Manufacturing Lead

About Ferring: By building strong relationships within the scientific community, our medical affairs team has become a trusted partner among patient groups, clinicians and health policy decision makers. We pride ourselves on developing and disseminating information to our key stakeholders so that they can provide the best care for our patients. Because we oversee the entire lifecycle for many of our products, we’re on the forefront of developing valuable and scientifically grounded information that will chart exciting paths forward for many of our innovative brands. Join our expert team and drive innovation. Job Description: As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease. Ferring US is Great Places to Work® Certified. Earning this certification means that Ferring US is one of the best companies to work for in the country. Our people are at the core of what makes Ferring a great place to work. Putting people first, strengthening our workplace culture, and ensuring that it is a safe, equitable, and welcoming place to work is a priority at Ferring, and it always will be. Summary: The Manufacturing Lead performs activities under minimal supervision to ensure daily material planning and manufacturing activities for the completion of Rebiotix clinical and development drug products. This includes work on the manufacturing floor to produce Rebiotix products, as necessary. The Manufacturing Lead will lead multiple priorities in the production environment and is responsible for clear and timely communication of production status and issues to the Production Supervisor. The Manufacturing Lead will execute procedures in accordance with Rebiotix policies, procedures and cGMP. The Manufacturing Lead will be a member of the Operations group but may support other groups as needed such as Materials Management (packaging, shipping, receiving). This position reports to the Production Supervisor. The primary responsibility of the Manufacturing Lead is to manufacture clinical and drug products following cGMP (current Good Manufacturing Practices). The Manufacturing Lead will be responsible for executing protocols and batch records in accordance with Rebiotix policies, SOP’s, and work instructions. Responsibilities: The responsibilities of the Manufacturing Lead include but not limited to: Following Rebiotix safety policies Following the requirements of cGMP- ensures all manufacturing activities are performed following written procedures and reports infractions to Manager Leads, directs and participates in manufacturing operations including drug substance collection, drug product manufacturing, and cleaning Directs and assigns work to employees within their specific area/line as needed to reach production goals. Ensuring there is adequate employee coverage and informing the Production Supervisor of any employee absences during the shift. Provides training and development to new and existing employees to cultivate high performing teams. Ensuring the production areas are kept in a neat and orderly state Communicates daily production activities and performance against targets to the Production Supervisor Notifies Production Supervisor of any equipment malfunctions or problems that are impeding production. Monitors production activities for issues or concerns, communicates issues or concerns promptly to the Production Supervisor Collects and reviews all documentation at shift end to ensure processes were followed. Works cross functionally to ensure coordination of activities with QC, QA and R&D. Assists with Tech-Transfer as needed Documentation of all GMP activities OTHER JOB FUNCTIONS: Other duties and tasks as assigned Requirements: 3 years GMP Pharmaceutical experience 2 years experience with manufacturing processes Capsule Manufacturing experience preferred Familiarity with Lyophilization processing is preferred cGMP manufacturing experience Experienced in a controlled, regulated work environment Must have excellent communication skills Experience with technical documents and technical reports Must be detailed oriented and able to follow specific work instructions Experience with MS Office applications Must be detailed oriented and able to follow specific work instructions Must be able to accurately perform calculations per batch records Must be able to sit or stand for 8-10 hours per day, can lift items up to 25 lbs., and perform functions at a significant work pace to meet deadlines as established Prospective new hires for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required on your start date unless an exemption has been approved by the Company as a medical or religious accommodation. Join our team and you’ll become part of a close-knit community – one in which you’ll be listened to and your contributions valued. If you love to come up with new ways to make a positive difference and see them through, welcome to the team. We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace and perform pre-employment substance abuse testing. Location: Roseville, Minnesota Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring employs over 6,000 people worldwide, has its own operating subsidiaries in more than 50 countries and markets its products in 110 countries. Learn more at www.ferring.com and @Ferring, or connect with us on Facebook, Instagram and LinkedIn. As a leader in reproductive medicine and maternal health, Ferring commits to standing up for our patient communities, now and always. Empowerment We create leaders and entrepreneurs We empower, we boost our teams, we incite learning. Innovation We experiment and build our future We search for new solutions, we take risks for innovation, we learn. Accountability We own everything we do with courage We seize responsibilities, we are accountable for our decisions. Collaboration We are in this together We work together across teams, functions and geographies. Transparency We listen and share We communicate honestly, we do it often, we make it simple. Purpose We share one Mission, we are guided by the Ferring Philosophy We know why we are here, we inspire each other. Don't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit!