Associate Scientist Analytical/QC Testing
Summary: Our firm is partnered with a rapidly expanding biotech company to support their growth in Analytical Development & Quality Control (QC). This innovative & "people-first" organization is at the forefront of cutting-edge research and development for underserved therapeutic areas, and we're proud to assist them in building a world-class team. Seeking motivated and skilled Associate Scientists with experience in Analytical/QC Testing for small molecule API's & solid oral drug products to contribute to 2025 milestones. Key Responsibilities: Conduct laboratory activities with minimal supervision, including analyzing raw materials, in-process materials, and finished pharmaceutical products for quality, safety, purity, strength, and identity. Independently set up and operate lab equipment, prepare reagents, solvents, and solutions for analytical and formulation activities. Maintain accurate records in lab notebooks and process analytical data using lab equipment such as HPLC/UPLC. Support the manufacture of small molecule drug products and prepare samples for blend uniformity. Perform equipment qualification and calibrations as directed. Execute approved method transfer protocols. Assist in training other scientists and perform additional tasks as assigned. Participate in project activities, support project timelines, and contribute to team objectives. Establish and maintain effective relationships with team members. Conduct lab work in accordance with SOPs & STPs, following corporate safety rules and procedures. Comply with all corporate guidelines and policies. Qualifications: Bachelors in Chemistry, Pharmacy, or related fields with at least 3 years of experience in Pharmaceutical R&D, or M.S. with 1-2 years of experience in the Pharmaceutical industry. Proven ability and/or experience with compendial test methods or pharmaceutical manufacturing equipment. Understanding of pharmaceutical equipment and computerized systems for operation and troubleshooting. Specific experience with analytical and/or process equipment used in laboratories such as HPLC, IR/FTIR, UV-Vis AA, powder blender, etc. Experience with Empower software Knowledge and understanding of FDA cGMP requirements as they apply to the pharmaceutical industry. Effective English written and oral communication skills, with the ability to write short technical documents such as memos, laboratory investigations, protocols, and reports. Additional: Cannot provide sponsorship Competitive Benefits including 401k match, Target Annual Bonus, & Combined Holiday/PTO Relocation assistance available! Health, Medical, & Dental Insurance plans take effect right away!
US$60000 - US$90000 per year
Florida
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Project Manager R&D
Product Project Manager / R&D Project Manager Netherlands | ๐ Full-time We're looking for a Product Project Manager to lead implant and ancillary development projects, coordinate cross-functional teams, and ensure regulatory compliance. Your Role: Manage medical device development projects and technical documentation (DHF, DMR, STED). Coordinate teams across R&D, QA/RA, production, and marketing. Oversee regulatory compliance (including MDR and 510(k) submissions). Drive process improvements and technical support. Your Profile: Master's in medicine, biomechanics, or bioengineering. 5+ years in medical devices, ideally implantable prostheses. Strong regulatory knowledge and project management skills. Fluent in French & English (German is a plus). Join us and make an impact in medical innovation! Apply now!
Negotiable
Switzerland
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R&D Engineer
R&D Engineer - Netherlands We are looking for an R&D Engineer to join the Product Engineering team. Reporting to the Product Engineering Team Leader, you will contribute to new product development, manufacturing processes, and continuous improvement initiatives. Key Responsibilities: Develop new products and manufacturing processes. Support CAD design (fixtures, instruments, implants), FEA analyses, and cross-functional collaboration. Plan and execute verification and validation tests. Manage the R&D laboratory and assist in prototype production. Draft technical documentation (DHF) and contribute to risk analysis. Provide technical support for subcontractors and ensure design for manufacturing best practices. Your Profile: Hands-on, problem-solving mindset with strong multitasking abilities. Detail-oriented, autonomous, and collaborative. Fluent in French and English (German is a plus). Experience in regulated environments (ISO 9001, ISO 13485). If you're passionate about innovation and eager to make an impact, apply now!
