Job Responsibilities:

- Receive and process adverse events, preparing the report for submission to the appropriate authorities and/or agencies
- Ensure that all reporting documentation is complete
- Provide safety expertise on assigned products
- Ensure accuracy and compliance with domestic and international regulatory requirements
- Verify the accuracy and completeness of information for each adverse event report for which he/she is responsible in conjunction with the source documents

Job Qualifications:

- BA/BS degree
- Three to five (3-5) years of pharmaceutical industry experience
- Experience with data entry into drug safety databases such as ARISg/ARGUS
- Proficiency with MedDRA and other standard medical coding dictionary
- Two to three (2-3) years minimum experience in medical coding/terminology/data entry

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Recruiter: Tonya Allen

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our Recruitment Process Outsourcing services.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

Ref: 1022142

SFSF: LS

Job Responsibilities:

- Reviews these documents regularly and updates as required (e.g. when significant new information received).
- Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources.
- Ensures that this team appropriately reviews all data from various sources (e.g. pre-clinical, clinical trial data presented by Clinical Trial Head (CTH) or Medical Scientific Expert (MSE), post-marketing, literature) throughout the development process.
- Provides expert input to the clinical development program for assigned projects / brands.
- Responsible for initial development and updates of information in Basic Prescribing Information (core global labeling), including addressing issues optimally in all project / product labeling claims.
- Responsible for responses to inquiries from regulatory authorities or health care professionals on issues.
- Responsible for responses to legal queries and Country Pharma Organization (CPO) requests involving any issues.
- Provides integrated input into all regulatory documents required during active development.
- Facilitates involvement of external experts.
- Provides relevant input for GPT/GBT, Global Clinical Team (GCT) and Clinical Trial Team (CTT) meetings as needed Collaborates productively with colleagues.
- Serves as and performs activities of Pharmacovigilance Leader as needed.

Job Qualifications:

- Post graduate degree in Pharmaceutical Medicine; Master of Public Health.
- Medical Degree required.
- Specialty Board certification.
- Three (3) years of clinical experience postdoctoral.
- At least five (5) years are in drug development in a major pharmaceutical company (of which 2 years in a global position), including two (2) years in safety at an operational or medical positions.
- Experience in preparing or contributing to preparation of clinical assessments and regulatory submissions involving experience in leading cross-functional, multi-cultural teams.
- Experience with (safety or others) issue management.
- Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.

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Recruiter: Hannah Cihlar

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

J2W: HC

MONJOB

Ref: 1021683

SFSF: LS

Job Responsibilities:

- The Sr. Medical Coding Specialist is responsible for the selection and review of appropriate codes of reported terms in clinical trials not limited to adverse events, medical history and medications
- Ensure that the term is clear, appropriate and complete as per investigator's entry on the CRF otherwise, he/she is responsible for the coding query
- Abstracts all necessary information from other CRF pages for concept coding if necessary
- Assign codes using MedDRA and WHODD terminologies, which most accurately describe each panel according to established coding guidelines and conventions.
- Responsible for reviewing Safety data and write narratives for Clinical Science for data review, managing appropriate queries and finalizes narratives for inclusion in the CSR.
- Perform a comprehensive review for the all the reported and coded terms. To assure the presence of all coding targets not limited to LLT, PT and SOC and Trade name , Preferred Name ATC 2 and ATC 4 and their respective dictionary versions
- Perform Aggregate review of AEs, SAEs, AESIs and medication of clinical importance and assists in SAE reconciliation

Job Qualifications:

- Minimum PharmD or graduate of adequate health care related course with commensurate experience in use of dictionaries in Clinical trial setting.
- Minimum of five (5) years coding experience required and two (2) years of AE, SAEs Science review
- Written narratives for drug safety or clinical science review
- Strong knowledge of ICH guideline, or adequate background and have attended seminars for MEdDRA and WHODD use
- Knowledge of Central coding, Ds Navigator , INFORM a plus
- Proficiency on all related regulations, GCP, and Good Clinical DM Practice

Discover all that's possible with Yoh. Apply now.

Recruiter: Tonya Allen

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: HC; J2W: CLINICAL

MONJOB

Ref: 1022888

SFSF: LS

Job Overview:

The Sr. Clinical Trials Specialist (CTS) will, under the direction of the Manager, Medical Operations, provide support in the in the daily activities of managing and coordinating the operational efforts in the development and implementation of research-driven, Investigator Initiated Trials with close collaboration with the Regional Medical Liaison and research sites. The individual will be responsible for hand-on management and tracking of all aspects of the Investigator Initiated Trials. This includes but not limited to the review of study protocols, consent forms, regulatory documents, submission of IND safety reports, study input and tracking in global approved clinical trial database, processing clinical drug requests and investigator payments. The CTS will be responsible for all study activation activities through completion of publication all while ensuring regulatory integrity and SOP compliance. The CTS will be responsible for maintaining constant knowledge of there assigned studies and provide management with study information as requests. CTS will also file and audit studies in the Trial Master File at the completion of the study or as required throughout the study.

Job Responsibilities':

- Essential functions include but are not limited to the following:
- Assists in the management of all aspects of Investigator Initiated Trials
- Adjusts priorities and demonstrates adaptability, identifies and implements new or different ways to achieve goals.
- Knowledge of the drug development process in the planning and management of clinical studies.
- Develops and delivers information in a clear and concise manner within company and clinical research guidelines.
- Listens actively and shares relevant information with others.
- Develops effective working relationships with business partners to achieve business goals.
- Identifies, analyzes, and communicates problems, issues, and opportunities. Develops and implements effective solutions to achieve desired outcomes.
- Demonstrates an understanding of study drug and industry competition.
- Understands the disease state and treatment options.
- Develops project plans and manages multiple projects to achieve goals within established timelines.
- Ability to create and deliver a presentation
- Evaluates and manages time and resources.
- Collaborates to identify strengths and developmental areas; creates, owns, and implements professional development plan.
- Assist with any special projects as assigned.

Job Qualifications:

- BS/BA in a health-related science or RN.
- One to six to eight (6-8) years of experience in clinical research, clinical coordinator, clinical nurse role or an equivalent combination of education and experience.
- Knowledge of drug development process, FDA, ICH, and GCP guidelines.
- Ability to communicate effectively in the English language in person, by phone and writing.
- Excellent organizational skills.
- Ability to work collaboratively, effectively, and productively in diverse organization structures.
- Ability to work in a team-oriented, collaborative environment.
- Ability to demonstrate leadership capabilities.
- Solid computer skills and practical knowledge of MS Word, Excel, PowerPoint and project management software.
- Ability to create and deliver presentations to management or team members.
- Must be flexible and manage change easily.
- Ability to work positively within a continually changing environment.
- Ability to problem-solve
- Ability to effectively prioritize and execute tasks in a high-pressure environment.

Preferred Job Skills / Experience / Knowledge:

- Oncology experience is strongly preferred.
- Investigator Initiated experience preferred.

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

Ref: 1022769

SFSF: LS

Job Responsibilities:

- Perform significant SAS programming for protocols on a regular basis
- Responsible for developing SAS macros
- Write specifications and be responsible for documentation

Job Qualifications:

- MS degree strongly preferred, in statistics/biostatistics
- five (5) plus years experience supporting clinical trials in the Pharmaceutical industry
- Strong drug development background and experience programming all phases of clinical trials, with NDA/submission experience
- Experience leading statistical programming activities for drug projects and interacting with clinical project team members and statistician
- Strong technical SAS programming skills required, including comfort with all aspects of using and developing SAS macros
- General familiarity with CDISC SDTM and ADaM
- Ability to work independently
- Project management experience

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

Tax Term: CON_W2

J2W: CLINICAL; J2W: INFOTECH

MONJOB

Ref: 1022105

SFSF: LS

Job Responsibilities:

- Provide and/or implement global CMC regulatory strategy for development projects or marketed products
- Lead or contribute to global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions
- Make quality regulatory decisions, balancing risks and benefits
- Identify required documentation and any content, quality and/or timeliness issues with them and negotiate the delivery of approved technical source documents in accordance with project timelines
- Contribute to Health Authority interactions and negotiations as appropriate
- Set objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans
- Lead or contribute to cross-functional CMC Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, and prepare CMC responses, as appropriate

Job Qualifications:

- Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent OR Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- At least four (4) years in regulatory project management preferred, and/or experience in drug/biopharmaceuticals
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
- Knowledge of the drug development process desirable
- Ability to critically evaluate data from a broad range of scientific disciplines

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Recruiter: Helana Nosratbakhsh

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading workforce solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOB

Ref: 1022948

SFSF: LS

Job Responsibilities:

