Technical Project Manager
We have a current opportunity for a Technical Project Manager on a contract basis. If you are interested or know any friends or family that are then please send me your CV so we can discuss further. 12 months Full time - 40 hours per week 3 days on site Key Areas of Responsibility Delivery of the manufacturing element of new product programs, with specific focus on scope setting, project planning and management, product quality, budget management, product supply management and DFM (Design for Manufacture). Provides strong, capable leadership to the project team encompassing of key professionals from Quality, Sterilisation, Production, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Process Engineering, Facilities & EH&S to ensure new product launch deliverables are achieved. Assumes overall responsibility for assigned teams and operational deliverables. Collaborates closely with leadership at the manufacturing site during the design development phase to ensure that all new manufacturing processes are introduced into production compliantly, on time, within budget, are operationally successful, and in alignment with the broader plant manufacturing strategy. Ensures all required quality management system deliverables are met by the team to effectively transfer the product into commercialisation from the design development phase. Drives capital acquisition strategy through determining total capital expenditure and operational expense, acquiring internal approvals, supporting contract negotiations and ensuring timely installation, qualification and validation efforts. Develops a comprehensive communication plan and strategy to convey project status updates to stakeholders at both Commercial and Operational business forums. Liaises with Regulatory Affairs to ensure the project strategy is aligned with the required regulatory pathway and appropriate regulations are met.
Negotiable
Cork
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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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Research Scientist
A Swiss life science start up is currently in its early development stages in Zurich. The company's research focuses on creating innovative, patient-specific, and clinically relevant drug sensitivity testing technologies. The main goal of these technologies is to improve disease management and help healthcare professionals optimize patient treatment outcomes. Additionally, the company aims to collaborate with pharmaceutical research partners. A crucial aspect of the technology involves developing clinical assays and processes for automated, patient-specific drug testing in partnership with the clinical collaborators. To bolster the research team, we are looking for a highly motivated, adaptable individual with an entrepreneurial mindset. Research scientist (80-100 %) The ideal candidate S. or M.Sc. with a sound background in cell biology and cell culture technology 2 years professional experience in industry or academic institutions Experiences in managing scientific projects and/or collaborations Cell culture expertise Hands-on experience in 3D tumor models is highly preferred Experience with lab automation is an advantage Team player and multitasker Your responsibilities Plan, coordinate, and carry out internal and external R&D projects Develop and manage a detailed project and work plan Coach and supervise laboratory work and compliance with standards Support product development Manage contracts with vendors and suppliers by assigning tasks and communicating expected deliverables Prepare reports and present experimental results at group and project meetings Good command of English in communication and writing Travel to other business locations within the EU Hands-on laboratory work with cytostatic chemicals will be required Occasional weekend work may be required
Negotiable
Zurich
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Process Development Engineer
Process Development Engineer (m/f(d) Role -Optimize and validate packaging processes (vision and serialization systems). -Conduct feasibility studies and manage capital projects for new equipment. -Ensure regulatory compliance and communicate requirements effectively. -Perform root cause analysis and manage changes via Trackwise. -Collaborate with cross-functional teams to troubleshoot and improve operations. -Investigate quality events, document deviations, and ensure accurate records. -Foster a culture of fairness, safety, and continuous improvement. -Train team members and uphold company standards. Qualifications -Bachelor's degree in engineering or related field. -3+ years in Pharma Manufacturing with expertise in Secondary Packaging systems; knowledge of Primary Packaging, Vision, and Serialization systems preferred. -Strong project management, documentation, and multitasking skills.
Negotiable
Dublin
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Director of Laboratory Services
We have a current opportunity for a Director of Laboratory Services on a permanent basis. The position will be based in San Antonio. For further information about this position please apply. Technical knowledge - the candidate will be required to articulate testing platform acumen. This should include comprehensive understanding of serology, immunoassay, and testing for bloodborne infections like hepatitis B, hepatitis C, and HIV. Experience in Managing or Directing a high volume, high speed, multiple shift production lab - the candidate will have demonstrated capabilities in automation as it relates to Donor Screening tests (e.g., NAT, VMT). The position is responsible for operating within budgets, meeting and exceeding testing turnaround times, employee and lab performance, and development of staff. Regulatory Inspection - the candidate will have participated (preferably led) in multiple inspections to include CLIA, CAP, FDA, etcโฆ These inspections would be applicable to registration, accreditation or licensure as opposed to 'mock'. This position is responsible for regulatory compliance including FDA, CLIA, CAP, GMP, AABB, ISO, EU, and others. Director presence - the candidate will have successfully presented as a professional, credible, and influential leader, effectively communicating the company's broader vision internally and externally.
US$125000 - US$160000 per year
San Antonio
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Executive Director, Cell Therapy Pipeline Strategy
Job Title: Executive Director, Cell Therapy Pipeline Strategy Role Overview The Executive Director, Cell Therapy Pipeline Strategy will lead project development teams to advance cell therapies and related modalities through a robust pipeline. This role sets the strategic direction for cross-functional teams, integrating non-clinical, clinical, regulatory, CMC, and commercial efforts from development to launch. It requires exceptional leadership in product development and team oversight to deliver projects on time in a science-driven, collaborative environment, acting as the primary point of accountability for pipeline success. Key Responsibilities Establish and lead cross-functional project teams, defining goals and driving collaboration. Create and implement integrated development strategies with clear timelines, risks, and decision points. Track progress, resolve dependencies, and ensure high-quality project execution. Navigate teams through governance reviews and adapt strategies to shifting priorities. Mentor junior project leaders and cultivate talent for early-stage programs. Monitor competitive landscapes and refine approaches for best-in-class outcomes. Partner with project management to enhance processes and manage risks with mitigation plans. Serve as the central point of accountability for project outcomes across the organization. Requirements Advanced degree (MD, PhD, PharmD) or equivalent with 15+ years of biotech/pharma industry experience. Proven leadership in project management and team supervision, specializing in cell therapy pipelines. Extensive expertise in autologous/allogeneic cell therapy, viral vectors, and CMC processes. In-depth knowledge of regulatory frameworks and clinical development for cell therapies. Strong track record of leading cross-functional teams, prioritizing tasks, and tackling complex technical and strategic issues. Advanced analytical skills for data-driven decisions and risk evaluation. Superior communication and emotional intelligence to unify diverse stakeholders. Innovative problem-solving and strategic vision with composure under pressure.
Up to US$325000 per year
New Jersey
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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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