Negotiable
Schweizer-Reneke
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Analytical Scientist/ Sr Scientist
Position: Analytical Development Scientist III/ Sr. Scientist Location: Newark, CA Company Overview: This biotech company is at the forefront of innovative biotechnology. They are dedicated to transforming the lives of patients through groundbreaking advancements in biologics. Join thier dynamic team and be part of a company that values scientific excellence, collaboration, and continuous improvement. They offers a collaborative and innovative work environment where your contributions will make a significant impact. If you are passionate about scientific discovery and eager to advance your career in biotechnology, we invite you to apply and join the team of dedicated professionals. Position Summary: They are seeking a talented Scientist to join thier expanding Analytical Development team. This role is integral to their mission of developing and validating cutting-edge analytical methods for the characterization of complex biologics. The Scientist will play a key role in supporting clinical programs, commercial registration, and post-approval enhancements for Revance projects. Responsibilities: Develop, validate, and execute sophisticated analytical methodologies to support the characterization of biologics. Author and review technical documents, including analytical methods, protocols, reports, and instrument qualifications. Operate and maintain advanced analytical instrumentation and computer control systems. Collaborate cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical teams to provide comprehensive analytical testing support. Contribute to the continuous improvement of technical operations and project outcomes within the Analytical Development area. Support laboratory operations, including inventory tracking, reagent preparation, sample management, and documentation review. Ensure compliance with ICH guidelines and global regulations in the execution of analytical and biological methods. Adhere to GMPs, GLPs, GCPs, and GDPs as required. Requirements: Extensive experience with analytical assay techniques such as absorbance assays, chromatography, CE-SDS, ELISA, and western blot. Proficiency in interpreting data from characterization techniques like AUC, LC/MS, MFI, DLS, and CD. Strong background in developing and authoring protocols, methods, and SOPs. Excellent communication skills, both written and verbal, with the ability to collaborate effectively across technical and operational activities. Working knowledge of statistics and familiarity with tools like R or Python. Demonstrated ability to manage multiple projects simultaneously with strong organizational and problem-solving skills. Self-motivated and proactive, with a keen interest in experimental design and development. Knowledge of GMPs, GLPs, GCPs and GDPs regulations. Preferred Experience: Expert-level proficiency in Liquid Chromatography and Immunoassays. Experience in drafting protocols, methods, and procedures. Knowledge or experience with neurotoxin therapeutics. Familiarity with change control, deviation, laboratory investigation, and other quality records. Education: Advanced degree in biological sciences or a related field with 5+ years of progressive experience in the biotechnology or pharmaceutical industry.
Negotiable
Newark
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Scientist II Analytical
Summary: Join this innovative team and fast growing Biotech dedicated to advancing pharmaceutical research and development. Seeking a motivated and skilled Scientist with experience developing analytical methods for small molecule drug products to contribute to 2025 milestones. Key Responsibilities: Conduct laboratory activities & lead projects with minimal supervision, including analyzing raw materials, in-process materials, and finished pharmaceutical products for quality, safety, purity, strength, and identity. Independently set up and operate lab equipment, prepare reagents, solvents, and solutions for analytical and formulation activities. Maintain accurate records in lab notebooks and process analytical data using lab equipment such as HPLC/UPLC. Support the manufacture of small molecule drug products and prepare samples for blend uniformity. Perform equipment qualification and calibrations as directed. Execute approved method transfer protocols. Assist in training other scientists and perform additional tasks as assigned. Participate in project activities, support project timelines, and contribute to team objectives. Establish and maintain effective relationships with team members. Conduct lab work in accordance with SOPs & STPs, following corporate safety rules and procedures. Comply with all corporate guidelines and policies. Qualifications: Masters in Chemistry, Pharmacy, or related fields with at least 6-8 years of industry experience, or Ph.D. with 2-3 years of experience in the Pharmaceutical industry. Proven ability and/or experience with compendial test methods or pharmaceutical manufacturing equipment. Understanding of pharmaceutical equipment and computerized systems for operation and troubleshooting. Specific experience with analytical and/or process equipment used in laboratories such as HPLC, IR/FTIR, UV-Vis AA, powder blender, etc. Experience with Empower software Knowledge and understanding of FDA cGMP requirements as they apply to the pharmaceutical industry. Effective English written and oral communication skills, with the ability to write short technical documents such as memos, laboratory investigations, protocols, and reports.
US$90000 - US$120000 per year
Florida
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Field Evaluations Engineer
Field Evaluation Engineer Location: Greater Los Angeles/Southern California (Mandatory) We are looking for a skilled Field Evaluation Engineer to join our team. This role offers an exciting opportunity to work in a dynamic and fast-paced environment, ensuring product safety and compliance through field evaluations. The ideal candidate will have strong expertise in electrical standards and a commitment to excellence in safety assessments. Primary Responsibilities: Perform field evaluations and testing to verify compliance with industry standards, including UL 891, NFPA, IEEE, NSF, SPE-1000, NEC, and ANSI. Assess and document findings while providing clear recommendations for compliance. Work efficiently to meet deadlines while maintaining high-quality standards. Communicate technical information effectively to both internal teams and clients. Required Qualifications: Demonstrated experience in field evaluations for electrical product safety compliance. Strong problem-solving skills with a customer-centric approach. Excellent verbal and written communication abilities. Bachelor's degree in Electrical, Electronic, Electromechanical, Mechanical Engineering, or a minimum of 7 years of hands-on experience in commercial/industrial electrical work. Fluency in English, both written and spoken. Willingness to travel up to 50%, including out-of-state assignments. Flexible availability, including occasional nights and weekends. Ready to begin work immediately in a full-time capacity. What We Offer: Be part of a progressive team dedicated to industry advancements in safety and compliance. Work in an environment that values collaboration and professional growth. Engage in impactful projects that contribute to industry-leading safety standards. Additional Information: Candidates must be based in the Greater Los Angeles/Southern California region and be willing to travel as needed. Flexibility with work hours is required.
