FDA certified pharmaceutical company is seeking a Senior Chemistry Lab Manager to develop a brand-new lab on site and lead and oversee the entire Analytical Chemistry Lab for a rapidly growing Sterile Pharmaceutical Company. This key hire must have in depth knowledge and experience in a cGMP, GLP testing lab procedures and related equipment for the purpose of pharmaceutical injectable stability studies and future product release. This key employee will help develop this Analytical testing laboratory from the ground up in regards to equipment, staff and SOP’s so a result driven approach and manager is needed. The Laboratory Manager reports directly to the Director of Quality and is responsible for overseeing and assisting with laboratory setups, maintenance of equipment and performing other job related duties as assigned.
Primary Duties and Responsibilities:
• Work alongside Quality Director and Sr. Management to develop a plan for this new business unit.
• Prepare budget and design laboratory based on the needs of the company.
• Help determine staffing model for lab and lead key interviews to quickly assemble a capable, skilled, and dedicated team
• Install HPLC, Mass Spec, IC technologies on site.
• Develop and quickly implement validation protocols on time.
• Ensure proper IQ, OQ, PQ’s are performed and well documented.
• Design Quality operations and lab to maximize efficiency, reduce OOS events, and ensure operational excellence as the growing organization will need.
• Maintain and repair analytical instrumentation.
• Assist and oversee construction of new equipment.
• Ensures that all products produced in the lab are produced, tested, and released in compliance with SOPs, cGMP and FDA regulations.
• Train and supervise support employees who prepare solutions and equipment.
• Maintain inventory of chemicals and laboratory equipment and manage the Lab stockroom.
• Select and schedule experiments complementary to company’s needs.
• Prepare and update lab sheets for each experiment.
• Process bids and purchasing for chemicals.
• Oversee disposal of chemical waste.
• Enforce departmental chemical safety practices.
• Remain up-to-date with changes in standards for chemical handling, storage and disposal.
• Development of wet chemistry lab, new team, validations, and related setup from infancy at new expansion facility.
• Masters in biochemistry, microbiology, or equivalent with a minimum of 8 years in sterile pharmaceutical experience.
• 8+ year working in CLP, cGMP Chemistry Lab Departments
• Analytical methods development and validation
• Present analytical data to senior staff for review and discussion
• Troubleshoot/improve existing analytical methods when necessary
• Perform analysis of raw materials, in-process, finished product and stability samples
• Work in compliance with cGMP/cGLP regulations
• Work alongside Pharmacy and Sr. Management to ensure timelines and product developments are happening on a timely basis and to the needs of the organization
• Train junior staff on analytical techniques
• Peer review of lab notebooks.
Required Minimum Qualifications
• Past experience in lab expansion or startup important
• In depth knowledge and experience in sterile parenteral manufacturing and all related cGMP requirements.
• Proven experience in managing and leading teams.
• Expansive knowledge and experience in validations of equipment, processes, testing, etc.
• Strong business insight with the ability to analyze and solve complex business issues across cross functional teams.
• Innate sense of urgency.
• Strong willingness to learn ins and outs of dynamic business.
• Willingness to travel some to existing location and be able to relocate to vicinity of new expansion facility in the Northeast (CT) in the Hartford area.