R&D

R&D

Research and development is a serious investment in time and money โ€“ on average, large multinational drug companies spend 17%of their revenues of R&D, while it takes ten years on average to bring a new drug to market. The latest release of DrugBank contains over 13,000 approved drug entries that are available in the global market. According to a report from the World Health Organization there are more than 10,000 types and 1.5 million pieces of medical devices or equipment available today.

Myles Whiting, design team leader at medical device company Owen Mumford, echoes the importance of this collaborative effort in research and development, โ€œProduct designers must work with marketing teams to establish unmet market and customer needs, then marketing teams interpret and deliver market context and customer needs to the engineers, who then have the ability to process this into measurable design input. The research and information is gathered, this is then accumulated into a brief which the designer uses to address the market or customer need.โ€

The Federal Institute for Drugs and Medical Devices (Bundesinstitut fรผr Arzneimittel und Medizinprodukte) (BfArM) is the body that regulates drugs and medical devices in Germany. Technological advancements are proving key in their advancement into the research of medical devices. The emergence of โ€˜big dataโ€™ has โ€œincreased quantities of data on offer to the BfArM, giving them the opportunity to quickly gain more insights on medical device risks in the future.โ€ The number of medical device incident reports received by the BfArMper year has approximately tripled in the past ten years. In 2017, almost 14,000 reports were received, and this number continues to grow thanks to the amount of the amount of โ€˜big dataโ€™ information gathered.

Technological advancements have reduced the cost of research and development โ€“ helping to accelerate investment in life sciences โ€“ while also creating new opportunities for product innovations as the Fourth Industrial revolution blurs the boundaries between the biological, physical and digital worlds. According to a report by KPMG, the cost of drug R&D will drop by 2030, leading to numerous benefits for both the industry and consumer in terms of cost savings.

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We have over a decadeโ€™s worth of experience as a leading talent partner in Life Sciences & Pharma.

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A vast, global network of the best, in-demand professionals, working with the worldโ€™s largest Life Sciences institutions, to take drugs, devices and therapeutic applications through from conception to completion.

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Our award-winning talent specialists offer bespoke, tailored guidance on the latest hiring trends and industry news to help you achieve your goals.

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R&D Jobs

Sr. Scientist, Upstream Process Development

SUMMARY This clinical-stage biopharmaceutical company is looking for an innovative scientist with a strong background in Upstream Process Development to oversee the development of all upstream technical activities for their lead vaccine program. They will also be expected to oversee CRO/CDMOs to make sure all areas of the drug substance process development and manufacture are in compliance with QbD and cGMP requirements, the chosen candidate will work hands-on in the lab with hybrid flexibility. RESPONSIBILITIES: Will design, develop, and implement fermentation & cell culture techniques, protocols, and technologies Assist internal and external partners with the scaling up, tech transfer, optimization, and validation of upstream cell culture and viral vector unit operations in support of clinical manufacturing. Oversee CDMOs for deliverables and timelines related to upstream tech transfer. SME for all upstream drug substance actions that support clinical development and IND filing. Collaborate with the technical team and CDMO partners on process design, optimization, and characterization. Provide technical oversight, guidance, and troubleshooting to help CDMO partners successfully create a reliable and efficient process. Ensure that clinical materials are delivered on schedule and that there are smooth transitions from process development to successful regulatory submissions. Write and evaluate CMC sections & technical reports needed for regulatory submissions. QUALIFICATIONS: Master's or PhD in Chemical Engineering, Microbiology, Biochemistry, or related degree with 4-5 years of industry experience (PhD) or (MS +8 years) developing upstream processes. Prior hands-on experience with viral vaccines, insect/mammalian, & recombinant proteins is highly desired. Track record of successfully organizing and managing deliverables internally and external (CMO Management is a PLUS). Solid understanding of the ICH Q8 criteria for pharmaceutical development and to use the concepts of quality by design to create scalable, reliable upstream procedures. Expertise in using statistical software (JMP, R, etc.) for DOE, tracking and trending data, and data presentation in project teams. BENEFITS Hybrid Flexibility (3-4 days) Unlimited PTO 401k & Stocks Medical, Dental, Vision, Insurance MUCH More!