Negotiable
California
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Lead Scientist (Study Director)
OPEN TO RELOCATING CANDIDATES! Our client is a global leading CDMO that is currently looking for a Lead Scientist to be part of their viral clearance team. As the Lead Scientist, you will be the subject matter expert, designing and leading projects. Key Responsibilities: Oversee all aspects of study planning, execution, analysis, documentation and reporting Design studies and conduct laboratory work, ensuring they are aligned with the guidelines, protocols and GMP standards. Leading and managing project teams, working with local and global teams Build, establish and maintain relationships with internal and external stakeholders Provide clear and effective communciation through reports and meetings. Requirements: Degree/ PhD in Biological Science or relevant field of study At least 5 years of lab experience, or at least 2 years and a PhD. Viral clearance experience Biologics License Applications (BLA) study experience Good understanding of cGMP regulations and quality management Excellent communication skills If you are interested in the opportunity, please apply with your CV attached.
Negotiable
Singapore
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VP of CMC (Biologics)
Vice President of CMC Biologics Hybrid Company Overview: We are partnered with an emerging Biotechnology company focused on developing Best-in-class Therapeutics to address unmet medical needs. This leading Biopharma has several assets across multiple stages of development and are on track to hit multiple milestones H2 of this year. Job Summary: We are seeking a highly experienced and strategic leader to join our team as the Vice President of CMC (Chemistry, Manufacturing, and Controls) Biologics. The VP of CMC Biologics will be responsible for overseeing all CMC activities related to the development, manufacturing, and regulatory compliance of biologic products. This role requires a deep understanding of biologics, regulatory requirements, and the ability to lead cross-functional teams to ensure the successful development and commercialization of biologic therapies. Key Responsibilities: Develop and implement CMC strategies for biologic products from early development through commercialization. Lead and mentor a team of CMC professionals, fostering a collaborative and high-performance culture. Provide strategic direction and oversight for all CMC activities, including process development, analytical development, and manufacturing. Ensure compliance with global regulatory requirements for biologics, including the preparation and submission of CMC sections for regulatory filings (INDs, BLAs, etc.). Stay current with regulatory guidelines and industry best practices to ensure the company's CMC activities are aligned with regulatory expectations. Oversee the development and optimization of manufacturing processes for biologic products from IND-enabling to Late Stage/Commercialization Collaborate with internal and external stakeholders to resolve technical challenges and ensure the successful scale-up and transfer of manufacturing processes. Work closely with the Quality Assurance and Manufacturing teams to ensure the production of high-quality biologic products. Implement and maintain cGMP (current Good Manufacturing Practices) standards across all CMC activities. Drive continuous improvement initiatives to enhance product quality, efficiency, and compliance. Collaborate with R&D, Clinical, Regulatory Affairs, and Commercial teams to align CMC activities with overall product development and commercialization strategies. Provide CMC expertise and support to cross-functional project teams to ensure timely and successful project execution. Qualifications: Advanced degree (Ph.D. preferred) in a relevant scientific discipline (e.g., Biochemistry, Molecular Biology, Chemical Engineering). Minimum of 15 years of experience in CMC roles within the biopharmaceutical industry, with at least 10 years in a leadership position. Proven track record of successfully leading CMC activities for biologic products through all phases of development and commercialization. In-depth knowledge of regulatory requirements for biologics, including experience with regulatory submissions and interactions with regulatory agencies. Strong leadership, communication, and interpersonal skills. Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities. What We Offer: Opportunity to lead in a dynamic, fast-growing company with a strong pipeline of innovative therapies. Collaborative work environment with professional development and career growth opportunities. Competitive compensation package, including comprehensive benefits and stock options.
