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) preferred or advanced coursework/master’s degree in Work Environment or similar or ability to gain certification within one year of employment. • Working knowledge of federal,...

MINIMUM QUALIFICATIONS (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the, education, knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) • Bachelor’s degree, preferably in an...

MSAT Downstream Scientist/Engineer (Midlevel and Senior)   Key responsibilities: • Represents Manufacturing Science and Technology MSAT on project teams as technical subject matter expert SME and interface with customer technical and quality representatives. • Develops process understanding and expertise. • Authors, reviews, and owns process related documentation example process...

Packaging Engineer - Hybrid Diversity, Equity & Inclusion We are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. Purpose: We are seeking an Associate...

Remote - part time - Regulatory Bioequivalence Consultant We are currently seeking a highly skilled and experienced Regulatory Scientist to join our team. As a leading pharmaceutical company, we are dedicated to developing innovative and effective products for patient care. We are currently working on three products, including one emulsion and two suspensions. The emulsion product, a small...

MSAT Downstream Scientist/Engineer (Midlevel and Senior)   Key responsibilities: • Represents Manufacturing Science and Technology MSAT on project teams as technical subject matter expert SME and interface with customer technical and quality representatives. • Develops process understanding and expertise. • Authors, reviews, and owns process related documentation example process...

MSAT Upstream Scientist/Engineer (Midlevel and Senior)Submit   Key Responsibilities: • Represents Manufacturing Science and Technology MSAT on project teams as technical subject matter expert SME and interface with customer technical and quality representatives. • Develops process understanding and expertise. • Authors, reviews and owns process related documentation example process...

Regulatory Project Manager - Remote   The Regulatory Project Manager (PM) will work in close collaboration with Regulatory Strategy and Operational teams, as well as cross-functional teams across the organization (i.e., Clinical, Nonclinical, and Quality) to build and manage timelines to support regulatory filings through licensure and beyond.   Here’s What You’ll Do: • Define, manage, and...

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...

Project Electrical Manager The Electrical Manager reports to the Capital Portfolio Lead (CPL) and is a key member of the AZ project management team. The Electrical Manager works closely with Consultants, SMEs, the Client Contractors and their sub-contractors to ensure safe and successful project delivery by overseeing their delivery approach, management and deliverables during execution (construct...

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...

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...

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...

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  

We are seeking a highly skilled and compassionate individual to join our team as a Huntington Disease Medical Monitor. As a medical monitor, you will be responsible for overseeing our CRO partner and the medical aspects of clinical trials. Your role will involve monitoring participant safety, assessing study protocol compliance, and collaborating with the clinical research team to ensure the...

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

Senior Engineer, Quality Contract 5+years experience in medical device, experience in heart valve technology is a plus 5 days onsite Job Description Summary: Provide Quality Engineering support to various areas including design verification and validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non-conformance investigation, risk...

We are seeking a highly skilled and compassionate individual to join our team as a Huntington Disease Medical Monitor. As a medical monitor, you will be responsible for overseeing our CRO partner and the medical aspects of clinical trials. Your role will involve monitoring participant safety, assessing study protocol compliance, and collaborating with the clinical research team to ensure the...

We are seeking a highly skilled and experienced ALS (Amyotrophic Lateral Sclerosis) Medical Monitor to join our team and provide medical oversight and guidance to a Contract Research Organization (CRO). As an ALS Medical Monitor, you will play a crucial role in ensuring the safety and efficacy of clinical trials related to ALS treatments. This role is US based and it is expected the right...

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. •...

Reporting to the Vice President, Biometrics, the Associate Director, Clinical Data Management is responsible for leading all clinical data management activities for one or multiple projects including CRF design, database development, processing external data, medical coding, data review, SAE reconciliation, and database close/lock procedures in accordance with ICH Guidelines and company requiremen...

Quality Vendor Manager We are looking for a seasoned Quality Compliance professional who will provide assessment on company sites, internal GMP departments, external partners, and quality systems for ensuring compliance with regulatory requirements and expectations, standards, industry trends, and regulatory commitments as well per company policies and procedures. Incumbent will support readiness...

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...

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,...

R&D Compliance & Risk Management - REMOTE   OBJECTIVES/PURPOSE • The R&D Compliance and Risk Management role is responsible for leading the R&D Quality QCS team in key compliance systems including Change Control and Risk Management and is considered a leader within these core compliance systems. • The role is a key member of the R&D Quality organization, leading matrix teams to promote...

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...

Seeking a highly motivated molecular biologist and biochemist to play a key role in advancing the ongoing cross-functional drug discovery & development efforts. This position will report to the Senior Scientist II and will be responsible for establishing innovative assays utilizing fundamental molecular biology and biochemical technologies.   Accountabilities & Responsibilities:   •...

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...

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 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....

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...

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...

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...

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...

Associate Director/Director, Clinical Quality Assurance   PURPOSE OF JOB: Seeking an Associate Director/Director, Clinical Quality Assurance (QA) reporting to the SVP of Regulatory Affairs and QA. The successful candidate will work cross-functionally to develop and implement quality systems and processes to meet all US, EU, and global requirements. The position involves managing and...

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...

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 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...

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...

Job Summary: We are seeking a highly motivated and detail-oriented Quality Analyst to join our life sciences company. The Quality Analyst will be responsible for ensuring compliance with regulatory requirements and industry standards, and for monitoring and improving our quality management system.   Key Responsibilities:   Develop and maintain quality control procedures to ensure compliance...

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...

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...

Director, Regulatory Affairs Advertising and Promotion The Director of Regulatory Affairs, Advertising and Promotion will help determine the promotional strategy for assigned products and therapeutic areas. They will also review promotional, educational and scientific communications for products and therapeutic areas of interest to ensure accuracy and compliance with applicable laws and...

Position Summary: The US Medical Reviewer, Senior Manager, reports into the Sr. Director, US Medical Information and Patient Safety. He/she is an office based professional with scientific, clinical and therapeutic area understanding who is responsible for leading the medical review of promotional and medical materials across disease areas. This individual will represent US Medical Affairs in...

MINIMUM QUALIFICATIONS (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the, education, knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) • Bachelor’s degree, preferably in an...

The Director, Medical Affairs, Oncology Solid Tumors will oversee all US medical affairs activities related to metastatic pancreatic cancer. The Medical Director is responsible for driving the medical strategies for the overall US Medical Affairs plan, including cross collaboration with key internal partners as well as managing relationships with key opinion leaders. This role works closely with...

Project Manager - Supply Chain Qualifications: Skills required • Working experience in project management on global scale • Excellent communication and presentation skills • Good written and verbal communication skills • Solid organizational skills including attention to detail and multitasking skills • Strong working knowledge of Microsoft Office • Negotiation skills on stakeholder level ...

Regulatory Project Manager - Remote   The Regulatory Project Manager (PM) will work in close collaboration with Regulatory Strategy and Operational teams, as well as cross-functional teams across the organization (i.e., Clinical, Nonclinical, and Quality) to build and manage timelines to support regulatory filings through licensure and beyond.   Here’s What You’ll Do: • Define, manage, and...

Senior Clinical Trial Manager   Overview: We are seeking a highly skilled Clinical Trial Manager to lead and manage clinical trials in accordance with Good Clinical Practice (GCP) and regulatory requirements. The successful candidate will be responsible for ensuring that clinical trials are conducted efficiently, within budget, and in a timely manner, while maintaining high-quality data.   ...

Quality Vendor Manager We are looking for a seasoned Quality Compliance professional who will provide assessment on company sites, internal GMP departments, external partners, and quality systems for ensuring compliance with regulatory requirements and expectations, standards, industry trends, and regulatory commitments as well per company policies and procedures. Incumbent will support readiness...