US$120001 - US$170000 per year
Boston
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Manager, Analytical Development - Medical Devices

Manager, Analytical Development - Medical Devices Location: Boston Working situation: On-Site Level: Manager Our client is a medical device company pursuing research into exciting combination products and therapies looking for a Manager Analytical Development with a passion for curing and enhancing lives of patients. As the Analytical Development Manager, you will be a key architect in ground breaking R&D research. The ideal candidate for this role has experience supporting materials science/biomaterials and using analytical testing techniques common in solid state chemistry. As the Manager, Analytical Development - Medical Devices, you will: Develop and execute a visionary analytical development strategy aligned with mission and goals, driving the firm closer to commercialization Define and plan out strategies for mid- to late -stage development in the drug product lifecycle Harness your mastery in Analytical Tech Transfer, Validation, HPLC, Spectroscopy, Stress Testing, and other specialized analytical development techniques Leverage your proficiency in supporting large molecules/biologics Lead cross-functional project teams of 2-4 scientists and engineers to drive and execute CMC development plans Partner with CMC and Quality, to support cGMP manufacturing As the Manager, Analytical Development - Medical Devices, the ideal qualifications are: Bachelor's Degree with 10+ years of experience, OR Master's Degree with 8+ years of experience, OR Ph.D. with 6+ years of industry experience Experience in contributing to CMC efforts from Phase I to Phase III (desired) Experience with specialized analytical techniques like: DSC, spectroscopy, microscopy, stress/strain testing for medical devices or combination products Company Benefits: Competitive 401K program, health insurance, and HSA accounts Long term incentives in the terms of equity or stock at this level Working at a Top 50 places to work on LinkedIn If you are interested, please apply by clicking here.

US$150000 - US$170000 per annum
Boston
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Senior EMC Test Engineer

Senior EMC Test Engineer Location: Baden-Wรผrttemberg, Germany Company: Our client is a reputable Notified Body company specialising in Medical Device and Automotive sectors. Role Overview: We are seeking an experienced Senior EMC Test Engineer to join our clients team. The successful candidate will be based at a state-of-the-art facility located in the beautiful region of Baden-Wรผrttemberg. As a Senior EMC Test Engineer, you will play a crucial role in ensuring compliance with international product safety standards for medical devices (such as IEC60601 series) and automotive equipment (CISPR 25). Qualifications: Degree or equivalent experience within Electrical Engineering. Familiarity with international product safety standards such as IEC60601 series for medical devices and CISPR 25 for automotive equipment. C1 German Skills: The ideal candidate should possess the following skills: Experience conducting Electromagnetic Compatibility (EMC) testing on products subject to regulatory compliance requirements. Knowledge of Electrostatic Discharge (ESD), Radiated Emissions (RS)/Radiated Susceptibility (RN). Understanding of environmental simulation tests, including temperature/humidity cycling and vibration/shock. Experience with High voltage & Low voltage testing experience Responsibilities: As our clients new Senior EMC Test Engineer, you'll have responsibility over: Designing test plans and procedures that adhere to relevant regulations and standards. Conducting routine technical activities related to standardising procedures and testing practices. Preparing reports documenting findings during each phase of testing. Leading meetings and engagement with global clients If this sounds like your dream job, send us your CV today! Apply now and join our clients dynamic team in Baden-Wรผrttemberg

Negotiable
Baden-Wรผrttemberg
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Sr. Analytical Scientist

Senior Scientist - Analytical Development Location: Baltimore, MD Working situation: On-site Level: Senior Scientist Our client, a growing pharmaceuticals firm, is working to produce innovative drug therapies with multiple products in pipeline from pre-clinical to the commercialization stage. With a focus in pioneering therapies that address unmet medical needs, our client is proud of their continuous dedication to research and development. As they expand their portfolio and enter new therapeutic areas, we are seeking a highly skilled and motivated individual to join their team. The Senior Scientist - Analytical Development will lead a project team, by providing expertise in analytical development for intermediate and active pharmaceutical ingredient manufacturing operations, from all phases of the drug development cycle. You be a leader on the analytical development team, overseeing the design, optimization, and validation of analytical methods crucial for characterizing drug candidates and ensuring their quality and safety. Your expertise will drive the successful progression of drug development programs, making a significant impact on patients' lives worldwide. The Senior Scientist - Analytical Development will: Supervise molecule characterization, method validation, method development, and method transfer ensuring drug efficacy Define and plan out strategies for early- to late-stage development in the drug product lifecycle Develop and optimize a wide range of analytical methods, such as chromatography, mass spectrometry, spectroscopy, and others, for the characterization of drug substances and drug products Lead cross-functional project teams to drive and execute CMC development plans Work closely with the regulatory affairs team to prepare and review sections of regulatory submissions related to generics projects, supporting investigational new drug (IND) applications and new drug applications (NDAs). Partner with CMC and Quality, to support cGMP manufacturing The Senior Scientist - Analytical Development has the following qualifications: Master's degree with 6+ years of industry experience 4+ years of experience in contributing to CMC efforts from Phase I to Phase III (desired) 3+ years of experience in small molecule analytical development (desired) Company Benefits: Excellent PTO package Inviting and vibrant team culture Long term incentives in the terms of equity or stock at this level Competitive 401K program, health insurance, and HSA accounts If you're fuelled by a burning passion for innovation, a relentless pursuit of analytical excellence, and a desire to constantly push the limits of drug development, we invite you to seize the opportunity and apply for this exceptionally rewarding position today!

US$100000 - US$110000 per annum
Baltimore
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Scientist, Protein Engneering

We are seeking a Scientist/Senior Scientist to join our research team, responsible for overseeing, executing, and coordinating activities within the lab. This role requires extensive expertise in antibody-based therapeutics, protein engineering, molecular biology, purification, and characterization. Key Responsibilities: Contribute to the engineering of novel biologic drugs, focusing on therapeutic multi-specific antibodies and Antibody Drug Conjugates (ADCs). Utilize structural and sequence analysis tools such as Pymol, Chimera, IgBlast, Discovery Studio, abYsis, and Geneious to guide protein and expression plasmid design. Assist in candidate optimization, selection, and validation of stability and critical drug-like properties. Perform cloning, mammalian cell line expression, purification, and characterization of protein constructs, with a focus on potential post-translational modification (PTM) sites. Develop comprehensive protein engineering strategies to enhance antibody stability under various physiological conditions. Generate homology models and evaluate properties via in silico simulation. Conduct protein analytics including biolayer interferometry, dynamic light scattering, SDS-PAGE, and HPLC. Write and review Standard Operating Procedures (SOPs) for regulatory compliance and laboratory operations. Collaborate with other divisions to advance company goals. Coordinate with R&D and manufacturing departments in China, accommodating meetings and providing technical support. Qualifications: Strong scientific background in structural biology, molecular biology, biochemistry, protein purification, and characterization. Previous experience in therapeutic antibody engineering is essential. If you meet these qualifications and are eager to contribute to cutting-edge research in biotechnology, we invite you to apply for this exciting opportunity. Join us as we work towards advancing novel therapies for the benefit of patients worldwide. Benefits: Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include: Medical Insurance Dental Insurance Vision Insurance Employer-Paid Basic Life Insurance Supplemental Life Insurance Employer-Paid Short-Term Disability Long-Term Disability 401(k) Plan Paid Time Off Paid Holidays

US$150000 - US$170000 per year
Washington
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Senior Director, Protein Engineering

We are seeking a highly skilled Senior Director, Protein Engineering to lead our team of scientists in the design, engineering, and characterization of antibody-based drug candidates, including ADCs, bispecific, and multi-specific antibodies. Key Responsibilities: Lead innovation and core platform processes within the protein engineering department. Manage resources to support new drug development technologies and R&D initiatives related to protein design and production. Drive the engineering of novel therapeutic multi-specific antibodies and ADCs, identifying and mitigating risks in protein engineering projects. Utilize structural and sequence analysis to inform the design of drug candidates. Oversee optimization, quality validation, and stability studies of drug candidates. Contribute to regulatory filings of biotherapeutics and prepare reports, papers, and patent applications in collaboration with inventors, scientists, and legal counsel. Facilitate communication and technical support with the R&D center in China. Provide strategic advice and expertise to management, the board, advisory groups, and scientific committees. Manage departmental budgets, allocate resources efficiently, and ensure cost-effectiveness. Mentor and develop a high-performing team, fostering innovation, collaboration, and continuous learning. Engage in strategic planning, setting research priorities, and advancing drug development pipelines. Oversee multiple projects, set timelines, and ensure timely delivery of objectives. Implement quality management systems, ensure compliance, and drive continuous improvement. Represent the company externally, engage with key opinion leaders, and present scientific findings. Qualifications: Proven track record of leadership in protein engineering and therapeutic antibody development. Strong background in structural and sequence analysis. Excellent communication and collaboration skills. Advanced degree in a relevant scientific field. Minimum of [10] years of experience in biopharmaceutical research and development. If you meet these qualifications and are ready to make a significant impact in the field of biotechnology, we encourage you to apply. Join us in our mission to develop innovative therapies that improve patient lives. Benefits: Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include: Medical Insurance Dental Insurance Vision Insurance Employer-Paid Basic Life Insurance Supplemental Life Insurance Employer-Paid Short-Term Disability Long-Term Disability 401(k) Plan Paid Time Off Paid Holidays

US$250000 - US$280000 per year
Washington
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Sr. Director Antibody Engineering and Drug Discovery

Join our innovative team, where we're pioneering groundbreaking advancements in therapeutic antibody development. We're seeking a dynamic individual to lead our efforts in antibody engineering, driving our programs towards success. The individual we are seeking will have extensive knowledge in antibody generation, employing various technologies like hybridoma, single B-cell screening, and phage display. Demonstrated proficiency in developing bispecific and multi-specific antibody formats. Experience in designing and executing plate-based and cell-based screening assays. Knowledge of conducting developability and manufacturability assessments for antibody selection and optimization. Familiarity with utilizing bioinformatics tools for sequence and structure analysis. Proven leadership abilities, including mentoring and leading teams in therapeutic antibody development. Ability to thrive in a fast-paced, collaborative project team environment, adept at meeting deadlines and managing multiple projects. Excellent written and verbal communication skills. Key Responsibilities: Spearhead the development of antibodies, including bispecific and multi-domain variants, for therapeutic applications. Employ diverse strategies for antibody discovery, such as hybridoma screening, B-cell screening, and phage display, to identify and optimize top candidates. Utilize protein engineering techniques to create biologics with desirable properties, leveraging molecular biology, computational, and structure-guided approaches. Provide leadership and mentorship to a team of scientists focused on antibody engineering and molecular biology. Collaborate closely with cross-functional teams in drug discovery, including immunology, process sciences, and preclinical pharmacology, to advance our pipeline of candidates. Drive technology development in antibody engineering, contributing to the expansion of our intellectual property portfolio. Recruit, manage, and develop a team of scientists and research associates, fostering a culture of creativity, excellence, and collaboration. Develop and oversee operating budgets to ensure efficient resource utilization. If you're passionate about cutting-edge science and making a meaningful impact in the field of biotechnology, we invite you to join us on our journey. Apply now to be a part of our dynamic team! Benefits: Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include: Medical Insurance Dental Insurance Vision Insurance Employer-Paid Basic Life Insurance Supplemental Life Insurance Employer-Paid Short-Term Disability Long-Term Disability 401(k) Plan Paid Time Off Paid Holidays

US$225000 - US$250000 per year
United States of America
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Head of Product Development and Innovation (m/f/d)

As Head of the Technical department, Development and Innovation, you will report directly to the Executive Board and be responsible for the projects and employees of the entire division. โ€‹ Key Responsibilities: โ€‹ Application and acquisition of funding for research and development Further development and optimisation of existing products and technologies Analysis of customers and market requirements, technical clarification with customers and suppliers Development of new products and technologies up to series production Planning of project structures and organizations with internal and external partners Applying for and maintaining appropriate patent protection, competition and patent monitoring Approvals of new products with a focus on CE, NMPA and FDA Preparation, monitoring and adherence to budget plans of the responsible departments Efficient planning, coordination and management of the development project portfolio โ€‹ Key Requirements: โ€‹ You are a visionary, assertive and at the same time down-to-earth leader with a degree in the natural sciences At least 8 years of professional and management experience in research and development work in the field of medical technology Strategic vision with emphatic leadership skills, ability to work in a team and in-depth knowledge of modern project management methods including development tools Knowledge of regulatory requirements (MDR, FDA, NMPA, DIN EN ISO 13485, DIN EN ISO 14971) A high degree of initiative and motivation Analytical way of thinking, independent and decisive way of working A friendly, confident and consistent manner in communication with the necessary tact Confident handling of MS Office Very good written and spoken German and English skills โ€‹ This role offers: โ€‹ Varied and responsible work in an innovative and future-oriented company Independent area of responsibility Exchange on an equal footing Collegial support culture Short decision-making processes due to a flat hierarchy 30 days of vacation per year Company car for private use โ€‹

