R&D Manager (CMC Lead)
R&D Manager/ CMC Lead Location: Pennsylvania Region Salary: $165,000-185,000 + Bonus + Benefits A CDMO in the greater Philadelphia area is looking to bring on an R&D Manager/ CMC Lead to assist in leading their R&D Small molecule team. This opportunity will provide the chance to wear multiple hats within the R&D department while focusing on Project management and Formulation Development. The ideal individual will have a strong Formulation Development background with a primary focus on small molecules and exposure to Operations/ Project Management throughout their career development. As an R&D Manager, they will be provided the chance to grow within the CMC space while serving as an individual contributor to the team. Responsibilities: Primary focus on Formulation Development and Project management. Leading, developing, training and mentoring the R&D team while having them collaborate cross functionally. Focusing on a small molecule background with a variety of dosage forms specific to transdermal and oral think film applications. Overseeing R&D departments on time deliverables and project deadlines. Leading business in formulation while applying intellectual property strategy. Establish innovative projects pertaining to the discovery of new technologies. Qualifications: a PhD in Pharmaceutical Sciences or related field with 5+ years of technical experience within the R&D industry. Background or exposure to Project management and Operations in prior roles. A strong Formulation Development background with a primary focus on small molecules. Experience in intellectual property is a MUST. An understanding of various analytical techniques such as HPLC and UPLC. Proficient in communication, interpersonal, and team collaboration skills skills. Strong background in transdermal/ oral thin film applications is highly valued.
Negotiable
Pennsylvania
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CMC Lead (Director/Sr Director/VP)
A leading organization in the field of cellular therapy is seeking a skilled individual to join our dynamic team as a CMC Lead. This pivotal role involves supporting U.S. regulatory activities pertaining to our cutting-edge cellular therapy programs, particularly focusing on spearheading the CMC product strategy for our innovative CAR T pipeline. Responsibilities: Lead GMP-compliant manufacturing operations, overseeing technology transfer, process development, optimization, and GMP manufacturing. Ensure the development and optimization of robust and scalable CAR T manufacturing processes, emphasizing yield, purity, and product consistency. Maintain compliance with relevant regulatory guidelines, including those set forth by the FDA and other global health authorities. Collaborate effectively with cross-functional teams to align CMC activities with overall company objectives. Provide expertise in CMC for global development and registration programs, including INDs, CTAs, BLAs, and MAAs. Act as the primary regulatory representative for assigned projects, both internally and in meetings with regulatory agencies. Offer regulatory support for pertinent quality systems, such as change control, discrepancy management, and inspection management. Manage contract staff and vendors as necessary to support regulatory activities. Drive Process Development group goals and assist in managing project plans, timelines, and budgets. Establish the strategy and infrastructure for developing novel production processes for candidate engineered T cell therapeutics. 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$200000 - US$280000 per year + Medical, Dental, Vision, 401K
United States of America
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Director of Software
Director Of Software Location: Zurich, Switzerland Job type: Full time / permanent Lead our R&D team in shaping the future of healthcare. Drive innovation in cutting-edge diagnostics, foster collaboration, and oversee end-to-end product development. Your strategic leadership is crucial to our industry leadership and pushing the boundaries of medical technology. Responsibilities As VP of Software Engineering, you'll be responsible for: Leadership & Strategy: Guide and grow a talented software engineering team. Develop and execute a strategic vision for software development that aligns with our business goals. Innovation & Development: Oversee the development of our platforms, ensuring seamless integration of hardware, software, and AI components. Cross-Functional Collaboration: Work closely with product, design, and other departments to deliver a premium end result. Quality & Standards Compliance: Uphold the highest standards of software quality and compliance, particularly in the context of MedTech regulatory requirements. Talent Management & Development: Attract, retain, and develop top talent, fostering an inclusive and collaborative team culture. Qualifications And Experience Proven experience in a senior software engineering leadership role, preferably within a company that has a hardware component. Worked and led in a fast-paced software environment. Has rolled out software on a large scale. Strong technical background in software development, ML/AI, and system architecture. Excellent leadership skills with a track record of building and mentoring high-performing teams. Experience in a start-up or fast-paced growth environment is highly desirable. Strong problem-solving abilities and a forward-thinking mindset. Excellent communication and collaboration skills. Salary DOE If you are interested in this role, please contact Morgan Fannin. E-mail:
