- Columbia, Columbia, MD, us
CP Professional Services (CP) is a full service Life Sciences Quality and Compliance consulting firm also offering Engineering headquartered in Sparta, New Jersey with offices in Florham Park NJ and San Diego CA. CP is committed to our clients and develops innovative strategies and targeted solutions necessary to exceed standards and our clients' individual needs, goals and expectations.
CP is ranked 3rd in the NJBIZ Top 50 Companies to Work for and is listed in NJBIZ 50 Fastest Growing Companies in NJ.
CP is seeking for our Bio-Pharmaceutical Client, one local Lab Manager for a 12+ month onsite assignment in Columbia MD. The client is interested in converting the consultant to a full time employee after six months of consulting.
This position is to manage the sites Biomedical Technology’s mechanical research laboratory whose primary role is to evaluate combination drug delivery systems through the use of sound, safe and justifiable scientific methods. Develops, evaluates and tests concepts, prototypes and ideas for new products and product improvements. The position will require that the staff utilize cGLP’s in its daily activities such that samples are tracked, tested/evaluated and technical memos or reports are written and supplied to the site Product Development and where applicable Quality, Technology and Manufacturing groups. Responsible for adhering to design controls and documenting all product development work in a Design History File.
- Manage a Combination Product laboratory to comply with cGLP’s
- Ensure staffing levels are adequate to support test requirements
- Ensure laboratory equipment is in compliance with The Clients requirements and maintained by the lab staff
- Manage an appropriate documentation system to comply with The Clients standards and where appropriate cGMP’s
- Manage sample control through utilization of a system to ensure all samples are logged in and stored in a controlled manner
- Manage the laboratory’s staff to use appropriate SOP’s, guidances and risk assessment files in the testing/evaluation of samples
- Manage the laboratory and staff to meet all The Clients/site Safety standards - EHS
- Manage the laboratory staff to evaluate Product development and where appropriate Complaint, Manufacturing and auto-injector defect samples. Ensure that the staff creates thorough and comprehensive evaluation reports with concise summaries explaining the lab’s findings
- Conduct testing where needed
- Manage the staff to create technical reports
- Review and approve laboratory memos and technical reports
- Candidates MUST SHOW ACCEPTABLE PROOF OF U.S. CITIZENSHIP / U.S. Lawful Permanent Resident Status and successfully complete a drug & background check
- Bachelor’s Degree in Biomedical Engineering or Mechanical Engineering preferred with 5 – 7 years experience in the Pharmaceutical Combination Products or Device industries.
- Masters Degree in Biomedical Engineering or Mechanical Engineering preferred with 3 – 5 years experience in the Pharmaceutical Combination Products or Device industries
- Conceptual design skills and experience with a variety of manufacturing methods (e.g. injection molding, machining, etc.)
- Experience in Human Factors and usability engineering
- Strong skills in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.
- Strong laboratory skills such as component inspection or failure analysis, mechanical testing, etc.
- Strong mathematical, analytical, and reasoning skills
- Strong problem solving skills
- Strong creativity and innovation skills
- Strong creativity astuteness
- Strong research skills
- Strong organizational skills
- Strong in team work
- Strong written and oral communication
- Experience in complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives
- Ability to prioritize multiple responsibilities and to work on multiple projects simultaneously
- Business acumen – demonstrates knowledge of market and competition
- Responds to requests for service and assistance with professionalism, courtesy, and confidence
- Laboratory management experience
- Capable of working independently with minimal supervision
- Strong presentation skills
- High level of attention to detail and accuracy
All your information will be kept confidential according to EEO guidelines.