (5) Recruiting, coaching, leading retaining and training biologics talent. Community of Practice across s-a functions is one tool
Key Internal/External Relationships:
Internal: This position requires significant interaction and effective working relationships with senior global management in Biologics and GRA. At appropriate intervals, all levels of Management (up to at least VP level) might be involved within Corporate Regulatory Affairs, Global Biotherapeutics, Lead Generation Dossier, Industrial Affairs, external partner companies, Quality, DPs, TSUs and DPUs.
External: Health Authority Reviewers and Executives; Professional Organizations BIO, EFPIA, PhRMA
Decision Making Authority:
All strategy decisions required to achieve the objectives of Regulatory and Global Biotherapeutics shared goals of developing and registering Biologics Products are in scope. Forward strategic thinking to anticipate and mitigate Regulatory risk are crucial to this position. Strategic, tactical, sign off and operational activities to produce dossiers will be negotiated with peers. Personnel decisions require input and negotiation with peers. High risk activities may need Senior Management (up to at least VP level) involvement.
