Analytical Development Director/Senior Director
Job Title: Director/Senior Director of Analytical Development Location: South San Francisco, CA Company: [Confidential Biotech Company] About the Company: This clinical-stage biotechnology company is dedicated to revolutionizing the treatment of heart disease. Their mission is to develop curative therapies that address the underlying causes of heart disease through innovative product platforms. With a robust pipeline, significant funding, and a leadership team composed of industry veterans, the company is well-positioned for success. Position Overview: The company is seeking a highly motivated and experienced Director or Senior Director of Analytical Development to join their team. This is a unique opportunity to lead analytical development efforts, particularly focusing on adeno-associated virus (AAV) vectors, and make a significant impact on their mission to transform heart disease treatment. Why Join the Company? Innovative Pipeline: The company boasts a strong pipeline of groundbreaking therapies targeting the root causes of heart disease. Their focus on AAV vectors and other advanced modalities positions them at the cutting edge of biotechnology. Strong Funding: Backed by substantial funding from top-tier investors, the company has the financial stability and resources to drive its ambitious research and development programs forward. Experienced Leadership: The leadership team is composed of industry veterans with a proven track record of success in biotechnology. Their expertise and vision are driving the company towards achieving its mission34. Collaborative Culture: The role involves close collaboration with cross-functional teams, including Manufacturing, Regulatory, and Quality, to support technology transfers and regulatory submissions. Professional Growth: The company offers opportunities for professional development and career advancement, valuing contributions and fostering innovation. Impactful Work: The candidate will contribute to life-changing therapies that have the potential to revolutionize heart disease treatment and improve patient outcomes. Key Responsibilities: Provide strategic, managerial, and technical leadership to the Analytical Development team. Design and execute phase-appropriate analytical strategies, including method development, qualification, and validation for AAV drug substances and drug products. Develop and set specifications for raw materials, intermediates, drug substances, excipients, and drug products. Establish and manage stability programs for non-GMP and cGMP drug substance and drug product batches. Oversee the review of raw data packages associated with method qualifications/validations, release testing, stability testing, and other characterization testing. Support regulatory submissions by drafting and reviewing analytical sections of INDs, IMPDs, and NDAs. Ensure compliance with ICH guidelines and maintain a strong quality system around drug substances and products. Qualifications: Ph.D. in Chemistry, Pharmaceutical Sciences, or a related discipline with 10+ years of industry experience, or BS/MS degree with 15+ years of industry experience. Extensive experience in analytical development of AAV vectors and solid oral dosage forms from preclinical to late-stage clinical development. Proven expertise in analytical techniques such as HPLC, GC, FTIR, UV-Vis, and other USP and EP methods. Strong understanding of cGMP requirements, ICH, FDA, USP, EP, and other pharmaceutical industry regulatory guidelines. Excellent leadership, communication, and project management skills. Ability to work in a fast-paced environment and manage multiple projects simultaneously.
Negotiable
San Francisco
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Associate Director/Director of Upstream Process Development
Director of Upstream Process Development Boston, MA Job Summary: The Director of Upstream Process Development will lead the design, optimization, and scale-up of upstream processes for biologics production, focusing on cell culture and fermentation technologies. The position will be pivotal in developing robust, scalable, and cost-efficient processes for the development of novel biologic therapeutic products. The ideal candidate will have extensive experience in bioreactor operations, cell line development, media optimization, and tech transfer. This is a hands-on leadership role with direct involvement in process development and close collaboration with downstream, analytical, and manufacturing teams. Key Responsibilities: Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement. Establish clear objectives, KPIs, and development plans for team members. Oversee the development and optimization of upstream processes, including cell culture, media development, bioreactor design, and process control strategies. Focus on high-yield, scalable processes using mammalian, microbial, or insect cell systems for biologic production. Implement robust experimental designs (DOE) to optimize parameters such as media composition, feed strategy, and culture conditions. Collaborate with cross-functional teams (e.g., downstream, analytical, QA/QC, regulatory, and clinical) to ensure seamless integration of upstream processes into the overall development pipeline. Lead efforts in scaling up upstream processes from bench-scale to pilot- and manufacturing-scale, ensuring process consistency and robustness. Coordinate and manage technology transfer to internal or external GMP manufacturing facilities (CMOs), ensuring the successful implementation of processes for clinical and commercial production. Troubleshoot and resolve scale-up challenges, ensuring alignment with quality and regulatory expectations. Lead or support the preparation of relevant sections for regulatory submissions (IND, BLA, etc.). Oversee the project lifecycle, from feasibility studies to full-scale production, ensuring timely delivery and alignment with project milestones. 20-25% travel in support of manufacturing activities at the CDMOs. Collaborate with cross-functional teams, including downstream development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and process success. Qualifications & Requirements: Master's or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field with 8 - 10 years of experience in upstream process development; with at least 5 years in a leadership role within the biopharmaceutical industry. Expertise in cell culture, fermentation, bioreactor operations (single-use and stainless steel), and process scale-up. Strong scientific background in cell line development, media optimization, and bioreactor operation. Hands-on experience with various cell culture platforms, such as CHO, HEK, microbial systems, and viral vector production. Proven track record in process characterization, validation, and regulatory submissions. Familiarity with automated process development tools and high-throughput screening technologies. Experience working with CDMOs and external manufacturing partners.
