Manager, Upstream, Gene Therapy
Proclinical is currently recruiting for a Manager of Gene Therapy with a pharmaceutical company located in Sanford, NC. Successful candidate will be responsible for planning, organizing, staffing, performance assessment, salary recommendations, and employee counseling for a group of employees typically with similar technical responsibilities.
- Ensure a safe work environment. Ability to identify, evaluate, and correct potential hazards in the workplace is essential.
- Coordinate, schedule, and participate in daily activities of cGMP production in the manufacturing area to meet supply chain needs.
- Ensure that product quality is maintained through all phases of process validation and commercial production, including operational parameters of manufacturing equipment, personnel activities, batch record/processing dynamics, and integrated utilities to identify and resolve quality risk to commercial manufacturing. General knowledge of scientific principles, production equipment & related procedures.
- Aid in investigations. Responsible for the adherence to established policies, procedures and practices. Participate in inspections and cGMP/Quality decisions effecting short-term production.
- Provide supervision to exempt and hourly direct reports. Motivate personnel by setting high standards and encouraging teamwork. Clear, unambiguous communication is critical.
- Primary contact for all personnel issues occurring within the department. Responsible for development plans and personnel reviews. Make initial decisions encompassing personnel issues, disciplinary actions, career advancement, educational assistance, and emergency situations (including injured employees, facility issues & inclement weather).
- Review completed batch records. Develop training material, update curricula, close training gaps, and support the training of new supervisors.
- Advise management of non-conformance issues and opportunities for continuous improvement
- Provide input on primary decisions on cGMP related documents developed or revised.
- Articulate challenges and solutions to technical and non-technical peers and to department management.
Skills and Requirements:
- BS degree with 5-8 years of FDA/GMP manufacturing experience required. MS degree with 3-5 years of FDA/GMP manufacturing experience may also be considered.
- 2+ years supervisory or management experience is required.
- BS and/or MS in science or engineering field preferred.
- Must have hands-on experience with adherent and/or suspension cells from flasks to large-scale bioreactors.
- Must have experience in upstream process and equipment troubleshooting.
- Working knowledge of biotechnology product manufacturing in a cGMP environment preferred, including solution preparation in single-use bags and/or stainless steel bioreactors, CIP, pressure test and SIP of bioreactors.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Paige Sanderson at (+1) 646-367-2618 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.