Associates of Cape Cod, Inc.
Last Updated 24 May 2017
SUPERVISOR/SENIOR QUALITY CONTROL ANALYST
(posted 27 OCTOBER 2016)
Candidate will be responsible for the review, interpretation and trending of data from chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples in accordance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Candidate will schedule all group activities, personnel management, training and support, and coordinate testing priorities with other departments. Candidate will also conduct performance management and development, including performance reviews and objectives, interviewing and hiring. Bachelor's degree in related science field with 6+ years of experience in the medical device, biotech or pharmaceutical industry, advanced degree preferred. At least 2-4 years of supervisory experience preferred.
- At least 2-4 years of supervisory experience preferred.
- 6+ years of experience in the medical device, biotech or pharmaceutical industry
(posted 24 OCTOBER 2016)
This position is responsible for the design, execution, scale-up, validation and tech transfer of new and current process systems to support manufacturing activities and to develop manufacturing processes for high volume and throughput. Ideal candidate will require 5-8 years of pharmaceutical/biotech engineering in the successful transfer of technology from R&D, Product/Process Development into Manufacturing and insure that standard operating procedures comply with cGMP, ISO 13485 and other applicable national and global requirements. Direct, coordinate and conduct the process improvement investigation activities of the Manufacturing area, personally or through cross functional staffing. Must have excellent knowledge of cGMP, ISO 13485 and production requirements. Detail oriented and excellent organizational skills. Excellent oral and written communication skills. Project/Program Management Skills in a team based environment. A minimum of a Bachelor's degree in an engineering discipline (preferable mechanical or chemical) or an equivalent combination of experience and/or education required, Masters a plus. Must have experience with production methods and manufacturing systems. Possess at least five years' experience in medical device, biotech or the pharmaceutical industry. Must have at least two years of project management experience.
(posted 8 APR 2016)
Design and implement facility engineering projects in support of overall corporate objectives.
Knowledge and Skill Requirements:
- Knowledge of HVAC, chilled water systems, pure water systems
- Knowledge of production equipment including autoclaves, depyrogenation ovens, filling equipment, lyophilizers, capping and labeling equipment.
- Project management/team leader skills.
- cGMP and ISO requirements for clean room operations.
- A minimum of a Bachelor's degree in an engineering discipline or an equivalent combination of experience and/or education required.
- Minimum of 5 years' experience in a manufacturing environment.
- Proficient with AutoCAD.
- Hands on experience with facility and production equipment including preventative maintenance and troubleshooting and resolving equipment problems.
SR. MANAGER / DIRECTOR PRODUCT DEVELOPMENT
(posted 23 MAR 2015)
The incumbent will provide leadership in the managing development activities to ensure that projects transition from research to commercialization phases meeting all the company requirements. This position will include a combination of technical development activities and project management and will require significant cross-functional interaction with R&D, Manufacturing, Engineering, Clinical Development, Quality and Regulatory departments. The manager will contribute significantly to formal investigations from both scientific and development perspectives. General responsibilities for this position focus around ensuring the appropriate development activities are planned and executed during the development of new products, new processes and improvements to existing products and processes through the validation process phase. The manager will have experience and expertise in processes associated with product development including Quality By Design, Design Control and Risk Management, and be able to drive these processes through the project management and change management processes. The manager will lead and supervise the activities of the development group as well as liaising with stakeholders in the process (R&D, Engineering, Production, Quality and Regulatory etc). The manager will also have experience leading and participating in significant cross-functional projects in a formal project management environment. Preferred candidates will possess a Ph.D. in an appropriate Science and will have at least 10 years experience in a regulated environment, with demonstrated success in product development. Must have excellent management skills in a team-based environment, good organizational, analytical and problem solving skills. Strong communication skills both oral and written. Must be comfortable delivering presentations to groups of all sizes. Experience in regulated environments: cGMP, ISO 13485 preferred. Candidate needs to be self-directed, timeline and deadline driven, have technical depth and strength, have supervisory track record which includes staff development, and have the vision and leadership to establish a strong product development function.
Associates of Cape Cod, Inc. is an Equal Opportunity Employer.