<p>General Information</p> <p>Country United States</p> <p>City Pennsville, New Jersey</p> <p>Functional Area Research & Development</p> <p>Job Group Quality Control</p> <p>Employment Type Permanent Contract</p> <p>Working time Full-time</p> <p>At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.</p> <p>Your role</p> <p>SUMMARY:</p> <p>The incumbent demonstrates proficiency through a wide exposure to pharmaceutical analyses and has a firm grasp of scientific principles and skill in applying this knowledge. The incumbent has practical experience in pharmaceutical analyses and routinely performs analysis in the functional areas of HPLC, GC, and Wet Chemistry. The incumbent performs and trains on routine chromatographic analyses. The incumbent supervises and manages up to 5 direct reports.</p> <p>ESSENTIAL DUTIES AND RESPONSIBILITIES:</p> <ul> <li>Supervises and manages the QC Finished Product team. </li><li>Supervises daily activities in the QC laboratory, including sampling, testing, and documentation. </li><li>Schedules/assigns work to direct reports. </li><li>Performs analytical/wet chemistry testing on raw materials, final dryers, and finished lots approximately 50% of the time. </li><li>Sends samples out to external testing laboratories when needed. </li><li>Provides analytical/wet chemistry support for production. </li><li>Ensures all analytical testing (HPLC, GC, FTIR, UV, KF, etc.) is conducted as per validated testing methods and regulatory standards. </li><li>Ensures proper handling and disposal of chemicals, reagents and hazardous materials. </li><li>Responsible for investigating DEA related issues in the QC Lab. </li><li>Review and approves analytical data and test reports. </li><li>Initiates and authors OOS/OOT investigations, lab events, and deviations in conjunction with the QC Manager/Director. </li><li>Supports and participates in internal and external audits by preparing and providing the necessary documentation. Addresses compliance gaps as needed. </li><li>Supports Analytical and Chemical Development by testing/scheduling sample analyses. </li><li>Reviews/approves change controls for method updates via Trackwise and LabWare. </li><li>Assists in writing of SOPs, testing standards, protocols and reports. </li><li>Assists in SOP/documentation updates, CAPA closures, and remediation plans. </li><li>Assists in training of lab personnel on instrumentation, methods, and cGMP. </li><li>Shares in the responsibilities of housekeeping (i.e. Glassware, waste, retains, etc.). </li><li>Provides ideas/feedback for areas where efficiency can improve. </li><li>Reviews and releases analytical results. </li><li>Performs any other laboratory tasks deemed necessary by the QC Manager/Director. </li><li>Adheres to personal moral, ethical, legal, and behavioral conduct that follows the Siegfried Code of Conduct. </li><li>Adheres to all applicable SHE and cGMP regulations. </li><li>Performs all tasks in accordance with cGMP compliance. </li></ul> <p>SUPERVISION:</p> <ul> <li>Supervises an QC team of approximately 5 chemists </li><li>Troubleshoots and assists in the resolution of issues with QC testing </li></ul> <p>Your profile</p> <p>EDUCATION AND EXPERIENCE:</p> <ul> <li>BA or BS in chemistry or related science and 6-15 years of work experience in a QC laboratory </li><li>In-depth knowledge of cGMP is a must </li><li>Experience with investigatory practices is desired </li></ul> <p>OTHER REQUIREMENTS:</p> <ul> <li>Must have excellent verbal and written communication skills </li><li>Must be able to work efficiently with people of all levels and cultures </li><li>Must be a team player </li><li>Must be very conscientious and detail oriented </li><li>Must be able to manage projects and prioritize appropriately </li><li>Must be able to work in a fast-paced environment </li></ul> <p>Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions.</p> <p>Working at Siegfried</p> <p>Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.</p> <p>Who we are</p> <p>In the Midst of People's Lives - Across the Globe</p> <p>The Siegfried Group is one of the world's leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model.</p> <p>The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers' value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production.</p> <p>We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.</p> <p>What we do in Pennsville</p> <p>Pennsville is our drug substance manufacturing site for the US mar-ket and provides spray drying operations globally.</p> <p>Main activities</p> <ul> <li>Pilot and commercial manufacturing of drug substances (APIs) and related intermediates </li><li>All fully cGMP and SHE compliant </li></ul> <p>Features</p> <ul> <li>3 GMP pilot suites: 0.1-2 m³ reactors </li><li>200m3 commercial capacity: 1-10 m³ reactors </li><li>Successful transfer of new products to the commercial scale - Powerful rectification </li><li>Spray drying in pilot and commercial scale for both isolation and dispersion technology </li><li>Micronization in pilot and commercial </li></ul> <p>Strategic importance</p> <ul> <li>CMO for innovative drug substances and manufacturer of our opiates portfolio for the US market </li></ul>