US$190000 - US$230000 per year
Boston
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Director, Drug Discovery (Novel Biologics)
Director, Drug Discovery - Biologics Location: Boston, MA Compensation: $220,000-$255,000 + Significant Bonus and Equity + Industry-Leading Benefits Package A global biopharma leader is seeking an experienced Director, Drug Discovery to take on a high-impact role in advancing biologics programs across multiple modalities, including cell therapies, bispecifics, immune cell engagers, and novel antibody-based therapeutics. This individual will play a critical role in shaping drug discovery strategy, leading functional screening and characterization efforts, and driving data-informed candidate selection for preclinical development. As a key scientific and strategic leader, this director will oversee a team of 7-10 scientists while also working cross-functionally as a program lead. They will be responsible for integrating discovery insights into broader pipeline decision-making, ensuring seamless progression from target identification through candidate nomination and IND-enabling studies. This is an opportunity for an established drug discovery leader to drive enterprise-level impact, working across multiple therapeutic areas including immuno-oncology, autoimmune, GI, inflammation, and neuroscience. The role offers broad exposure to cutting-edge biologics and the ability to influence discovery efforts across a rapidly expanding organization. Key Responsibilities: Lead discovery strategy for biologics programs, ensuring functional screening and characterization insights drive candidate selection and advancement. Serve as a program lead, spending approximately 30-40% of time working cross-functionally with research, development, and translational teams to align early discovery efforts with broader pipeline goals. Manage and develop a high-performing team of 7-10 scientists, fostering technical excellence, innovation, and career growth. Oversee the implementation of advanced discovery workflows, including high-throughput screening and emerging AI/ML-driven approaches. Partner with internal and external stakeholders to evaluate new technologies, therapeutic opportunities, and strategic collaborations that enhance biologics discovery efforts. Contribute to long-term organizational growth, playing a key role in the company's ongoing expansion and commitment to delivering multiple IND filings in the coming years. Requirements & Qualifications: Ph.D. in biology, immunology, pharmacology, cell therapy, or a related field with 12+ years of research experience. Industry experience in biologics drug discovery, with a track record of successfully advancing therapeutic candidates from early-stage discovery through IND. Strong expertise in biologics screening, functional characterization, and mechanistic assessment of novel drug candidates. Leadership experience managing scientific teams, with a demonstrated ability to mentor and develop both Ph.D. and non-Ph.D. researchers. Cross-functional collaboration skills, with experience working alongside research, preclinical, and translational teams to drive data-driven decision-making. Experience in biologics modalities such as cell therapies, bispecifics, immune cell engagers, or novel antibody-based platforms.
Negotiable
Boston
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Analytical Development, Quality Control Scientist
Are you looking for a partner to bring your pharmaceutical innovations to life? We are working with a leading Contract Development and Manufacturing Organization (CDMO) to make that happen for you. This company provides comprehensive services from initial drug development to commercial production, ensuring the products reach the market efficiently and effectively. This team of experts is dedicated to advancing the pharmaceutical projects with cutting-edge technology and innovative solutions. State-of-the-art manufacturing facilities to ensure the highest quality and compliance standards From concept to commercialization this company will provide tailored solutions to meet every unique need Position: Analytical Development and Quality Control Scientist Location: San Diego As an Analytical Development and Quality Control Scientist, you will play a crucial role in ensuring the quality and efficacy of the pharmaceutical products. Responsibilities: Create and optimize methods to support the selection and development of drug candidates. Transfer and validate analytical methods at third-party laboratories to ensure consistency and reliability. Oversee testing activities for drug products, active pharmaceutical ingredients (APIs), and raw materials at external contract research organizations (CROs). Conduct tests to support research and manufacturing, including release, stability, and characterization studies. Prepare, review, and evaluate scientific and technical protocols, reports, and quality control documents. Collaborate with QA, Regulatory, and Manufacturing departments to monitor and evaluate quality-related events such as out-of-specification results, deviations, and change controls. Requirements: Ph.D. in Analytical Chemistry, Biochemistry, or a related discipline. Minimum of 3 years of experience in pharmaceutical or biotech analytical development. Expertise in a variety of analytical techniques (e.g., HPLC, LC-MS, IR). Strong communication skills and fluency in English. Experience in a quality control environment and familiarity with regulatory guidelines. If you need any further assistance or have specific questions about the job, please feel free to ask!