Negotiable
Germany
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Senior R&D Chemist

Senior Chemist - Analytical Development Location: Orange County, CA Level: Senior Chemist SUMMARY As a Senior Chemist - Analytical Development for our global company, you will play a pivotal role in ensuring the quality, safety, and efficacy of our products. Working within a dynamic team of R&D experts, you will lead the development and optimization of analytical methods of novel small molecule therapeutics and APIs while working with quality control and our drug product development team. Your contributions will directly impact the advancement of our life-saving pharmaceutical products from discovery research to commercialization. A Senior Chemist - Analytical Development will have these responsibilities: Design and execute validation protocols for analytical methods in accordance with regulatory guidelines (e.g., ICH, FDA) to ensure accuracy, precision, specificity, and robustness. Develop and validate methods using a range of analytical techniques and instrumentation, such as HPLC, GC, LC-MS, FTIR, NMR, and dissolution testing Analyze and characterize raw materials and finished drug products. Plan and conduct stability studies to assess the stability of drug substances and products under various storage conditions, ensuring compliance with regulatory requirements. Experience with statistical data analysis and software tools (e.g., JMP, ChemStation) for method validation and optimization. Staying updated with global regulatory guidelines and ensure that analytical methods meet the stringent quality standards required for regulatory submissions Oversee the troubleshooting, calibration, and qualification of analytical instruments, ensuring their accuracy and reliability in data generation A Senior Chemist - Analytical Development has the following qualifications: M.Sc. or B.Sc. w/ 4-6+ years' experience in a pharmaceutical industry Proficient experience with Method Development/Validation; HPLC, GC, UV-Vis, & Particle Size Analysis in cGMP setting Additional experience preferred: regulatory filing experience BENEFITS Annual Bonus Competitive 401k with company matching Medical, Dental, Vision If you're interested in this new and innovative opportunity, please apply by clicking here.

Negotiable
Tustin
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Senior R&D Chemist

Senior Chemist - Analytical Development Location: Orange County, CA Level: Senior Chemist SUMMARY As a Senior Chemist - Analytical Development for our global company, you will play a pivotal role in ensuring the quality, safety, and efficacy of our products. Working within a dynamic team of R&D experts, you will lead the development and optimization of analytical methods of novel small molecule therapeutics and APIs while working with quality control and our drug product development team. Your contributions will directly impact the advancement of our life-saving pharmaceutical products from discovery research to commercialization. A Senior Chemist - Analytical Development will have these responsibilities: Design and execute validation protocols for analytical methods in accordance with regulatory guidelines (e.g., ICH, FDA) to ensure accuracy, precision, specificity, and robustness. Develop and validate methods using a range of analytical techniques and instrumentation, such as HPLC, GC, LC-MS, FTIR, NMR, and dissolution testing Analyze and characterize raw materials and finished drug products. Plan and conduct stability studies to assess the stability of drug substances and products under various storage conditions, ensuring compliance with regulatory requirements. Experience with statistical data analysis and software tools (e.g., JMP, ChemStation) for method validation and optimization. Staying updated with global regulatory guidelines and ensure that analytical methods meet the stringent quality standards required for regulatory submissions Oversee the troubleshooting, calibration, and qualification of analytical instruments, ensuring their accuracy and reliability in data generation A Senior Chemist - Analytical Development has the following qualifications: M.Sc. or B.Sc. w/ 4-6+ years' experience in a pharmaceutical industry Proficient experience with Method Development/Validation; HPLC, GC, UV-Vis, & Particle Size Analysis in cGMP setting Additional experience preferred: regulatory filing experience BENEFITS Annual Bonus Competitive 401k with company matching Medical, Dental, Vision If you're interested in this new and innovative opportunity, please apply by clicking here.

