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Technical Recruiter (Contract)

Irvine, Ca

Develop and establish recruiting strategies and processes aligned with business objectives and company goals.
Collaborates with hiring managers to clarify staffing requirements, source and prescreen candidates, schedule interviews, assess candidate for proper cultural fit, candidate correspondence, prepare employment offers and candidate closeout, manage applicant flow, and other administrative tasks related to recruitment.
Manage a pipeline of candidates and keep relationships warm.
Manage the internal and external job postings using the Internal Careers site, social networking sites, professional associations, etc. to drive the company brand and build and develop a robust talent pipeline to meet the strategic needs of the business.
Anticipates talent planning needs based on strategic direction of the company.
Screens applicant resumes and initiates contact with qualified candidates for specific assigned job openings.
Uses traditional and non-traditional sourcing techniques to include researching and identifying markets to tap for qualified talent.
Maintain accurate and well-ordered documentation on all candidates, searches, hiring managers’ interactions, and other recruiting activities and accurate utilization of applicant tracking system according to standards.
Maintain the applicant tracking system, create and post requisitions, facilitate resume reviews, assessment of candidates, debrief sessions, and candidate tracking.
Proactively generate a continual, diverse pipeline of highly-qualified candidates.
Develop and establish recruiting strategies and processes aligned with business objectives and company goals.
Build and maintain proactive partnerships with all internal client groups in order to better understand their business, managing their staffing needs and issues, and offer ideas, solutions and tools.
Drive recruiting strategies that continually replenish candidate pipelines based on market conditions and current and projected engagements/needs.
Execute creative recruitment and sourcing activities including, but not limited to: direct sourcing, industry networking, Internet-based and social media recruiting, vendor management, diversity, and outreach to appropriate trade and industry organizations.
Creatively develop, execute, and/or assist with a variety of staffing projects and initiatives.
Manage new hire offer process and ensure compensation packages are competitive with market and industry standards.
Provides appropriate counsel and recommendations throughout the entire acquisition process on candidate assessment and selection, offer recommendation, and other guidance as necessary.
Negotiate job offers and effectively overcome objections
Familiarity with behavioral interviewing.
Ability to lead hiring teams to a consensus during integration meetings.
Responsible for ensuring accurate administration of candidate and requisition status reports, hiring metrics, compliance with EEOC regulations and company recruitment policies.
May perform other duties as assigned by Supervisor and/or Lead Talent Acquisition Partner.
Required Experience:
Bachelor’s degree in Business Administration, Human Resources, Communications, or a related discipline required.
Must have 2-5 years of high volume in-house technical and non-technical recruitment experience.
Must have significant knowledge of best hiring practices, behavioral-based interview techniques, compensation, applicant tracking processes, and recruitment metrics.
Demonstrated success in implementing innovative methods to source and attract passive candidates.
Knowledge of common human resources practices, employment and immigration laws and/or government compliance regulations as it relates to recruitment and hiring.
Solid and persuasive verbal, written, and consulting communication skills; ability to market the company value proposition and opportunities with candidates and influence them to join the organization.
Exceptional interpersonal, social and communications skills with strong business acumen and demonstrated ability to quickly establish rapport, build credibility and create partnerships at all levels within the company.
Able to multi-task and meet deadlines with a sense of urgency, while working in a high volume, fast-paced environment.
Ability to handle ambiguity, stressful and/or confidential situations with ease, professionalism, and savvyness.
Knowledge of compensation best practices.
High energy, enthusiasm, passion for recruitment, and sense of urgency levels.
Ability to think through multiple alternatives and potential consequences to determine the best outcome.
Familiarity with automated applicant tracking tools, HRIS systems (Taleo, Bullhorn, UltiPro, etc.), MS Word, Excel and Outlook.


Instructional Designer

This position will play a critical role in our Training and Development Department. The successful candidate will be responsible for branding, development and re-design of training materials. Key responsibilities will include the following:

•Design and develop training curriculum and tools, job aids and leader guides
•Redesign and brand existing materials as needed
•Partner with appropriate stakeholders and subject matter experts to conduct needs and job task analysis, and develop training
•Support the implementation of curriculum and evaluation of training effectiveness
•Create new hire training materials as well as professional and leadership development curriculum
•Consistently apply adult learning theory and instructional design principles to the development of materials
•Provide instruction to training facilitators
•Coordinate with outside vendors and consultants when needed
•Demonstrate graphic design and illustration skill

•College degree or equivalent education and job experience in Instructional Design, English or Communications
•Minimum 3-5 years work experience in Instructional Design
•Ability to demonstrate a consistently high quality of workmanship in training documents
•Strong organization, communication and project management skills required
•Excellent verbal and written communication skills
•Graphic art skills and CBT/ Web design skills preferred.