Negotiable
Zurich
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R&D Staff Engineer
The role of Senior Staff Engineer takes on a hands-on, customer facing, technical leadership role on a cross functional project core team guiding the design, development, verification and validation of on-body combination products in support, this role will give the opportunity to develop user-centric on-body drug delivery solutions designed to drive patient empowerment, independence, compliance, and improved health outcomes. Responsibilities: * Be part of the team representing the organisation as one of the prime technical contacts to a pharma partner on a B2B product development project. * Deliver on new and exciting advanced drug delivery solutions as a technical leader on a cross-functional project team through all phases of the project life-cycle, from concept through launch. * Translate business requirements into a robust, scalable technical design. * Pursue complex problems by applying sound engineering principles, utilising experimental, computational and analytic methods to a range of technical product development challenges over a range of products from simple disposable components to complex electromechanical and "smart" device assemblies. * Work closely with both functional teams and project managers to identify and mitigate technical issues to reduce programmatic risks. * Improve product development cycles and quality via the application of DFSS and Lean Product Development Tools * Develop and guide technical design/methodologies to achieve product goals, * Work within a team of R&D associates, applying best design practices, analysis, simulation and verification of subsystems and systems. Technical Leader capable of: * Representing R&D within a team of QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members by facilitating effective communication and engagement. * Mentor and motivate team members and junior associates while coaching them through activities such as bench studies, tolerance stack up analysis, FMEAs, design verification, validation, vendor interactions, materials specifications and component specifications. * Demonstrate excellent interpersonal communication skills, which enable you to gain client trust and mentor junior engineers. * Be an agile learner, tolerant of risk, and biased towards action * Effectively and clearly communicate concepts, ideas and knowledge to other individuals, teams and customers * Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety laws, policies and procedures. Requirements: * BSc Engineering or technical degree. * 5-8 years related work experience in medical device development with an emphasis on wearable infusion pumps, large volume injection devices, or the like. * Must have strong verbal and written communication skills, including customer, and/or varying internal/external stakeholder interaction experience * Deep experience in the selection and/or design and commercialisation of parenteral drug delivery devices in the Biotech industry. * Proven track record of executing complex system designs incorporating mechanical subsystems, preferably in the medical device field * Ability to lead multi-discipline engineering project teams * Proficiency with modern CAD, CAE and other design / simulation tool
Negotiable
Dublin
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EMC Test Engineer
Join Our Clients Team as an EMC Test Engineer in Baden-Wurttemberg, Germany Introductory paragraph: Our client is seeking a skilled and experienced EMC Test Engineer to join their team located in the beautiful city of Ichtershausen, Germany. As part of this role you will be responsible for ensuring that all products developed by our clients meet relevant regulatory requirements with regards to Electromagnetic Compatibility (EMC) testing. Qualifications: - Bachelor's degree or higher qualification in Electrical Engineering - Previous experience working within Notified Body environment - Experience conducting EMC testing on Medical Devices & Automotive industry Skills: The ideal candidate should possess the following skills; 1. Strong knowledge of Regulatory Compliance Standards - You must have comprehensive understanding and ability to interpret complex regulations related to European Union standards regarding medical devices. 2. Ability To Conduct Testing - The successful applicant needs experience performing tests such as radiated emission/susceptibility test set-up; conducted emissions/susceptibility test setup along with general laboratory equipment operation including signal generators, spectrum analyse etc.. 3.Excellent Analytical Skills -You need strong analytical abilities which enable you work through technical problems effectively. 4.Good Communication Abilities- Effective communication between colleagues & customers are essential so being able communicate ideas clearly both verbally and written form would be beneficial. Responsibilities include but not limited; * Development ,implementation various kinds electrical safety measure plans based upon customer specifications, * Investigate product issues pertaining electromagnetic interference/compatibility , * Providing expert advice concerning any matter relating quality management system procedures Salary : ยฃ65,000 If your qualifications match those listed above we want you! Apply today for immediate consideration .
ยฃ55000 - ยฃ70000 per annum
Baden-Wรผrttemberg
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Quality Director
Job Title: Quality Director Location: Taiwan (Relocation Available) Company Overview: We are a leading pharmaceutical company dedicated to improving the health and well-being of patients worldwide. With a commitment to excellence and innovation, we strive to deliver high-quality pharmaceutical products to meet the evolving needs of our customers and patients. Position Overview: We are seeking a highly skilled and experienced Quality Director to join our manufacturing site in Taiwan. The Quality Director will play a key role in ensuring that our manufacturing operations meet the highest quality standards and regulatory requirements. This individual will lead a team of quality professionals and work closely with cross-functional teams to drive continuous improvement initiatives and uphold our commitment to quality excellence. Key Responsibilities: Develop and implement quality strategies, policies, and procedures to ensure compliance with regulatory requirements and industry standards. Lead and mentor a team of quality professionals, providing guidance and support to ensure effective execution of quality initiatives. Oversee the quality management system, including document control, training, deviation management, change control, and CAPA processes. Conduct risk assessments and develop risk mitigation strategies to prevent quality issues and ensure product safety and efficacy. Collaborate with cross-functional teams, including Manufacturing, R&D, Regulatory Affairs, and Supply Chain, to drive quality improvement initiatives and resolve quality-related issues. Ensure timely and accurate completion of quality-related documentation, including batch records, validation protocols, and regulatory submissions. Lead internal and external quality audits and inspections, ensuring compliance with regulatory requirements and driving corrective actions as needed. Stay abreast of industry trends and regulatory developments, proactively identifying opportunities for process improvement and risk mitigation. Qualifications: Bachelor's degree in Pharmacy, Chemistry, Biochemistry, or related field; advanced degree preferred. Minimum of 8 years of experience in quality assurance or quality control within the pharmaceutical industry, with at least 3 years in a leadership role. In-depth knowledge of cGMP regulations, ICH guidelines, and other relevant regulatory requirements. Strong leadership and team-building skills, with a proven track record of effectively leading and developing high-performing teams. Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and influence stakeholders at all levels of the organization. Demonstrated ability to drive continuous improvement and implement best practices to enhance quality systems and processes. Experience with regulatory inspections and audits, including FDA, EMA, and TFDA inspections, is highly desirable. Fluency in English and Mandarin Chinese is required. Apply now with your CV and relevant candidates will recieve a call back from one of our consultats to discuss further.
Negotiable
Taiwan
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Associate Principal Scientist
Our client, a global biotech firm seeking an experienced and motivated individual to join their team as an Associate Principal Scientist. This position offers the opportunity to work on cutting-edge research projects that have significant potential impact on drug discovery. Responsibilities: Lead Discovery Biology efforts for advancing drug targets in Inflammation and Immunology Collaborate across teams to identify and validate therapeutic targets using various models. Contribute to advancing drug discovery programs from lead identification to preclinical candidate selection. Design experimental plans, analyze data, and stay updated on scientific advancements to inform project strategy, while mentoring team members. Qualifications: A PhD degree in Immunology or Life science related discipline At least 7 years' of research experience in the lab At least 3 years of industry experience Proven track record of successful project delivery demonstrating creativity, innovation & teamwork Familiar with drug discovery principles Strong team player Strong communication skills If you are interested in this role, please apply with your CV attached.
Negotiable
Singapore
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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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