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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Experience

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

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R&D Jobs

Senior Scientist/Principal Scientist Drug Product Development

A global pharmaceutical company is seeking a Senior Scientist/Principal Scientist to join their team to support formulation development (title/compensation dependent on years of experience, education, etc.). The candidate will be responsible for developing formulations and processes for new products in the R&D pipeline. The role will also involve communicating with CROs and internal functions to deliver project timelines. The ideal candidate will have a strong background in the pharmaceutical or biotech industry. Responsibilities Conduct or lead formulation and process development for new products in the R&D innovation pipeline. Conduct literature research supporting product development. Manage clinical supplies including shipping clinical supplies to CROs for clinical studies Communicate with CROs on routine basis regarding the retention and destruction of clinical supplies, bio samples, and original documents according to the FDA's requirements Review technical documents for clinical study permit applications. Prepare and review documents for regulatory submission to the FDA. Participate or lead the review of clinical study protocols and reports Requirements Master's degree in pharmaceutical sciences or other related scientific disciplines, Ph.D. degree will be a plus Working experience in the pharmaceutical or biotech industry Knowledge of pharmaceutical dosage forms including injectables and topicals Tableting, fluid bed processing and encapsulation skills will be a plus. Knowledge of cGMP requirements Able to communicate clearly and precisely in English, both in writing and speaking Working experience in matrixed organizations will be a plus If interested please apply!

US$110000 - US$160000 per year
New Jersey
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Quality Assurance Specialist

**Hybrid Role in Columbus. Ohio** Job opportunity with a top Biotech/Pharmaceutical company that is looking for a Quality Assurance Professional to join their team on a 6-month contract. Qualifications: BS/BA Degree in a scientific discipline. Advanced degree preferred. 5+ years experience in a related regulated industry 2+ years in a GLP or clinical laboratory Quality Assurance or Quality Control role. Technical knowledge of nonclinical GLP studies and bioanalytical and clinical test method validations Job Description/Skills: Conduct protocol and protocol amendment reviews, in-study inspections, and data and report audits for nonclinical, method validation, and clinical sample testing studies for compliance to applicable regulations (GLP, GCP), methods, and SOPs. Perform facility inspections to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with GLP regulations. Review other controlled documents, e.g., Test Methods, and select SOPs and Policies, as requested by Testing Facility Management. Review of quality events associated with the site GLP activities including deviations, investigations, CAPAs, quality metrics. Support internal, Sponsor or regulatory inspection activities at the OH site. Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?

Negotiable
Columbus
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Quality Assurance Specialist

**Hybrid Role in Allentown, PA** Job opportunity with a top Medical Device company that is looking for a Quality Assurance Professional to join their team on a 12-month contract to hire. Qualifications: BS/BA Degree in a scientific discipline. 3+ years of experience with a Scientific background and/or experience in a GMP/GLP lab setting. Microbiology/Chemistry background preferred. Job Description/Skills: Provide Quality oversight over the Quality System, including but not limited to the review SOPs, protocols, reports, data (including meta data) and records generated to support the manufacturing and distribution of product. Conducts timely Quality review of associated data, including data utilized to product release Assists in complying with regulatory requirements related to product safety and quality. Ensures that procedures are being followed as outlined under FDA, ICH, Standard Methods and the Quality System requirements. Review records to ensure data meets the industry requirements for data integrity. Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?

Up to US$40 per hour
Allentown
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Analytical Scientist, Drug Product Development

*Onsite Role in New York* A Pharmaceutical R&D company is looking for an Analytical Scientist, Formulation Development to join their team in New York. The successful candidate will be responsible for developing analytical methods for drug molecules and finished products. They will also collaborate with the formulation team to review data and interpret results. Responsibilities Develop analytical HPLC methods for drug molecules and finished products by applying analytical Quality by Design (QbD) approach (assay, stability, etc.) Validate analytical methods using High Performance Liquid Chromatography (HPLC) Testing and analysis of samples using High Performance Liquid Chromatography (HPLC) Assure that all the processing and testing equipment is in calibration and organize the qualifications/calibrations of equipment as per approved procedures Skills Experience with HPLC methods development and validation Knowledge of analytical Quality by Design (QbD) approach Experience in pharmaceutical industry and formulation development Excellent problem-solving and communication skills Ability to work independently and in a team environment Qualifications: Master's degree in Pharmaceutical Science or related field