Negotiable
Anaheim
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Senior Quality Engineer
Location: Midwest, USA (with Travel Requirements) EPM is working with an exceptional medical device company in the Midwest that is seeking experienced Senior Quality Engineers to join their team. This company specializes in ophthalmology, cardiovascular, and dental medical devices and is dedicated to developing high-quality, innovative healthcare solutions. Job Summary: We are looking for Senior Quality Engineers with expertise in sterilization processes and experience in ophthalmology, cardiovascular, or dental medical devices. This role will play a key part in ensuring compliance with global regulatory standards, leading quality initiatives, and optimizing manufacturing processes. Candidates must be comfortable with travel (60% - 70%) to suppliers, manufacturing sites, and regulatory bodies. Key Responsibilities: Maintain and enhance quality systems in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other relevant regulations. Lead sterilization validation efforts for processes such as EtO, Gamma, Steam, and E-Beam sterilization. Conduct supplier audits, internal audits, and risk assessments to ensure high product quality. Support CAPA investigations, root cause analysis, and process improvements. Collaborate with R&D, manufacturing, and regulatory teams to ensure compliance and product safety. Ensure adherence to GMP, GDP, and risk management (ISO 14971) practices. Travel up to 30-50% to suppliers, contract manufacturers, and regulatory bodies. Qualifications & Experience: Bachelor's or Master's degree in Engineering, Quality Assurance, or a related field. 5+ years of experience in the medical device industry, preferably with ophthalmology, cardiovascular, or dental products. Strong expertise in sterilization validation and process control. In-depth knowledge of ISO 13485, FDA regulations, MDR compliance, and process validation (IQ/OQ/PQ). Strong analytical and problem-solving skills, with experience in CAPA and risk management. Ability to travel up to 30-50% domestically and internationally. Why Join This Opportunity? Work with a leading Midwest-based medical device company at the forefront of innovation. Be part of a dynamic and collaborative team focused on patient safety and quality excellence. Competitive salary, benefits, and career growth opportunities. If you're a quality-driven professional with sterilization expertise and a passion for medical device compliance, apply today!
Negotiable
Ohio
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Cybersecurity expert
As part of a successful international team, you will be an important link between various R&D groups ensuring the cybersecurity of our products and processes. You will: Establish and maintain processes to ensure compliance with relevant standards (EN IEC 81001-5-1) and guidances (FDA, IMDRF, MDCG) on cybersecurity. Support the ISO 27001 certification. Provide cybersecurity training to internal staff and external partners. Stay up-to-date about emerging threats and best practices. Work closely with cross-functional teams, including R&D, quality, and regulatory affairs to ensure cybersecurity compliance in projects. Investigate and respond to security incidents. Conduct and maintain comprehensive threat modeling for web-based medical device applications. Identifying potential threats and collaborating with development teams to incorporate secure coding practices and mitigations. Monitor relevant databases for security events and communicate into the organization. Requirements Bachelor or Master in Information Science or Engineering with a strong SW background. Minimum of 2 years of experience in cybersecurity required, preferably in medical device cybersecurity. Relevant certifications (e.g. CISSP, CEH, CISM) are preferred. Strong knowledge of network security, vulnerability assessment, and cyber security risk management. Excellent problem-solving skills and attention to detail. Knowledge of software development lifecycle and methodologies. Knowledge of tools like Burp, Microsoft Threat Modeling Tool, and OWASP ZAP is a plus. Ability to work independently and as part of a team.
