We're looking for a Support Operations Manager, working in the Pharmaceuticals & Medical Products industry in Exton, Pennsylvania, United States.
Manages buffer and media weigh/dispense/production suites, clean/sterile assembly preparation, raw material sampling and dispensing.
Drives the design, acquisition and implementation of new technologies for buffer and media preparation.
Provides direct supervision, training, and hands-on support of production staff in the operation of equipment to support preclinical, clinical phase, and commercial launch batches of all materials.
Coordinates and supervises department change-over activities.
Serves as the equipment and suite owner to coordinate routine suite and equipment maintenance, calibration, and validation with appropriate internal departments.
Coordinates the preparation/revision of master batch records, SOPs, and review/close-out all cGMP documents, including equipment and process deviations for each campaign.
Assists in troubleshooting equipment issues and batch/material related deviations.
Provides timely reporting, investigation, and resolution of manufacturing process/product deviations, change controls, and commitments.
Ensures adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines.
Interacts cross-functionally with Upstream and Downstream Operations, Facilities, Quality Assurance, Quality Control, VTE, and other internal and external functions to support successful batch production.
Recruits, trains, and develops staff supporting operations.
Ensures staff are trained in cGMPs, process specific knowledge, equipment operation, and relevant regulations.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years’ experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Bachelors degree in Biological Sciences or Engineering, Business or Technical Management
Minimum of 5-8 years in a multi-discipline cGMP production environment, initiating, scheduling, and managing Biopharmaceutical product manufacturing functions
Knowledgeable in operation of washers, sterilizers, and buffer/media single use solution prep equipment
Knowledgeable in cGMP equipment validation, trouble shooting, and maintenance
Ability to identify, investigate, and solve process, product and equipment problems
Strong working knowledge of US cGMP, EMEA, and JP regulations
Excellent written and communication skills
Excellent interpersonal skills
Team player who can excel in a hands-on entrepreneurial environment
Previous supervisory experience
Ability to train and develop subordinate technical staff
Fitness for the use of chemical safety respirators for solution handling required
The pay range we're offering is 104,000 per year.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.