- Responsible for regulatory compliance of pesticides in the US (state and federal agencies) and Canada.
- Will be working on commercial pesticide feeds, AAFCO, NASC, and FTC.
- Responsible for regulatory compliance of feeds under the state agency authority (AAFCO) including representation on industry trade associations.
- Manage the submissions to EPA and PMRA (Notifications, Minor Formulation Amendments, New Product and Active Ingredient Registrations).
- Responsible for nationwide registrations and renewal of pesticide products.
- Monitor Pesticide database for competitive assessments.
- Manage the database for Adverse Effects Reporting, preparation of submissions in accordance with federal, state and international requirements.
- Investigate and resolve compliance issues, questions, or complaints received from internal departments, external customers and government agencies.
- Manage the database on feed analysis reports; state registered products and product labels.
- Assist in the development, review and approval of advertising and product label copy.
- Monitor legislative changes, new guidance documents, and review activities related to products and communicate internally.
- Manage the Hazard Communication process including the implementation of Material Safety Data Sheets.

Job Qualifications:

- B.S. in Chemistry, Biology, or an applied science.
- Seven to ten (7 - 10) years of regulatory affairs work experience in the consumer products Industry.
- Work experience in regulatory affairs in the pet food and/or pesticide consumer products industry is considered a plus. EPA experience is also considered a plus.
- Highly motivated individual that requires minimal supervision.

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Recruiter:?Lindsay Lee Morgan

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our Recruitment Process Outsourcing services.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

Ref: 1021645

SFSF: LS

Job Responsibilities:

- Perform microbiological testing on water, pharmaceuticals, medical devices, cosmetics, personal care products, chemicals, food, and food constituents.
- Help complete sample work instructions for corresponding sample testing.
- Lift and carry lab equipment and materials such as Petri dish boxes, boxes of water, lab softgoods and samples.
- Participate in quality control activities and functions throughout the lab including, but not limited to, media and diluents negative controls.
- Conduct performance checks on balances.
- Participate in preventive maintenance program for lab equipment.
- Participate in cleaning lab work areas, workstations and equipment.
- Participate in disposal of lab trash.
- Empty, clean and re-fill water baths.
- Clean lab carts.
- Perform Spor Klenz RTU spraying of lab areas at end of work day.
- Participate in re-stocking lab supplies.
- Comply with safety rules and regulations.
- Comply with personal hygiene and hand washing policies.
- Report low inventory of supplies to supervisor.
- Report damaged equipment or materials to supervisor.
- Read and follow SOPs.
- Help other lab technicians as needed.
- Assist with lab assistants' tasks as needed.

Job Qualifications:

- Degree: BS or BA or equivalent
- Good oral, written and technical communication skills.
- Math aptitude
- Organizational skills.
- Planning skills.
- Professionalism
- Reading skills.
- Time management skills.
- Ability to stand for extended periods of time
- Ability to climb ladders

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Recruiter: Sidra Javed

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC

Ref: 1023473

SFSF: LS

Job Overview:

Our Client is seeking an experienced scientist to join the Translational Development team. The successful candidate will have proven knowledge of autophagy in the context of normal and tumor cell growth with excellent technical skills in biochemistry, cell and molecular biology. Expertise in oncogenic signaling pathways as well as 3-D culture growth assays is a plus. Being well versed in the scientific literature, the employee will use current techniques to address questions of drug mechanism of action, differentiation and resistance using primarily in-vitro methods. In-vivo studies will be coordinated through a separate research facility, contract research laboratories, and academic collaborations. Will be responsible for well-defined and controlled experiments being mindful of translational relevance; responsible for experimental design, interpretation of results and making scientific presentations to senior management. Employee will keep an electronic laboratory notebook and write non-clinical pharmacology study reports. The qualified individual will have completed a Ph.D. program together with a productive post-doctoral position.

Job Responsibilities:

- Develop in-vitro assays for evaluating mechanisms of drug resistance, drug differentiation and biomarker marker identification.
- Perform mechanistic studies using gain- and loss-of-function approaches such as gene silencing and recombinant protein expression.
- Study the intracellular signal transduction cascades and feedback mechanisms within pertinent cell types to assess mechanism of action and rationalize drug combination strategy.
- Interface with bioinformaticians to analyze genomics data for understanding pathways of resistance and differentiation of CLIENT'S drugs in development.
- Participate in translational team meetings to present data and provide interpretation.
- Supervise Associate Scientist(s) and/or Research Associate(s) as needed, and under the direct but limited supervision of management.
- Analyze, interpret, and report experimental results.
- Establish and maintain working relationship with contract laboratories and relevant academicians
- Ensures that the Translational Development Department maintains current awareness in area of expertise, enhances the scientific credibility of CLIENT through contributions to the scientific literature (publications / presentations), through extramural activities and scientifically related interactions with academics.
- Assumes responsibility for writing non-clinical pharmacology study reports, invention disclosures, and contributes to the writing of investigator brochures, IND applications, regulatory annual reports, and other regulatory documents when appropriate.