Negotiable
Boston
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Director, Antibody Engineering
Director, Antibody and Protein Engineering Summary of Role A leading global biopharma is seeking their next Director of Antibody & Protein Engineering. As Director, you'll head a team designing and optimizing antibodies and proteins, driving candidates from discovery to clinical development. You'll integrate advanced computational tools and structural insights to deliver high-performance molecules for unmet medical needs. Responsibilities Direct antibody and protein engineering efforts, focusing on sequence optimization, affinity maturation, and effector function tuning. Implement computational design platforms (e.g., Rosetta, Schrรถdinger) and machine learning models to predict and enhance biophysical properties like stability and solubility. Oversee structural analysis (X-ray crystallography, cryo-EM) to guide rational design and validate molecular modifications. Coordinate with discovery teams to define target profiles and with CMC to ensure manufacturability of lead candidates. Lead experimental workflows for high-throughput screening and characterization (SPR, BLI, DSC) of engineered proteins. Drive integration of novel technologies (e.g., bispecific scaffolds, Fc engineering) into therapeutic pipelines. Present data-driven insights at project reviews and external scientific forums. Qualifications PhD in Biochemistry, Structural Biology, or related field. 10+ years in antibody/protein engineering within biotech/pharma, with a focus on therapeutic development. Proven record of advancing biologics through discovery to preclinical stages (e.g., IND-enabling studies). Expert in computational protein design tools (e.g., MOE, PyMOL) and AI-driven optimization algorithms. Hands-on experience with biophysical assays (e.g., SEC-MALS, ITC) and protein expression systems (CHO, HEK). Deep knowledge of antibody structure-function relationships and post-translational modification impacts. Experience managing teams running parallel protein engineering projects. Preferred: Familiarity with next-gen modalities (e.g., ADCs, multispecifics) or regulatory filings.
US$22000 - US$255000 per year
Boston
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Senior Computational Scientist (AI/ML)
Title: Senior Computational Scientist (AI/ML) Salary: $150,000-$345,000 Location: San Jose, CA Company Overview: EPM Scientific is currently partnered with an innovative biotech company that has developed a state-of-the-art AI/ML-driven drug discovery platform and continues to attract top talent from across the globe. With two late-stage clinical assets and strong financial backing, this company is well-positioned to advance R&D and cutting-edge technology development. Role Overview: We are seeking a highly motivated AI/ML Scientist to join our world-class research team and contribute to the next generation of computational drug discovery and protein engineering. In this role, you will apply advanced AI/ML techniques, including large language models, diffusion models, geometric deep learning, and computational protein design, to accelerate drug development and unlock new therapeutic possibilities. Key Responsibilities: Develop and apply machine learning models to solve complex challenges in computational biology, protein structure prediction, and drug discovery. Design, train, and optimize deep learning algorithms using PyTorch and other modern frameworks. Collaborate with interdisciplinary teams across AI, computational chemistry, and structural biology to integrate ML into drug discovery pipelines. Publish high-impact research in leading ML and computational biology conferences/journals (ICML, NeurIPS, ICLR, etc.). Stay ahead of cutting-edge advancements in AI/ML for biotech and contribute to the company's AI-first research strategy. Minimum Qualifications: PhD in Computer Science, Physics, Electrical/Computer Engineering, Bioinformatics, Computational Biology, or related fields. Strong research background with publications in top AI/ML conferences (ICML, NeurIPS, ICLR) or computational biology journals. Expertise in deep learning frameworks (PyTorch, TensorFlow, JAX) and programming in Python. Experience in one or more relevant areas: Large language models (LLMs) for molecular design. Diffusion models for molecular generation. Geometric deep learning for protein structure and conformation prediction. Natural language processing (NLP) for bioinformatics applications. Computational protein design and structure prediction. Ability to work collaboratively in a fast-paced, interdisciplinary research environment. Preferred Qualifications: Experience in drug discovery, molecular docking, or cheminformatics. Familiarity with biophysics, structural biology, or computational chemistry. Strong track record of contributions to open-source AI/ML research or applied biotech projects
US$150000 - US$345000 per year
San Jose
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R&D Senior Injection Molding Engineer
We have a current opportunity for a R&D Senior Injection Molding Engineer on a contract basis. The position will be based in the Netherlands. If you are interested then please get in touch. Key Responsibilities: Molding equipment build. Molding equipment release activities at the supplier (FOT- FAT). Molding equipment release on site (SAT). Insert mold testing, release and qualification. Injection molding process characterisation and qualification. Owner of all plastic cup injection molding related topics. Close coworking with the project team to understand the relation between plastic cups and final product performance. Delivering feedback/ input on plastic part design adjustments/ improvements based on performance results of the final product (intraocular lens). Execution of injection molding related process validation activities including analyze of product- and process performance. Understand and work according to quality assurance structure, approach and requirements. Requirements: Bachelor (or equal to) in plastic processing/ mechanical engineering At least 5 years of experience working in injection molding industries on engineering level High level of understanding injection molding tool design High level of understanding injection molding plastic processing Experience in scientific molding strategies Software usage such as 3D CAD (e.g. Solidworks), Simulation (e.g. Autocad Moldflow), Statistics (e.g. Minitab) Working under ISO 13485 standards GMP/ GDP Hands-on mentality Experience with documentation, report writing, instructions Work together in a multidisciplinary team over multiple sites Problem solving skills Process characterisation experience Continuous improvement
Negotiable
Netherlands
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