Negotiable
Germany
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Analytical Scientist
Analytical Scientist Florida Job Description: As an Analytical Scientist, you will play a crucial role in our research and development efforts. You will be responsible for developing and validating analytical methods from scratch, ensuring compliance with Good Manufacturing Practices (GMP), and utilizing advanced analytical techniques to support our projects. Key Responsibilities: Develop and validate analytical methods independently. Perform routine and non-routine analysis using techniques such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), and UV-Visible Spectroscopy (UV-Vis). Ensure all work complies with GMP regulations and standards. Troubleshoot and optimize analytical methods and instrumentation. Document and report analytical data accurately and promptly. Collaborate with cross-functional teams to support product development and quality control. Maintain and calibrate analytical instruments and equipment. Qualifications: Bachelor's, Master's, or Ph.D. in Chemistry, Analytical Chemistry, or a related field with minimum 2 years GMP industry experience. Proven experience in developing analytical methods from scratch. Strong knowledge of GMP regulations and practices. Proficiency in using HPLC, MS, and UV-Vis techniques. Excellent problem-solving skills and attention to detail. Strong communication and teamwork abilities. Ability to work independently and manage multiple projects simultaneously. Benefits: Competitive salary and benefits package. Opportunities for professional growth and development. Collaborative and inclusive work environment. Cutting-edge laboratory facilities and resources.
US$90000 - US$105000 per year
Fort Lauderdale
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Senior Director, Peptide Chemistry
Job Title: Senior Director, Peptide Chemistry Location: South San Francisco, CA Company Overview: Join the biotechnology arm of a leading global tech company, where we are driving innovation at the intersection of advanced science and cutting-edge technology. Our mission is to create first-in-class peptide therapeutics that fill the gap between small molecules and biologics ("Goldilocks" modality) to address complex diseases such as autoimmune and metabolic disorders. This is a high-priority role, offering the opportunity to shape strategy, lead collaborative teams, and make a significant impact on breakthrough treatments. Key Responsibilities: Innovative Leadership: Drive the discovery and optimization of cutting-edge peptide therapeutics, leveraging advanced design strategies to navigate the intricate balance between molecular structure and therapeutic efficacy. Lead multidisciplinary efforts to develop first-in-class therapies that bridge the gap between small molecules and biologics. Strategic Design and Development: Spearhead the ideation and implementation of innovative peptide-based approaches for addressing autoimmune and metabolic diseases. Utilize state-of-the-art peptide chemistry techniques to design molecules with tailored pharmacokinetics, target specificity, and functional activity. Cross-Functional Collaboration: Collaborate deeply with experts in biology, pharmacology, computational modeling, and translational sciences to ensure seamless integration of peptide candidates into the drug development pipeline. Champion a culture of scientific curiosity and excellence across teams. Technical Advancement: Incorporate cutting-edge technologies such as mRNA display and machine learning into the peptide drug discovery process, enhancing predictive modeling and candidate selection. Emphasize rational design principles to advance peptide candidates with superior therapeutic profiles. Pipeline Strategy: Play a pivotal role in defining program priorities and advancing key projects to preclinical nomination and beyond. Align efforts with broader company goals to deliver impactful therapies in high-need therapeutic areas. Peptide Chemistry Focus: Peptide chemistry sits at the forefront of modern drug discovery, offering unique therapeutic advantages by bridging the gap between small molecules and biologics. This role demands expertise in designing and optimizing peptides with enhanced stability, target affinity, and cell permeability. Candidates should demonstrate a deep understanding of structure-activity relationships (SAR), synthetic methodologies, and the development of multifunctional peptide-based modalities. Familiarity with integrating biologics and small molecules into peptide platforms is essential for creating therapies with transformative potential. Qualifications: Education: PhD in Organic Chemistry, Medicinal Chemistry, or a related discipline. Experience: 7-10 years of industry experience in peptide chemistry, with a track record of leading projects from discovery through IND filings and early clinical development. Expertise: Strong background in medicinal/synthetic chemistry, with a focus on peptides Experience in mRNA display (preferred) Familiaritry with integrating machine learning/AI for drug discovery (preferred). Familiarity with autoimmune and metabolic diseases; oncology peptide experience is acceptable. Proven ability to innovate in peptide drug design and development. Leadership Skills: Demonstrated ability to lead cross-functional teams and mentor junior scientists. Technical Knowledge: Expertise in integrating biologics and small molecules into peptide drug design.
