Manufacturing Supervisor (Cell Therapy CDMO)

Job Description

Job Description

"Bridging Innovation to Cure"Developing and manufacturing your cell therapies from benchtop to bedside"SummaryCellipont Bioservices is growing, and we are looking for a Manufacturing Supervisor who believes in the potential bridging of client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level. The Manufacturing Supervisor will provide hands-on direction for manufacturing personnel and activities. This position requires extensive technical expertise in aseptic techniques. Provide expertise in writing/reviewing SOPs, Batch Records, Deviations, CAPA's and other technical document/compliance documents as it relates to the Manufacturing Operations. The Manufacturing Supervisor is also responsible for ensuring all personnel activities are executed timely and cost effectively to ensure customer and stakeholder satisfaction. This role will also require the individual to demonstrate strong customer service capability, ability to work cross-functionally and possess strong leadership skills. The Role Oversee and schedule the manufacturing operations and personnelLeads a manufacturing team to identify issues and propose adequate solutionsResponsible for training manufacturing personnel on the use of the Batch records, scheduling, ordering of raw materials, components and supplies, setting up production batches, and maintaining inventoryEnsure batches adhere to established Quality standardsGMP batch review and close-out with Quality Assurance groupConduct interviews and provide input for hiring new manufacturing specialist.Provide daily production updates to production managers, client representatives, and project managersProvide guidance for continuous improvement initiatives within the Manufacturing teamRepresent the department to clients and on cross-functional project teamsMay operate production equipment and inspect, label, or package productsWork with Manufacturing, Quality, Engineering and Technology groups on issues and identifies process improvement opportunitiesEnsure the completeness and accuracy of manufacturing documentation per approved procedures.Identify and support the implementation of process efficiencies and areas for improvementEnsures solutions are consistent with organization's objectivesResponsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriatePerform additional duties as neededThe CandidateBachelor's Degree - Life Sciences or Chemical Engineering and minimum 5 - 7 years in GMP environment with experience in GMP manufacturing operations/Cell Therapy/Human Cell Cultivation. CDMO experience preferred.3 years minimum of leadership/management experience in a GMP environmentExperience in writing, executing and reviewing SOPs / MBRs while maintaining proper GDP guidelines.Good mechanical aptitude, familiar with general equipment associated with Cell and Gene Therapy Processing.Detail oriented and highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environmentMust be proficient in Word and Excel.Ability to interpret process trends and data and react appropriately to unexpected outcomes.Innovative spirit, strong initiative and work ethic, and positive attitudeAbility to work flexible hours and inconsistent schedules as necessary to meet production demands and timelinesMust be available to work 2nd shift (2:00 PM – 11:00 PM), Monday through Friday, with occasional weekend or holiday support as neededWork EnvironmentComfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing prioritiesAbility to work off-shift and extra hours as requiredWeekends & Holidays as requiredPOSITION BENEFITSOpportunities for career growth within an expanding teamDefined career path and annual performance review & feedback processCross-functional exposure to other areas of within the organizationRobust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members401K strong employer matchTuition ReimbursementEmployee Referral BonusesFlexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidaysGain experience in the cutting-edge cell therapy space"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"Notice to Agency and Search Firm RepresentativesCellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.