Scientist–Analytical Protein Development

We are seeking an independent, organized and energetic Scientist to be a key member of a dynamic fast-paced research and development organization. He/she should be an enthusiastic, creative thinker who will contribute to continuous improvement of existing methods and will be spearheading introduction of new physicochemical methods for protein characterization. Job candidate must be a goal-oriented team player with excellent communication skills and adapted to a time-line driven work environment. Finally, he/she must be able to work in a team structure and interface with different research and development departments (including collaborators and contract labs).
Job Requirements:
• Ph.D. in biophysics, biochemistry or related field with 4+ yrs industrial experience in protein analytical development
Understand and have hands-on experience with a wide range of analytical chemistry techniques (including but not limited to): HPLC, HPLC-MS, UV, gel electrophoresis, protein mapping, and calorimetry
•Take ownership of analytical method development for complex protein biomolecules (including E. coli, yeast, CHO derived proteins/antibodies and PEG -protein conjugates) and related impurities conducting the preliminary qualification of these test methods for protein therapeutic candidates in pre-clinical and early-phase clinical development.
•Characterize proteins and impurities utilizing conventional and specialty analytical techniques to understand degradation pathways and improve protein stability
•Design and perform formulation development activities including forced degradations and real-time stability studies
• Write standard test methods, qualification protocols and reports.
•Work with the process development group at Ambrx to provide analytical support to assess the purity, potency and stability of protein therapeutics
•Be able to communicate effectively with various functional areas in the company and with outside collaborators
•Summarize, interpret, and critically evaluate analytical data. Present results at Group/Team meetings.
•Knowledge of statistics and the ability to interpret experimental data to summarize the key findings. The position requires good problem solving skills using multiple analytical techniques.
•Excellent oral, written and interpersonal communication skills and an ability to work across scientific disciplines.

Research Scientist-In vivo pharmacology

We are seeking a talented Research Scientist to join our clients’ in-vivo pharmacology group.
The Research Scientist will work as part of the Pharmacology team assisting in the development, validation and implementation of in vivo tumor models for profiling the pharmacological effects of drug candidates.
The successful candidate will have a Ph.D. degree and minimum four plus (4+) years experience in small molecule drug development and oncology research. Experience with in-vivo oncology models is required as is experience with pharmacodynamic marker analysis. A sound understanding of kinase signaling pathways and mechanisms in oncology is required. Industry experience is preferred. Competence with Excel, Word, Power Point, and graphic applications, as well as excellent writing, communication, and interpersonal skills are very important. Management experience is a plus.

QA Specialist

Our client, an innovative developer and manufacturer of diagnostic instrumentation and test kits located in Sorrento Valley is looking for a Quality Assurance Specialist. The chosen candidate will be responsible for performing a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements.
Essential Duties and Responsibilities
•Maintenance of CAPA, NCMR and complaint systems; internal and external audits; monitoring and implementation of training programs, data and documentation review.
Essential Requirements
•Bachelor’s degree in a scientific field and minimum of 2 to 4 years of experience in the medical device or pharmaceutical industry.
•Knowledge and skills through relevant industry experience in quality assurance systems. Working knowledge of the Quality system Regulation (21 CFR Part 820).
•Strong documentation and verbal communication skills.
•Ability to work independently and as a team member with strong organizational and self-management skills.
•Able to read, understand, and adhere to Standard Operating Procedures, cGMP’s (current Good Manufacturing Practices), ISO 9000, and other government regulations written in English.
•Able to maintain a high and consistent service level and operate under deadlines. Able to maintain accuracy and provide attention to details, multi-task, and demonstrate excellent organizational skills.
Desired Skills
•Bachelor degree in a life science.

Senior Automation Project Engineer

Specific Responsibilities :
• Provide engineering design and project management support to wide variety of site tasks and Automation projects.
• Provide technical support to operation and coordinate efforts from different disciplines on the engineering Automation projects
• Provide planning and manage multi complex projects on schedule and coordinate parallel activities.
• Coordinate with Facilities Maintenance, EHS, QA, Operations and Validation groups.
• Manage external factors such as planning and inspections.
• Develop capital budgets, obtain approvals for and adhere to project scope. Negotiate with contractors and suppliers to keep the projects within budget.
• Assure that value engineering, constructability reviews and similar processes are effectively utilized to minimize capital expenditures and maximize functional values.
• Demonstrate leadership, team-skills, self-confidence and effective decision making throughout a project.
• Assure compliance with good engineering practices, cGMP, GLP, company policies, regulations and codes.
• Expert understanding of project management from inception through completion of IQ/OQ including scope, design, cost and scheduling
• The candidate should have experience in setting the criteria for cGMP automation systems for the pharmaceutical or biotechnology industries.
• Experience in directing contractors in programming methodology and testing criteria.