ยฃ200000 - ยฃ300000 per year
Culver City
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Senior Scientist, Computational Chemistry/ML
Title: Senior Scientist Location: Boston, MA Company Summary: Currently partnered with a leading biotech incubator looking for a highly skilled computational scientist to develop and deploy cutting-edge molecular simulation technologies. This is a hands-on role requiring expertise in algorithm development, molecular dynamics, and machine learning applications. You will pioneer efforts to create scalable, production-level modeling pipelines that redefine how molecular interactions are understood and utilized in drug discovery. Responsibilities: Develop and implement advanced methods for molecular simulation, including AI-enhanced molecular dynamics and machine-learned force fields. Build robust, scalable cloud-based workflows for modeling biomolecular systems such as proteins, peptides, nucleic acids, and small molecules. **small molecules strongly preferred** Drive the integration of novel algorithms into existing computational pipelines to accelerate therapeutic development. Collaborate with interdisciplinary teams to address complex R&D challenges, ensuring computational tools are aligned with project needs. Validate, benchmark, and deploy innovative approaches for enhanced sampling, free energy calculations, and structure prediction. Qualifications: Ph.D. in Computational Chemistry, Biophysics, or related field with a focus on molecular simulation. Proven track record of developing and implementing novel algorithms for biomolecular simulation. Strong programming skills in languages like Python or C++, with experience in molecular simulation tools (e.g., OpenMM, GROMACS, AMBER, CHARMM) Familiarity with protein interactions such as: DiffDock, Autodock, Dock, Rosetta, RoseTTAFold-AllAtom Experience with machine learning frameworks (PyTorch, JAX) and cloud computing environments (AWS, Docker, Kubernetes). Expertise in AI-derived or polarizable force fields, enhanced sampling techniques, and free energy calculations. Demonstrated ability to scale computational workflows and optimize pipelines for large datasets.
US$200000 - US$250000 per year
Boston
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Senior Director, Peptide Chemistry
Job Title: Senior Director, Peptide Chemistry Location: South San Francisco, CA Company Overview: Join the biotechnology arm of a leading global tech company, where we are driving innovation at the intersection of advanced science and cutting-edge technology. Our mission is to create first-in-class peptide therapeutics that fill the gap between small molecules and biologics to address complex diseases such as autoimmune and metabolic disorders. Role Overview: We are seeking a dynamic and visionary Senior Director/Leader of Peptide Chemistry to spearhead our efforts in advancing novel peptide-based therapies. This individual will lead projects from ideation through preclinical nomination and into clinical development, contributing to the development of first-in-class therapeutics that redefine industry standards. This is a high-priority role, offering the opportunity to shape strategy, lead collaborative teams, and make a significant impact on breakthrough treatments. Key Responsibilities: Innovative Leadership: Drive the discovery and optimization of cutting-edge peptide therapeutics, leveraging advanced design strategies to navigate the intricate balance between molecular structure and therapeutic efficacy. Lead multidisciplinary efforts to develop first-in-class therapies that bridge the gap between small molecules and biologics. Strategic Design and Development: Spearhead the ideation and implementation of innovative peptide-based approaches for addressing autoimmune and metabolic diseases. Utilize state-of-the-art peptide chemistry techniques to design molecules with tailored pharmacokinetics, target specificity, and functional activity. Cross-Functional Collaboration: Collaborate deeply with experts in biology, pharmacology, computational modeling, and translational sciences to ensure seamless integration of peptide candidates into the drug development pipeline. Champion a culture of scientific curiosity and excellence across teams. Technical Advancement: Incorporate cutting-edge technologies such as mRNA display and machine learning into the peptide drug discovery process, enhancing predictive modeling and candidate selection. Emphasize rational design principles to advance peptide candidates with superior therapeutic profiles. Peptide Chemistry Focus: Peptide chemistry sits at the forefront of modern drug discovery, offering unique therapeutic advantages by bridging the gap between small molecules and biologics. This role demands expertise in designing and optimizing peptides with enhanced stability, target affinity, and cell permeability. Ideal candidates should demonstrate a deep understanding of structure-activity relationships (SAR), synthetic methodologies, and the development of multifunctional peptide-based modalities. Familiarity with integrating biologics and small molecules into peptide platforms is essential for creating therapies with transformative potential. Qualifications: Education: PhD in Organic Chemistry, Medicinal Chemistry, or a related discipline. Experience: 7-10 years of industry experience in peptide chemistry, with a track record of leading projects from discovery through IND filings and early clinical development. Expertise: Strong background in medicinal/synthetic chemistry, with a focus on peptides/macrocyclic compounds. Experience in mRNA display (preferred) Understanding of the integration of machine learning/AI for drug discovery (preferred). Familiarity with autoimmune and metabolic diseases Strong preference for expertise in advancing projects through Preclinical Candidate Nominations and achieving clinical readiness milestones Proven ability to innovate in peptide drug design and development. Expertise in integrating biologics and small molecules into peptide drug design.
US$200000 - US$300000 per year
South San Francisco
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