Job Qualifications:

- Ph.D. degree (or equivalent) in biochemistry, molecular or cellular biology with at least three (3) years of productive research experience at the postdoctoral level, as evidenced by an appropriate publication record.
- Relevant skills include designing and performing cell-based assays and proficiency in molecular biology (molecular cloning, transient and stable gene silencing, recombinant protein engineering) and cell biology (transient and stable engineering of cell lines, immunocytochemistry, microscopy) techniques.
- Documented experience in the autophagy-lysosome pathway is essential and expertise in tumor cell signaling as well as 3-D culture systems is a plus.
- The qualified candidate will be self-motivated and possess strong interpersonal and communication skills with a demonstrated ability for creative thinking and problem solving.
- Excellent communication and interpersonal skills demonstrated in a team environment are essential to effectively convey scientific concepts and data to internal working groups / project teams and external academic and industrial organizations.

Discover all that's possible with Yoh. Apply now.

Recruiter: Sidra Javed

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our Recruitment Process Outsourcing services.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

Ref: 1022333

SFSF: LS

Job Overview:

- The candidate will work independently and contribute to a joint research team effort focused on our CLIENT'S drug discovery and development in the field of oncology.

Job Qualifications:

- Candidates must have a BS or MS degree in a bioscience
- Two (2) plus years of industry experience.
- Strong experimental skills in molecular and cellular biology, mammalian cell culture, assay development and compound screening in biological assays are required.
- Have excellent interpersonal, organizational, supervisory and problem-solving skills.
- Expertise in cell culture, cell transfection, stable cell line generation and protein detection assays (western blot, ELISA, immunofluorescence assays, etc.), is required.
- Experience in tissue culture, molecular cloning and assay development.
- Experience with KRAS
- Strong communication is a must in this group.

Preferred Job Skills / Experience / Knowledge:

- Strong oral and written communication skills, including strong presentation skills, are a plus
- An MS degree is preferred

Discover all that's possible with Yoh. Apply now.

Recruiter: Sidra Javed

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

Ref: 1022775

SFSF: LS

Job Responsibilities:

- The Clinical Project Manager leads the project team and ensures the successful conduct of domestic and international clinical projects through effective direction of the Project Team, compliant with Good Clinical Practices (GCPs), SOPs and study protocols.?
- Manages all aspect of designated projects - responsible for on-time, successful, on-budget delivery of assigned projects.
- Establishes objectives and strategies to direct activities, evaluate capabilities, and track, measure, and report the status of project milestones.
- Defines and manages project resources including contingency plans for key resources.
- Ensures appropriate communication and accurate reporting of critical project-related matters and information to senior management and client.
- Develops, implements, manages and revises project plans to ensure successful project delivery.
- Develops and implements enhancements to improve project quality and efficiency.??
- Functions as primary contact for project issues, including the planning of deliverables and the managing of budgets.
- Identifies critical project tasks/issues and recommends course(s) of action to expedite project objectives.
- Conducts regular Project Team Meetings including distributing action items with assignments and due dates.?
- Supports Business Development activities including identifying potential projects with current or new clients, participates in business proposal generation and capabilities presentations.??

Job Qualifications:

- B.S. degree in nursing, pharmacy, or related health field, or experienced in healthcare; advanced is degree preferred.
- Five plus years related experience from the pharmaceutical industry or a CRO along with management expertise including a history of supervising direct reports and successful management of oncology studies.
- Oncology trial management experience within the past 12 months required.?
- Thorough knowledge of the pharmaceutical clinical drug development process and team-based matrix management.?
- Knowledge of Good Clinical Practices (GCPs)
- Current knowledge of Pharmaceutical R&D and therapeutic area developments.
- Ability to travel both domestically and internationally as required.

Discover all that's possible with Yoh. Apply now.

Recruiter: Lindsay Lee Morgan

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

Ref: 1014939

SFSF: LS

Job Responsibilities:

- Assist the senior members of the IVRS department with user acceptance testing (UAT) and quality assessments of new IVRS and IWRS projects to ensure correctness of system performance and CLIENT'S requirements are being met.
- To assist with the UAT set-up activities.
- Organize and conduct validation of IVRS and IWRS against requirements approved by CLIENT.
- To maintain appropriate documentation and ad hear to documentation practices (validation documentation in accordance with IMSC IVRS departmental SOPs).
- Coordinate with Vendor UAT set-up and execution of User Acceptance Test scripts.
- Undertake quality and audit procedures in accordance with IVRS departmental SOPs.
- Collaborate with IMSC IVR business analysts and study teams to verify requirements and ensure UAT approach is agreed upon.
- To ensure that all UAT documentation, including validation scripts, checklists, worksheets, UAT outcomes and certificates are available for future review and are stored in accordance with the relevant SOP and CLIENT'S requirements.

Job Qualifications:

- BA / BS Life Sciences / Computer Science or related technical area / Management Information Systems PLUS.
- One (1 +) years clinical technologies experience with direct experience with IVRS validation OR Equivalent.
- Preferred experience with IVRS (validation and design) and clinical supplies chain management.
- Demonstrated skills in management of multiple projects simultaneously.
- Familiarity with legislative and regulatory requirements with respect to investigational drugs.
- Knowledge and ability to apply FDA 21 CFR Part 11 requirements.
- Analytical and problem solving skills.

Discover all that's possible with Yoh. Apply now.

Recruiter: Sidra Javed

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our Recruitment Process Outsourcing services.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: INFOTECH; J2W: SCIENTIFIC

Tax Term: CON_W2

Ref: 1022473

SFSF: LS

Job Responsibilities:

- Contribute to the design of and oversee the implementation and conduct of phase II-IV trials and local phase IV trials in the US (Cardiovascular or Women's Health.)
- Responsible for the safe conduct of clinical trials to GCP, ICH and in line with FDA regulations. Responsible for oversight of adverse event reporting from clinical trials
- Develop publication / communication plans for local phase IV studies
- Provide Medical input to Medical/Marketing strategy and operations via the US Brand Team
- Responsible for oversight of analysis and publication of local phase IV studies
- Review of promotional materials
- Provides knowledge of GCP and local regulations

Job Qualifications:

- MD or PharmD or PhD
- Minimum of three to five (3-5) years of research / Medical Affairs experience in a pharmaceutical setting
- Medical and scientific writing skills.
- Familiar with all aspects of drug development and GCP
- Knowledge of clinical trial design statistics and pharmacokinetics
- Ability to analyze and interpret results. Understanding of marketing principles and strategies
- Fluent in English and excellent verbal and written communications skills are required
- Good management, planning/organization, team working, strong interpersonal skills and Networking

Discover all that's possible with Yoh. Apply now.

Recruiter: Helana Nosratbakhsh

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading workforce solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOB

Ref: 1023023

SFSF: LS

Job Responsibilities:

- Development, qualification, and implementation of biological characterization methods for protein therapeutics.


- Design and implementation of experiments to investigate protein product quality attributes.
- Prepare all lab document / protocols.
- Focus on established and new art science and technology to meet project.
needs for analytical sciences.
- Work closely and support Bioassay, QC and Process Development on scientific issues.
- Support publication and patenting of scientific work.


- Analytical Characterization of protein therapeutics.


- Design and execution of experiments to delve into product-related substances and impurities and their biological relevance
- Characterization of product and process-related impurities in Process Development / i-process samples.
- Design and execution of multi-arm stability studies to assess biologics degradation pathways
- Execution of comparability studies


- Culture


- Support business development activities as required.
- Support solutions for innovation and collaboration.
- Develop customer relationships with peers.

Job Qualifications:

- BS / MS in Biochemistry / Biotechnology, Cell Biology, Immunology or related field.
- Minimum of three (3) years of pharmaceutical / biotech industrial experience in functional biochemical / cell-based assay, potency assay.
- Strong working knowledge of GMP regulations. Experience with the use of ELNs in a compliant environment is a plus.
- Proven track record supporting biologics drug development.
- Solid experience with functional and potency assay development, validation, and tech transfer.
- Strong scientific understanding and experience with ELISA, flow cytometry, Biacore / surface plasmon resonance, cell signal transduction, reporter constructs, molecular biology, FACS, and mammalian cell culture. Experience with comparability studies and regulatory filings preferred.
- Motivation to be part of a high performance, efficient scientific team.
- Excellent spoken and written communication skills.

