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- San Francisco Bay Area, CA
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Associate Director / Director, Process Development – San Francisco Bay Area Responsibilities: Process Development of small molecule oncology drug candidates from research to validationSubject Matter Expert for process chemistry. Attend CMC meetings, provide status assessments and technical expertiseExperienced organic chemistry skills and leadership abilities to oversee outsourced projects at CRO/CMOCreate technology transfer, scale up and late stage supply chain strategy. Evaluate process....

- Boston, MA
new job!

My client seeks a Computational Chemist for an applications role. The ideal candidate will support small molecule drug discovery efforts from lead identification to candidate selection. The ideal candidate will take on the following tasks: Liaise with medicinal chemists and project teams to address challenging drug discovery problems with computational chemistry expertise.Leverage proprietary data, design applications, and computional infrastructure in conjunction with commercial tools and....

- San Diego, CA
new job!

Computational Chemist My client offers a great opportunity to join a growing, vibrant firm and make an impact on drug discovery and development. The ideal candidate will focus on applying structure and ligand based drug design methods to design molecules with superior pharmacological properties. The ideal candidate will lead and support project teams, and take on the following tasks:Support medicinal chemists and project teams by applying a wide variety of methods to improve potency,....

- San Diego, CA

Our client - a major Pharmaceutical company in SoCal - is looking for Analytical Chemists. These Chemists will work within the company's Analytical R&D department. Responsibilities will include:Method Development / Method ValidationDevelopment of stability studies Performing literature searches Documenting/Recording all experimental activities in laboratory notebooksThe Qualified Candidate will have analytical methods development experience in a pharmaceutical environment. (4-10+....


SR. GVP AUDITOR - San Francisco Bay Area RESPONSIBILITIESIndependently evaluate compliance of logistics and business partners with PV regulations: FDA, EMA, ANVISA and other relevant regulations under International Competent Authorities Plan, conduct domestic and international GVP audits to assess compliance to local and global government regulationsMust be able to work within a global team setting as well as an individual contributorPerform systems audits and due diligence reviews, identify....


Director of Quality Assurance My client is focused on cell therapy products, and they actively seek a QA Director. The ideal candidate will take on the following tasks:Establish, develop and manage the quality management system for the firm.Build the quality department infrastructure to assure compliance to company, industry standards and the applicable regulatory requirements.Interface with external personnel (vendors, partners and regulatory bodies) and internal personnel (management and....


Sr Automation Engineer Job Description: As a member of the Engineering and Facilities Reliability Automation team, the successful candidate will be required to support complex and challenging system automation initiatives that require solid understanding of analytical problem solving techniques, project management, lifecycle management and Operational Excellence. This position requires an extensive understanding and background in programming, design, installation and lifecycle management of....

- Western, MI

Company:Strong collegial group of people with a very strong team-minded cultureFast-paced work environment on highly technical projectsVery community-minded with a strong sense of giving back to the community with time and talents for charitable organizationsVery strong work-hard, play-hard mentality with fun events outside the officeCompany has grown nationally and this office is slated for growth as wellPrivately-held- you won't be a number hereNationally recognized for innovative,....

- Bridgewater, NJ

My client is actively recruiting for a Director of Clinical Operations – this is a high profile position where the Director will be responsible for managing the clinical trial strategy in collaboration with the Medical Affairs Team, regulatory strategy and execution, publications strategy and plan. The ideal candidate will have clinical operations experience in pharma or biotech industries (in the oncology space.) The ideal candidate will take on the following tasks: --oversee clinical trials....

- San Francisco, CA

Outstanding opportunity for a Director of Quality for Clinical GCP. My client is seeking a talented Clinical Quality professional who has significant experience in ensuring that Clinical Trials are in compliance with Good Clinical Practice (GCP). Reporting in to the VP, this individual will be responsible for ensuring quality systems, procedures and documentation are in compliance with applicable US and international standards and regulations. While this is initially an individual contributor....


My biotech client seeks a VP, Regenerative Medicine to take on the following tasks: Direct operations including administration, workflow organization, and managing lab personnel and performance (including academic collaborations and CROs.)Guide the method development of FIH combination product.Drive the strategy for translational research development and establish collaborations.Support the development of biologics programs.Serve as an integral member of the discovery and development teams and


QUALITY ASSURANCE (QA) MANAGER - (SECOND SHIFT) IllinoisManage QA program and staffOversee prevention and take action to resolve flaws in products.Oversee staff requirements of the QA Ops departmentReview and Release production batch records / productsKeep Quality Metrics for batch record reviewDeliver data from batch record review for analysisRespond in a timely manner to audit observations and deficienciesManage QA auditors during auditsUpdate and follow QA Operations training strategy and....


Senior Manager / Associate Director, Regulatory Affairs (Global / Oncology) – San Francisco Bay AreaCreate content and timelines of regulatory submissionsIdentify regulatory issues and provide solutionsLead content and publishing of documents for original INDs & NDAsLead efforts to produce an IND each yeaLead preparations for Regulatory Agency meetingsLead efforts to produce regulatory documentsCommunicate with global regulatory organizations to prepare applicationsAssure compliance with....


Senior Clinical Data Manager, CDM - San Francisco Bay Area Responsibilities: Oversee clinical development activities and strategy executionsing the highest standards, manage the CD plan and the collection and interpretation of clinical dataContribute to the data preparation for reporting study results, regulatory submissions, and publicationsUse EDC Systems for data managementApprise management and project teams of clinical data activitiesContribute to the development and implementation of....


Packaging/Facilities Maintenance Supervisor, 2nd Shift Somerset, New Jersey Duties Overseeing maintenance and packaging mechanics staff functions and delegating tasks to staff. 24 hour “on call” status for equipment emergency repairs. Oversees preventative maintenance on all production and facility equipment Works cross functionally with all departments to increase the capacity of the manufacturing group by enhancing the equipment reliability. Requests, schedules, and oversees the activities....

- Los Angeles, CA

Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.Implements and maintains programs and processes to ensure high quality products and compliance


- Minimum of 7 years laboratory experience or equivalent - Experience working in pharma in a GMP lab environment - Management experience with multiple direct reports - Experience in talent training and development - Proven ability to work as part of a collaborative team, solving problems while improving the organization and its capabilities - Excellent interpersonal and communication skills are required - Will handle hazardous materials - Must be able to work while wearing personal protective....


BS Engineering w/5 plus years experience in biotech/pharmaceutical engineering preferredDemonstrated ability to perform hands-on, detailed work, in a fast-paced manufacturing environmentExperience working on the floor in a manufacturing process environment requiredProficient in the design, installation and implementation electro-mechanical control systemsAbility to troubleshoot electrical systems and automated equipment in a GMP environmentKnowledge of practices applied to the preparation of....


Neuroscience is seeking an experienced scientist to join the Neurodegeneration team to facilitate its mission of discovering novel medicines for the treatment of Alzheimer’s disease, Parkinson’s disease, and other related neurodegenerative conditions. You will lead a laboratory focused on developing small and large molecule therapeutics in close collaboration with other Neurodegeneration laboratories and chemistry and biotherapeutic engineering divisions. An important focus will be the....


Minimum Requirements: B.S. Chemical Engineer, Mechanical Engineer, Chemistry with a minimum 8+ years of experience out of chemicals, pharmaceuticals, biotech, foods, or something very closely related. Candidates must have two years’ previous supervision experience, but they do not need to have prior plant management experience. They should have supervised at least 15 operators. Pluses would be: previous budget responsibility, previous maintenance experience or experience overseeing....

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