US$90000 - US$120000 per year
New York
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Formulation Scientist

*Onsite Role in New York* A Pharmaceutical R&D company based in New York is looking for a Formulation Scientist to join their team. The successful candidate will be responsible for the development and optimization of several products with different delivery dosages. Responsibilities - Perform various pre-formulation studies such as solubility, compatibility, degradation study for active pharmaceutical ingredients and for raw materials. - Design formulation trials by applying Design of Experiment (DOE) and Quality by Design QbD tools. - Conduct physio-chemical characterization of transdermal/topical semisolid formulations such as morphology/crystallization, particle size distribution, pH, viscosity, rheological characteristic, texture analysis, cold flow, IVRT and IVPT studies. - Prepare reports and recommendations based upon research outcomes to transfer products to external organizations - Conduct stability studies of optimized novel and topical formulations - Review patents and research articles Skills - Masters or Ph.D. in Pharmaceutical Sciences or related field - Experience with Design of Experiment (DOE) and Quality by Design QbD tools - Data analysis and report preparation - Experience on 505(b)2 drug approval pathway If interested please apply below!

US$90000 - US$120000 per year
New York
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Method Validation Engineer

**Onsite Role in Thousand Oaks, CA** Job opportunity with a top biopharmaceutical company that is looking for a Method Engineer to join their team on a 6-12 month contract with a possibility for conversion or extension! Pay Rate: $45-$50/hr Qualifications: Bachelor's Degree or superior 5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices Familiar with ICH Q2 method qualification/validation requirements Job Description/Skills: Plan, prioritize, execute, and implement analytical assays Support QC method technical transfers Develop validation protocols for QC analytical instruments Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?

US$45 - US$50 per hour
Los Angeles
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Scientist/ Senior Scientist: Formulation Development CMC

Scientist/ Senior Scientist: Formulation Development CMC Location: Baltimore, Maryland area Salary: $100,000 - $135,000 + bonus + benefits A small biotech in the Baltimore area is looking to expand their CMC Drug product and Process Development team. They are a current developer of a healthcare technology platform that is focusing on oncology/ immunology with the help of cell therapy. Their pipeline consists of 4 ongoing trials with three programs in the clinical with one heading into late stage. The ideal candidate has prior experience in biologics involving formulation and drug product efforts. Responsibilities: Contributing to their pipeline programs while working cross functionally with other teams Experience in early and late stage formulation development Collaborating with team to meet deadlines and on time deliverables. Hands on experience with T- Cells and IND enabling cell therapy. Qualifications: M.S in Pharmaceutical Sciences or related field with 2+ years of industry experience Prior experience working in a team- based environment Strong understanding of IND enabling cell Therapy Familiar with biologics involving the clinical stages of development Experience in working cross functionally with other R&D teams is highly valued Exceptional communication and problem solving skills.

US$100000 - US$130000 per year
Maryland
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Scientist - Drug Product/ Analytical Development CMC

Scientist/ Senior Scientist | Drug Product Development/Analytical Development | CMC Location: Greater New York Area Salary: $100,000 - $130,000 + bonus + benefits A new state of the arts CDMO in the greater New York area is expanding their CMC Drug Product and Analytical Development team. This role would be a great way to gain experience in multiple dosages and different stages of development as they will be working on multiple projects ranging from phase I to phase III with exposure to different dosage forms. An opportunity like this is beneficial for scientists looking to enhance their industry experience while being exposed to multiple dosage forms. Responsibilities Assist in leading and Contributing to the CMC Drug Product Development or Analytical team. Working with a small molecule portfolio ranging from phase I to phase III. Working Cross functionally with additional CMC departments such as other R&D teams Oversee project timelines to ensure on time deliverables from the team. Hands on experience with different dosage forms primarily injectables Requirements: MS in Pharmaceutical Sciences or related field with 3+ years of industry experience Excellent communication, problem-solving, and project management skills Ability to work in a fast-paced environment. Strong background in small molecule early and late-stage product development Expertise in working cross functionally with the Process Development team is highly valued. Previous experience with injectables is highly valued/ considered Strong understanding of HPLC

Negotiable
New York
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Director of Drug Product Biologics

Job Title: Director of Drug Product: Biologics Location: Boston, MA I am partnered with a leading pharmaceutical company dedicated to advancing innovative biologics that address critical medical needs. Qualifications: Minimum of 8 years of industry experience in drug product development for biologics Ph.D. in Pharmaceutical Sciences or related field preferred, Master's degree in Pharmaceutical Sciences considered Extensive experience in managing and leading cross-functional teams Proven track record in successful tech transfer activities Strong understanding of regulatory requirements for biologics drug development Excellent communication and leadership skills Local to the Boston area or willing to relocate on your own Responsibilities: Lead and oversee the successful execution of tech transfer activities for biologics drug products. Collaborate with internal and external stakeholders to ensure a seamless transition of processes and knowledge. Foster a collaborative and innovative work environment that encourages professional growth and development. Ensure compliance with regulatory requirements and industry standards in all drug product development activities. Contribute to the development of the overall drug product development strategy. Provide leadership in identifying and implementing innovative approaches to enhance drug product development processes. If interested please reach out to my email:

Negotiable
Cambridge
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Principal Scientist, Drug Product Development

Working with a global pharmaceutical company looking to enhance their CMC team, primarily within their late-stage portfolio. Their looking to bring on Scientists who have experience with Biologics and are looking to gain exposure with late-stage programs & will also have access to CGT programs. Responsibilities Lead development team for late-stage formulation efforts for Biologics (different modalities) Interpret raw data, organize results, generate/review reports, and communicate findings to internal teams Will oversee tech-transfers, scale-ups, and outsourced formulations Help design effective CMC program strategy alongside internal functions Will primarily work on late-stage programs (including CGT) Qualifications M.S. degree with ideally 8+ years of relevant experience is required, Ph.D. preferred Expertise in drug delivery systems, Bio-pharmaceutical dosage forms, and technology transfer through demonstrated experience Experience authoring CMC sections for IND, BLA & MAA is highly sought after Proven leadership and communication skills Late stage experience is highly sought after

US$140000 - US$170000 per year
Pennsylvania
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Director of Drug Product Development

A clinical stage biotechnology company focused on creating novel therapies is looking to hire a highly motivated Director of Drug Product Development. This individual will be responsible for development activities leading to commercialization. The position will report to the Senior Director of Drug Product Development. This role will require cross-functional collaboration with internal and external stakeholders to ensure the execution of CMC activities. Responsibilities Advance new innovations to commercialization stage Lead all formulation activities (preformulation, process development, scale-up, tech transfer) related to solid oral dosage and parental forms Develop and integrate innovative strategies to streamline CMC processes Travel to external partners as needed Qualifications Ph.D. or M.S. in Pharmaceutical Sciences, Pharmaceutics, chemistry, Chemical Engineering or related field 15+ years of experience in pharmaceutical/bio tech industry with proven leadership capabilities Technical expertise across all stages of drug development and experience with small molecule formulation Thorough understanding of GMP requirements and FDA, EMA regulatory filings Team-player mentality and strong communication skills

US$190000 - US$225000 per year
Pennsylvania
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Director of Formulation Biologics

Director of Formulation Biologics Location: Greater Boston Area Salary: $200,000 - $230,000 + bonus + excellent benefits A local innovative Biotech is looking to hire a Director to help lead their CMC Formulation team. This person will report into the Senior Director of Drug Product Development and will work closely with team members to assist with the creation and execution of large-molecule programs. This opportunity allows for fast career progression potential with the chance of being one of the leaders in terms of the strategic direction of the team. The ideal candidate will have minimum 8 years of industry experience and will have worked closely with injectables and mAbs. Responsibilities: Partner with CMC and Quality teams to bolster cGMP manufacturing. Collaborate cross-functionally with R&D, Regulatory & Manufacturing to execute product development strategy. Lead and guide a team of 2-5 Formulation Scientists while cultivating a strong performance work atmosphere Collaborate and coordinate with external partners, acting as the primary point of contact Requirements: Background in Biologics & injectables. Experience in both early and late-stage development is preferred. Ph.D. in Pharmaceutical Sciences with a minimum of 6 years industry experience or MS in Pharmaceutical Sciences with a minimum of 10 years industry experience. Experience working on regulatory filings, specifically IND's & BLA's. Ability to effectively set priorities, handle multiple projects and follow-through on deadlines with minimal supervision. A keen attention to detail and the ability to thrive in a fast-paced environment. If interested, please apply in directly.

US$200000 - US$230000 per year
Massachusetts
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