Discover all that's possible with Yoh. Apply now.

Recruiter: Sidra Javed

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading workforce solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL; J2W: SCIENTIFIC

Ref: 1015076

SFSF: LS

Job Responsibilities:

- Commercialize global products in local markets.
- Partner and work closely with Global R&D.
- Lead and support technical assignments in areas of new product / process development and product / process improvement.
- Participate as an active member of cross-functional business teams including marketing, operations, quality, purchasing, regulatory and legal.
- Provide technical leadership and project management to deliver business objectives
- Lead commercialization project team.
- Define, initiate and execute projects to identify and implement projects to improve product quality, to reduce raw material and formula costs, and to successfully launch purchase-complete products.
- Technically drive refinements in formula and process development of novel food ingredients and formulas to meet consumer and customer needs by leveraging the latest ingredient, flavor and nutrient technologies, studying trends, and competitor products.
- Develop proprietary ingredients, formulas and products that can be patented and will provide CLIENT's sustainable competitive advantage.
- Responsibility to protect confidentiality.
- Recommend food manufacturing and blending processes, systems, and technologies;
- Lead scale-up and commercialization.
- Develop ingredient, formula and process specifications to ensure product quality, safety and consistency at lowest cost.
- Develop and coordinate experimental designs and testing to evaluate efficacy, palatability, safety and shelf life of new products; analyze data, prepare reports and recommend action plans.
- Coordinate sensory, microbiological or chemical analyses, product shelf-like tests, and off-site research and testing.
- Manage and mentor junior scientist/s.
- Provide documentation to manufacturing leadership that is critical for the day-to-day operation and continued maintenance of a processing system.
- Provides an understanding of the impact of the key processing parameters in the conversion of raw ingredient and in-process material to finished product.
- Able to utilize and manage external resources to deliver project objectives.

Job Qualifications:

- Candidate must have a Bachelor's degree, (Masters preferred) plus eight to ten (8 - 10) years of experience in food product development.
- Expert in developing executable processes suitable for implementation in a manufacturing facility within the project timeline and budget.
- Able to define the physical and chemical transformations that must occur to produce food products along with their individual processing parameters.
- Capable of making critical decisions under pressure with limited information.
- Able to champion and implement new ideas and technologies.
- Working knowledge of Pumps, Heat Exchangers, Extruders, Depositors and Mixers.
- A good understanding of mechanical equipment design and fabrication, including materials of construction and design specifications for the food industry.
- Responsible for process optimization during start up and early production.

Discover all that's possible with Yoh. Apply now.

Recruiter: Sidra Javed

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC

Ref: 1022141

SFSF: LS

Job Responsibilities:

- Support Regulatory Affairs personnel in the coordination, preparation, and submission of all INDS/NDAs/MAAs and life cycle management of these submissions in both paper and electronic format."
- Responsible for the creation and compilation of quality Regulatory submissions and lifecycle management submissions. Planning, preparing, tracking, and archiving regulatory documents and submissions.
- Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including MAAs/NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
- Responsible for maintenance of all Regulatory and FDA correspondence (distributing, and archiving into electronic document management system) within specified time frames.
- Verification of regulated documents via workflows within Celgene's electronic document management system (eSub livelink).
- Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
- Liaise with functional source areas (clinical, nonclinical, cmc, regulatory) to ensure documents are compliant with authoring style guide. "Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications"
- Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
- Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
- Close interaction with authoring community to track availability of deliverables.
- Other responsibilities related to the above within Celgene as a whole, as assigned.

Job Qualifications:

- BA/BS Degree, two (2) years pharmaceutical industry experience, prior Regulatory Operations experience required
- Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic
- Knowledge of industry trends regarding electronic submissions
- Technical knowledge of electronic publishing systems and software
- Proficiency with MS-Office Suite and Adobe Acrobat applications
- Knowledge of health authority procedures/guidance's regarding electronic submissions
- Knowledge of Electronic Document Management Systems
- Ability to balance multiple tasks to meet priorities and timelines
- Self-starter with superior time management skills, and ability to work independently or in teams
- Strong attention to detail

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our Recruitment Process Outsourcing services.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

Ref: 1022578

SFSF: LS

Job Responsibilities :

Job Qualifications: