Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Manager, Functional Test Lab (ADD) position oversees Functional Test Labs at various Rockford locations. This includes executing Stability and Release testing for the Laboratory and supports ongoing and new Laboratory projects. This position may also oversee any testing performed by third party laboratories as required. This position will require training of analysts in techniques for which competency has been demonstrated. In addition, the Manager of the Functional Test Labs will participate in authoring/review of nonconformance investigations and assist in the determination of root cause. Review and approval of technical data and calibration documents is required. This role is customer facing with involvement in project management, method transfers, method validations, and weekly internal/external customer contact. In addition, co-ordination and scheduling service engineers to ensure that equipment down time is kept to a minimum is required. Knowledge/expertise relevant to methods, metrology and instrumentation (such as Zwick, Instron, FTIR, HPLC, and analytical balances) as well as the medical device types noted is preferred. There are supervisory responsibilities. GENERAL RESPONSIBILITIES Manages a team of 5-10 Analysts/Supervisors or other managers who are responsible for oversight or performance of Functional release and stability testing. This includes oversight of 1st shift and 2nd shift. Knowledge of ISO 17025, ISO 13485, ISO 11608, ISO 11040, USP/EP general chapters and ICH guidelines. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Partners with Assembly Drive Analytical/Micro testing laboratories to ensure customer requirements for testing are met. Implements best practices in Laboratories across multiple sites to maximize operational efficiency. Creates an environment to support a high awareness of housekeeping and safety, security. Maintains focus of zero laboratory safety incidents. Prioritizes resources in the department across multiple locations to ensure adequate resources are available for both personnel and equipment to meet customer requirements in order to deliver on time test results with optimum customer services. Ensures that staff are properly trained to perform their assigned duties. Demonstrates good leadership through effective planning, leading by example, delegating and empowering subordinates appropriately. Manages subordinate performance daily, acting quickly and decisively when required to resolve issues. Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring and employee counseling. Reviews and approves time records, requests for leave and overtime. Creates an environment which supports and encourages continuous improvement to eliminate waste, improve productivity and reduce costs where possible. Ensure that all Company procedures and disciplines are complied with so that all analysis is performed in accordance with cGMP, customer and applicable regulatory standards. This position may require the individual to be on an on-call rotation schedule for off shifts, weekends and holidays in case of emergencies. Other overtime/weekend work may be required. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Director. SPECIFIC RESPONSIBILITIES General knowledge and skills of a wide variety of Functional and Analytical Tests for Stability and Release purposes which include (but are not limited to): US Pharmacoepia Testing, European Pharmacoepia Testing, ISO Standard Device Functional Testing (Cap Removal Force, Activation Force, Injection Time, Extended Needle Length, Dose Accuracy, Needle Guard Lockout), Physical Testing (Appearance, Odor, Weight Verification, Dimensional Verification), Identification by HPLC, FTIR and UV-VIS Spectrophotometer. Bench work in any of the above tests may be required. General knowledge and skills of analytical/functional test equipment and calibration processes as it relates to the following equipment: Zwick, Instron, HPLC, FTIR, UV-VIS and Analytical Balances. Ability to troubleshoot equipment issues. Perform test method development, validation and method transfers including authoring and/or technical data review of protocols and final reports. Leads development activities to drive future clinical and commercial businesses in functional test laboratory operations. Development of validated Microsoft Excel or LIMS/Test System integrations to reduce manual activities Reviews and approves product nonconformances and deviations. Reviews and approves stability protocols and stability summary reports. Develops training programs and trains analysts on techniques and methods of analysis for which competency has been demonstrated. Develop, manage and coordinate laboratory activities with all PCI facilities and internal customers. Drives on time completion of testing and data correction activities of all personnel performing testing in the Department to meet customer deadlines. Assists with submission of capital expense justifications. Participation in the introduction of new equipment, including authoring, execution and review of URS/IQ/OQ/PQ documentation and participation in Factory Acceptance Testing and Site Acceptance Testing for the new equipment. Ensures client deliverables and needs are met. Works with clients to resolve technical and service issues. Assists with Quality Assurance review of technical data for release testing, stability testing, method transfers, method validations and reports as required. Maintains metrics for Laboratory for companywide key performance indicators (KPI’s). Authors, reviews, implements and recommends process improvement changes to SOP’s and operational policies. Participates in department improvement initiatives and implementation. Hosting/participation in weekly project management calls with PCI customers. Monitors project timing and proactively takes action working with laboratory resources to prioritize client expectations to ensure quoted turnaround times and expectations are met to the extent possible. Provide support to PCI personnel and regulatory agencies during audits and project meetings as requested by senior leadership. Performs monthly invoicing in the absence of the lab management. Initiation and Management of Change Controls. Assesses other internal change controls for laboratory impact. Generates quotations for projects in area of technical expertise. Assists with determining appropriate pricing for various projects. Supports lab management to develop future growth plans and expansion of laboratory services. Serve as a Subject Matter Expert (SME) on laboratory processes and procedures For candidates in Illinois: This position's base salary hiring range is $97,280-$110,000 plus an annual performance bonus eligibility. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k. #LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.