Negotiable
Tustin
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Analytical Scientist - Solid State Characterization

Scientist - Analytical Development Location: Orange County, CA Level: Scientist SUMMARY As a Scientist, Analytical Development for our global company, you will play a pivotal role in ensuring the quality, safety, and efficacy of our products. Working within a dynamic team of R&D experts, you will lead the development and optimization of analytical methods of novel small molecule therapeutics and APIs while working with quality control and our drug product development team. Your contributions will directly impact the advancement of our life-saving pharmaceutical products from discovery research to commercialization in a global capacity. A Scientist - Analytical Development will have these responsibilities: of pharmaceutical materials with analytical techniques such as PAS, XRD, DSC, etc. on particle size distribution and crystallography to assess solid state chemistry of the materials. and execute validation protocols for analytical methods in accordance with regulatory guidelines (e.g., ICH, FDA, USP) to test purity and stability. a range of analytical techniques and instrumentations to analyze and characterize raw materials and finished drug products. wet chemistry techniques and different assays for the physical and chemical characterization of APIs, raw materials, and drug products. and conduct release and stability studies to assess drug substances and finished products under various storage conditions, ensuring compliance with regulatory requirements. updated with global regulatory guidelines and ensure that analytical methods meet the stringent quality standards required for regulatory submissions. A Scientist - Analytical Development has the following qualifications: Ph.D., M.Sc., or B.Sc. w/ 3-8+ years' experience in a pharmaceutical industry Proficient experience with solid-state chemistry, PAS, XRD, method development, method validation, & method transfer Additional experience in regulatory filing is a plus BENEFITS Bonus 401k with company matching Dental, Vision If you're interested in this new and innovative opportunity, please apply by clicking here.

Negotiable
Tustin
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Sr. Product Development Engineer

Summary: A leading contract manufacturing firm based in Minneapolis, MN, is in search of a Senior Product Development Engineer. This role is focused on leading the development of catheter concepts from initial design to market release. The company, known for its innovative approach to complex catheter product development, is specifically seeking candidates with the following qualifications: Responsibilities: Spearhead the development of concepts, prototypes, processes, and products from initial design to market release. Take charge of smaller projects with clear execution paths, ensuring deliverables are met. Assist in crafting proposals for existing clients to meet new deliverables within ongoing projects. Innovate methodologies, materials, machines, processes, or products to usher concepts to market fruition, meticulously documenting product and process details. Maintain meticulous documentation throughout all research and development stages. Draft project plans outlining phases, tasks, durations, resources, and costs for basic projects. Engage in direct client meetings and maintain proactive communication within the team. Conduct risk analyses for products in development. Coordinate with external suppliers and consultants to ensure timely delivery of required supplies or services. Mentor junior engineers on technical growth and project management as needed. Lead brainstorming sessions and design reviews. Generate creative concepts for new medical device designs, meeting clinical requirements and surpassing customer expectations. Organize and execute interdepartmental activities to ensure projects are completed on schedule and within budget. Conduct feasibility studies to assess design functionality. Generate and execute protocols and reports to support validation activities, including Design Verification, IQ, OQ, PQ. Uphold standards of excellence in all Product Development processes. Fulfill any other assigned duties. Position Requirements: Education, Experience, Skills: Bachelor's degree in Mechanical or Biomedical Engineering preferred; equivalent experience may be considered. Minimum of 10 years of experience in medical device design and development. Familiarity with FDA QSR and ISO 13485 medical device regulations. Proficiency in SolidWorks 3D CAD. Knowledge of probability and statistics. Experience in catheter and extrusion design. Expertise in reinforced shaft, delivery systems, and steerable catheters design. Profound knowledge in technical areas such as laser/resistance welding. Proven ability to shepherd products from concept to market. Strong interpersonal skills for client interaction, coupled with excellent written and verbal communication skills.

US$65 - US$75 per hour
Minneapolis
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