Specialist, Safety N02   Qualifications: • Bachelor’s degree, preferably in an applicable scientific discipline (such as Environmental Engineering or Medical Technology), or equivalent knowledge and experience. • Advanced Certification (such as CSP, ASP, or CIH) or advanced coursework/master’s degree in Work Environment or similar preferred. • Working knowledge of federal, state, and...

The Senior Director, Clinical Quality Assurance is responsible for establishing and implementing the strategy for the Clinical Quality Assurance (QA) function. This role is responsible for leading Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP), and Good Pharmacovigilance Practice (GVP) QA activities including the development and execution of program or study level...

Title: Project Engineer Onsite / Hybrid situation working out of either Worcester, MA or Cranbury, NJ. Reports to PM, will also work directly with a few current employees. Must haves for the role - Years of total industry experience: Approx. 10 years of field experience in Pharma - Demonstrated capability to support large Capex projects. - This is a Mechanical or Electrical Engineer...

Candidate Profile The successful candidate will have a strong scientific background and laboratory skills in immunology, regulatory T cell biology, and/or autoimmunity with experience developing novel therapeutic approaches using in vitro and in vivo models. Preferred experience includes knowledge of regulatory T cell biology, CRO management and designing focused preclinical studies that assess...

The primary responsibility of the Medical Science Liaison (MSL) is to act as a liaison with nationwide and regional key opinion leaders (KOLs) to align interests, discuss research and medical information, and to facilitate both clinical trial efforts of the company and Investigator-sponsored studies in relation to Somatuline in the treatment of Gastro-entero-pancreatic neuroendocrine tumors (GEP...

The primary responsibility of the Medical Science Liaison (MSL) is to act as a liaison with nationwide and regional key opinion leaders (KOLs) to align interests, discuss research and medical information, and to facilitate both clinical trial efforts of the company and Investigator-sponsored studies in relation to Somatuline in the treatment of Gastro-entero-pancreatic neuroendocrine tumors (GEP...

Manager, Quality Engineering   Overview As Manager, Quality Engineering he/she will perform tasks that will uphold and improve the product quality of the medical devices manufactured and meet regulatory requirements to stay in compliance.   Responsibilities • Formulates and maintains quality objectives (goals) complementary to corporate policies and goals of building high quality medical...

Assists the local PV Manager (LPVM) for Global Patient Safety (GPS) · Support and attend affiliate/GPS meetings to ensure awareness of any changes in global and/or regional requirements of the PV system · Provides Pharmacovigilance expertise into all areas of the business as required. · Ensure a comprehensive local PV system · Ensure all PV activities are delivered in line with local...

POSITION OVERVIEW:  Senior Supplier Quality Engineer Precision Life Sciences Accountable for the development, execution and delivery of quality strategies for the Management of Suppliers and received goods, services and materials in accordance with cGMP. Partner with Operations, Product Development, Manufacturing Engineering, and Regulatory to assure all quality deliverables are met within cost,...

This role will Act as a statistical programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. What You’ll Do • Develop, implement, and maintain programs for the activities such as data review and safety signaling analysis on ongoing basis. •...

Remote - in Phoenix Arizona   Installs, calibrates, repairs and inspects imaging devices, robots and computers and solves moderately complex problems in the field. Performs repairs up to and including the diagnosis and repair of difficult technical instrument and software problems. Participates in product improvement discussions, provides inputs to design engineering. Provides information and...

Responsibilities: • Providing operational expertise and strategic input to the development of Clinical Development Plans (CDP) supporting the overall clinical strategy for assigned clinical program(s); may lead some trial management activities within assigned program as well. • Providing program-level sponsor oversight of CRO and 3rd party vendors to ensure the effective execution of the...

ROLE RESPONSIBILITIES · Lead startup and checkout of electrical systems · MUST HAVE “hands on” electrical energization experience. · Responsible for safe startup of systems. Perform safety risk assessments to identify and mitigate safety hazards. • Ability to effectively communicate, interact and collaborate with team members and external stakeholders is essential. • Planning of daily...

In Vivo Scientist (Autoimmune/Oncology)   Job Overview Qualified candidates will possess a Ph.D. degree with 1-8 years working experience in autoimmune diseases, immunology and/or immuno-oncology research. Additional experience in in vivo pharmacology, flow cytometry, cell culture experience is also highly desired. The individual will work hands on at the research bench with oncology mouse...

  This job description applies to the capital project to create a new aseptic filling facility on the site in Kalamazoo, MI. This role will report to the startup manager.   ROLE RESPONSIBILITIES   · Spend 90% of time in the field, observing, mentoring, and coaching the utility and equipment startup, commissioning, and verification teams. · MUST HAVE “hands on” experience with utility...

The Manager, In Vivo Scientific Operations, in accordance with Good Laboratory Practice oversees a core scientific area within In Vivo Services and is responsible for developing an effective and efficient team by driving cross-functional coordination and communication, developing risk identification/mitigation strategies, ensuring processes are optimized, and projects are successfully executed...

ROLE RESPONSIBILITIES · Lead startup and commissioning of HVAC systems · MUST HAVE “hands on” utility energization and equipment commissioning experience. · Responsible for safe startup of systems. Perform safety risk assessments to identify and mitigate safety hazards. • Ability to effectively communicate, interact and collaborate with team members and external stakeholders is essential....

Installs, calibrates, repairs and inspects imaging devices, robots and computers and solves moderately complex problems in the field. Performs repairs up to and including the diagnosis and repair of difficult technical instrument and software problems. Participates in product improvement discussions, provides inputs to design engineering. Provides information and develops procedures. In addition...

This job description applies to the capital project to create a new aseptic filling facility in Kalamazoo, MI.   ROLE RESPONSIBILITIES · Lead startup and commissioning of plant utility systems. · MUST HAVE “hands on” utility energization experience. · Responsible for safe startup of systems. Perform safety risk assessments to identify and mitigate safety hazards. • Ability to effective...

ROLE RESPONSIBILITIES · Lead startup and commissioning of GMP utility systems. · MUST HAVE “hands on” utility energization experience. · Responsible for safe startup of systems. Perform safety risk assessments to identify and mitigate safety hazards. • Ability to effectively communicate, interact and collaborate with team members and external stakeholders is essential. • Planning of...

Engineer, Product Life Cycle   Overview Serve as the hands-on Engineer responsible for development or revision of testing protocols and reports aimed at continued regulatory compliance with existing and revised industry standards related to Class I, II and III medical devices.   Responsibilities Continuously engage with Regulatory affairs and Quality affairs teams to ensure that all...

Sr. Specialist, Quality Assurance - Internal Audit   Overview As Sr. Specialist, Quality Assurance, he/she will perform task that will uphold and improve the product quality of medical devices manufactured and meet regulatory requirement to stay in compliance.   Responsibilities • Executes day to day activities based on quality objectives (goals) complementary to corporate policies and...

Senior Scientist, Downstream Process Development Looking for a scientifically innovative individual and respected people manager to join the Process and Product Development team as SeniorScientist, Downstream Development. In this role, you will develop and implement viral vector purification strategy and processes for the production of novel gene therapy technology platform. The Senior Scientist...

This exciting opportunity is for an experienced Design Manager to be a part our Coppell TX Engineering Team. The Coppell site expansion plans span over the next years and include major new facilities including:-   1. A second manufacturing train with 10,000 liter reactors and associated filter dryers. 2. A new standalone raw material storage building with associated automation and amenities...

REGULATORY SPECIALIST • part time • familiar with 13485 compliant QMS program. • Since products are sold into the Canadian market, familiarity with the Canadian Medical Device Regulation (CMDR) SOR 98/282 and MDSAP is important. • knowing ISO 13485 PRECISION LIFE SCIENCES

Field Applications and Support Engineer A digital imaging technology company partnering with pathology labs and medical centers to enable digital transformation within the tissue processing lab. Takes on the challenges involved with digitization, organization, and management of whole slide images of glass slides that have normally been used for microscope examination - all while helping the labs...

Biomedical Instrumentation Specialist   General Summary   Installs, calibrates, repairs and inspects imaging devices, robots and computers and solves moderately complex problems in the field. Performs repairs up to and including the diagnosis and repair of difficult technical instrument and software problems. Participates in product improvement discussions, provides inputs to design engineerin...

Scientist / Senior Scientist, Upstream Development Seeking an experienced, highly motivated individual for the role of Scientist / Senior Scientist, Upstream Development. In this position, you will develop and implement suspension mammalian cell culture procedures for expression of novel gene therapy technology platform. Candidates should have expertise in early phase upstream development with...

1. Must have pulmonary hypertension experience 2. Goal: to supplement monitors (22 sites total; 18 sites enrolling) 3. Duration: Start ASAP 4. Monitoring frequency: CRAs need to be in contact with their sites weekly. CRAs should be on site every 2-3 weeks (to review eligibility for each new subject) Parsippany, NJ  

Quality Engineer   Qualifications: Bachelor’s degree in Engineering discipline or equivalent. Up to three years of related experience and/or training; preferably in the medical device industry related to process/quality engineering. Knowledge of basic mechanical testing and material properties. Knowledge of metrology. Familiar with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO...

The primary responsibility of the Medical Science Liaison (MSL) is to act as a liaison with nationwide and regional key opinion leaders (KOLs) to align interests, discuss research and medical information, and to facilitate both clinical trial efforts of the company and Investigator-sponsored studies in relation to the treatment of pancreatic cancer. This individual’s clinical insights will be...

Description: The Director, Toxicology is a key member of preclinical development teams and be responsible for the strategic planning and execution of nonclinical safety plans of the portfolio programs supporting late discovery through first-in-human and proof-of-concept clinical studies of investigational antibody oligonucleotide therapeutics to treat serious muscle diseases. The person in this...

Requirements: Provide QC oversight in a compliant manner   • Observe the packaging process and packaging activities for company products (generics) • Perform random reviews/observations to verify training, documentation etc • Observe the operations including in-process challenges, checks and inspection • Report deficiencies to Legacy management representative and ensure appropriately...

Precision Life Sciences is seeking a Senior Director of Clinical Operations to provide strategic leadership for the planning, oversight, and successful completion of all of our clinical trials and clinical trial related milestones within established budgets and timelines. Reporting to the Chief Medical Officer, this position will be highly collaborative, working cross-functionally with many...

Engineer, Test N02   Qualifications:   Education: • BEE BSCS (or equivalent) preferred but not required   Experience: • Minimum of 1-3 years' experience with test plan creation and execution using problem tracking software for reporting and analysis • Experience with setting up computer and client networks • Strong familiarity with operation installation and administration of Windows...

Senior Scientist- Physical Sciences   KEY RESPONSIBILITIES • Leading customer projects (primarily pharmaceutical) and interfacing with clients as a key contact • Synthesizing background information, designing experiments, and writing study protocols • Critically analyzing chemical and physical stability data • Modeling data derived from experimental results using statistical...

Reporting to the Vice President, Computational Chemistry, the candidate will play a key role in the ongoing development of RNA structure-based design platform and drug discovery endeavors. Central to this will be the advancement of our understanding of RNA binder molecular dynamics and SAR using state of the art computational chemistry software. A key aspect of this position is teamwork and the...

Repair of computers, control systems, monitoring equipment and ancillary components used in the MRI/CT suite of controls. Typical systems would include Image Reconstruction Systems (IRS), Image Control Systems (ICS), Data Acquisition and Recon Control systems (DARC), Image Generators (IG), Image Compute Nodes (ICN), SCSI Towers and HP host computers. You will use oscilloscopes, meters, network...

Manager / Lead Associate, Demand Planner Demand Planner - Responsibilities: • Review historical sales trends, research demand drivers, prepare forecast data, develop statistical forecast models, and evaluate forecast results. • Coordinate between cross-functional teams to reconcile significant variances and refine the forecast model to reflect updated sales and marketing assumptions. •...

Quality Control Supervisor    JOB DESCRIPTION: Position: Quality Control Supervisor PRECISION LIFE SCIENCES The Quality Control Supervisor will oversee, manage and provide direction to the QC department that will effectively meet or exceed the internal expectations by providing superior quality products and service. The Quality Control Supervisor will collaborate with Supplier Quality,...

The Director, Precision and Translational Program Management assumes the role as the lead on translational program management, accountable for both the leadership of the overall team and as needed, aspects of a translational program. You will use translational knowledge and expertise of the applicant to help develop the translational program management function and streamlined execution across the...

Precision Life Sciences is working with a client, in the life science / biotechnology industry, for a contract, remote Senior Principal Biostatistician. The position will provide oversight on clinical studies and provide statistical support on the development of in-house clinical studies and projects. The positional is responsible for designing, implementing, and reporting in a quality, timely and...

 Precision Life Sciences is working with a client seeking various Stat Programmers from Sr. Manager to Assistant Director to Director.  These roles are remote or hybrid and are contract-to-hire or direct hire. Overall responsibilities include: • In collaboration with the Statistical Programming therapeutic area units (TAUs) lead, these positions serve as key contributors to the development of...

Lead, Quality Systems Purpose: The Lead Quality Systems will lead, execute and maintain QMS processes (Deviation, CAPAs, Change Control, Documentation & Training). Will be responsible to monitor QC, QA activities and other GMP functions of internal quality management system for compliance and provide oversight of external partners for thorough and timely closure of the Quality system elements in...

Our client, in the biotechnology / life sciences industry, is seeking an Associate Director, Statistics (contract to hire). POSITION ACCOUNTABILITIES: • Serve as global statistical lead for biomarker development in Oncology Cell Therapy and TA. Provide statistical leadership and support for internal decision making, regulatory meetings, submissions, and follow-up. • Review key program...

Our client, in the biotechnology / life science industry, is seeking a contract Clinical Trial Manager OR Clinical Operations Lead (COL) to serve as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study(ies). The position as defined by scope provides leadership, mentoring, and technical support to the Clinical Operations team to ensure the...

The In Vivo Technologist II, in accordance with Good Laboratory Practice (GLP), works under limited supervision and is responsible for performing advanced bio methods and/or humanized procedures, such as bioluminescence imaging, drug formulation, aseptic; and shipping animals domestically and internationally under strict regulation. Additional responsibilities include taking on a project lead role...

The Senior Manager, Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance department for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Clinical Trials and post marketing (where applicable). What...

Quality /Regulatory Manager   Job Position Summary: The Quality /Regulatory Manager shall be responsible for “hands-on” oversight and continued implementation of the Company’s existing Quality Management System (QMS) certified to ISO 13485:2016 and meeting the MDSAP regulatory requirements for the US and Canada and certification to ISO 9001:2015. The Quality /Regulatory Manager shall directly...