Technical skills
• Extensive experience with PLCs, process controls, and Control logix,
• Experience with packaging line automation integration, and vision systems.
• Networking experience with ControlNet, EtherNet,DH+ and DH485
• Extensive experience with HMI/SCADA system such as GE Fanuc Proficy/ Intellution iFIX, WonderWare and OSI PI.
• Experience in Visual Basic, VBA, CC+
• Extensive knowledge of 21CFR11. Familiarity with establishing systems and procedures to ensure compliance with applicable regulations
Essential Duties and Job Functions :
• Establishes operating specifications and improves manufacturing techniques.
• Independently resolve a wide variety of issues of complex scope.
• Participates and may lead cross-functional project teams.
• Coordinates contract personnel through completion of assignments.
• Responsible for project design, project management and financial management of facility and equipment projects.
• Implements and integrates equipment and systems with minimum interruption to operations.
• Designs mechanical systems and water process systems.
• Provide automation and engineering input into the design and development of manufacturing processes for drug products, taking into consideration problems inherent in the transfer of technology from research to manufacturing.
• Performs installation/operational qualification portions of pharmaceutical projects.
• Independently resolve a wide variety of issues of complex scope.
• Independently manages assigned projects through completion.
• Coordinates contract personnel through completion of assignments.
• Contributes to the development of new concepts, techniques, and standards.
• Ensures solutions are consistent with organization objectives.
Knowledge, Experience and Skills :
• Typically requires a BS / MS in engineering discipline with a minimum of 5 years experience in the pharmaceutical industry.
• Must be able develop solutions to a wide range of moderately complex problems which require the regular use of ingenuity and innovation.
• Excellent verbal and written communication skills and interpersonal skills are required.

Director, Research & Development

This individual is responsible for developing medical strategies for the combination of diagnostics and therapeutics to detect or identify best therapeutic and disease management strategies on an individualized patient basis.

Responsible for diverse problem solving in the areas of human diagnostics for the control and treatment of oncology, immunology, infectious diseases, endocrinology and autoimmune disorders
Interacts with world class pharmaceutical companies to develop diagnostics strategies for disease management
Detects/identifies best therapeutic/diagnostic strategies on an individualized patient basis
Communicates effectively with clinicians to address current and future clinical best practice concerns with possible therapeutic and diagnostic solutions
Communicates with management in developing long range strategies for best diagnostic approaches to improve personalized medicine specialty therapeutic opportunities
Assists with acquiring and marketing branded pharmaceutical products in focused specialty markets using diagnostic strategies and serves as a spokesperson when discussing scientific options
Leads the development and launch of late-stage pharmaceuticals and complementary diagnostics
Responsible for forecasting headcount to meet project needs
Assists with the sales process by providing unique diagnostic products
Responsible for project budgeting and capital equipment budgeting
Writes or advices on the development of patents and intellectual property.
Other duties as assigned.

Generally requires a PhD degree with a minimum of 15 years of experience in developing diagnostics; diverse therapeutic area experience is preferred. At least 8 years of managerial/leadership experience required. Strong understanding of and expertise in combining diagnostic assays to identify and stratify specific diseases and therapeutic selection is preferred. Publications in peer reviewed journals on improved methods for diagnosis of primary disease states and predicting drug efficacy on an individualized patient basis strongly preferred. The individual should be considered as a leader in the field of personalized medicine using the best combination of diagnostic and therapeutic approaches. Strong leadership and collaboration skills with the proven ability to build productive relationships and teams, internally and externally, and to ensure strategy alignment from the top through the organization required. Experience working in GLP/GMP/FDA/CLIA regulated atmosphere required. Internationally recognized within the field through publications, meetings and/or work strongly preferred.

Quality Engineer – Medical Device Company

Education/Experience: Bachelor’s degree (B. A.) from four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience.

Position requirements and responsibilities include:
• Develop quality assurance specifications, test methods, sampling plans and related written procedures.
• Qualify and implement document changes involving product or process changes.
• Coordinate the root cause analysis reporting of Non-Conforming Products, Customer Complaints and Return Good Authorizations.
• Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, and Research and Development functions.
• Complete projects in a manner of consistent with corporate objectives.
• Participate in Material Review Board Meeting.
• Work with the Manufacturing, Sales and Marketing, Research and Development functions to coordinate pilot production of new process validations and risk analysis (FMEA).
• Support new product/line extension projects involving risk analysis, Master validation plan, product V & V, Process Validations and transfer design to manufacturing.
• Develop, implement and provide technical support of Quality Plans.