Minaris - Director, Commercial Manufacturing Operations

Director, Commercial Manufacturing OperationsThe Director, Commercial Manufacturing Operations is responsible for managing day-to-day operations of the department to ensure timely delivery of client-sponsored projects. Incumbent is a change agent responsible to interact with clients, provide strong technical leadership and collaborate effectively across groups within the organization.The incumbent is responsible for leading the organization into a data driven, team-oriented culture that embraces continuous improvement and drives quality, supply, and financial performance of the Commercial Operations team.This managerial role provides leadership on the GMP and non-GMP facility environments and contributes to management goals and improvements.Responsibilities:Responsible for developing and adhering to Operations resource models, input into the development of prospective / existing client proposals, Manufacturing Service Agreement (MSA) and Scope of Work (SOW). Execute agreements ensuring both client expectations are met and agreed upon for the profitability and success of the projectMember of Site Leadership Team.

Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectationsEnsures safe, quality, and timely manufacturing of biopharmaceutical products for pre-clinical, clinical, and commercial useLead all aspects of the Production Planning for the siteEnsures that all production operations are controlled and executed within GMP regulatory guidelinesDevelop and implement facilities policies and practices (SOPs)Deliver departmental goals and objectives based on compliance, milestones, and revenue targetsAccountable for the tracking, trending, and improvement of the Operations KPIs, driven by cost-effective and efficient output of client's productsProvide strategic direction and set objectives to meet financial and operational requirements that are aligned with Site and Regional targetsWork directly with internal and external stakeholders on projects of existing and prospective clients to ensure appropriate capacity, improve quality, adequate sourcing of critical deliverablesWork directly with Quality Assurance, Quality Control, MSAT, Project and Account Management and Manufacturing Support groups to ensure smooth tech transfer of client-sponsored projectsQuality Mindset:Works with Quality organization to set the standard for a quality mindset within the Operations organization. Ensures accountability to the quality culture fostered at the siteEnsure all processes and procedures related to Operations are in full accordance with GxP, CFR, site quality systems, company policies and promote a culture of quality, compliance, and excellenceSet expectations for operation excellence and Right First Time (RFT) executionEnsure staff is trained and qualified in GxP regulations and all SOPs related to performance of duties through training programs; create and monitor training curriculaRepresent Operations during audits and visits.Ensures Operations area is kept in a cGMP state through coordination of preventive maintenance and cleaning activities with the Facilities departmentLeadership Excellence:Provides leadership to direct reports and Commercial Operations team by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their bestDrive education and execution of company mission and vision within the OperationsLead by example and emulate the company's core leadership valuesLead a High-Performance Team culture within the Operations Leadership team.Ensure staff has the proper training, skill set, and personal development opportunities to assure their ability to carry out assigned tasks in compliance with Minaris procedures and policy as well as local, federal, and global regulations and industry standards.Lead a learning environment whereby team members are enabled to increase their skills and contributions to the Operations KPIs.Collaborate within the organization to manage the interface between cross-functional teams to align the functional strategy with the site and regional goalsProvide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectationsProvide direction and leadership for change management initiativesEnable teams through mentoring and coachingFinancial Stewardship:Responsible for achieving of financial goals for the site/facilityRecommends and manage capital requirements to maximize financial returnsActively involved with Sales and Account Management teamsResponsible for productivity and staffing that is appropriate to achieve regional/site/facility fiscal g goalsMonitor compliance to project budgetsMaintain and support client satisfaction at a level that ensures account retentionDevelop a mechanism to capture and track benefits/savings associated with operational improvement initiativesMonitor business and project activity to assure organizational improvement efficiency gains and cost savingsIdentify areas of fiscal waste; develop mitigation strategiesQualifications:Bachelor's degree or higher in relevant life science discipline8-10+ years' direct experience working in a GMP regulated facility in the pharmaceutical or biotech commercial manufacturing environment is a must2+ years' experience working in cell processing, cell culture, cell analytics, and related GMP technologies, preferably for the manufacture of cell therapy products; Hands on experience with autologous and/or allogeneic cell therapy manufacturing processes is preferredSignificant knowledge and understanding of CDMO operations and ability to work effectively and collaboratively with our partnersExperience in strategic planning, process improvement, project execution, and data/business analyticsAbility to provide technical solutions to a variety of technical challenges of low complexity scope and the ability to suggest improvements and adaptations to methodologies, processes, and productsDetailed knowledge of manufacturing technology, industry trends and requirements associated with the introduction of new equipment, systems, and processes into a manufacturing settingExcellent oral and written communication skills including proven track record in meeting facilitation, training and presentationDemonstrated success initiating change and influencing at all levelsComprehensive understanding and extensive practical experience with GMP quality systems and proceduresAbility to adapt and evolve quickly in an ever changing and dynamic environmentSelf-motivated and able to collaborate well cross-functionally with other department managers and personnelSelf-awareness, integrity, authenticity, and a growth mindset; Willingness to accept temporary responsibilities and assignments outside of this job descriptionCompetencies/Candidate Profile:The ideal candidate is seasoned and well versed in GMP facility operations management within the biotech or pharmaceutical industriesCollaborates with other team members and demonstrates outstanding interpersonal skills; Ability to effectively interface with peer groups in the site and work collaboratively to achieve site goalsAn innovative, motivated, and independent leader with proven ability to work cross-functionally and drive accountability, proactive problem-solving skillsDemonstrated ability to work creatively and effectively in a fast-paced CDMO environmentDemonstrated leadership abilities, and the ability to work in a matrixed and collaborative environment; Ability to lead through influenceStrong business acumen to handle internal and external stakeholdersAbility to think strategically and act tactically (detail-oriented)Strong interpersonal, communication, and analytical skills, capable of producing executive-ready presentations with little guidanceComfortable translating ambiguous direction and high-level goals into actionable projects/initiativesBias for action and solutions; Ability to partner with leadership, managers, and process owners to execute on cross-functional goalsRecognized skills for ability to develop efficient operations with robust processes and implementation of operational KPIs focused on Right First Time and On-time delivery.Strong attention to detail while having the ability to work simultaneously on multiple prioritiesDemonstrated customer (internal and external) interaction skillsExcellent skills using Microsoft Office SuiteSupervisory Responsibility:Manufacturing ManagersSupervisorsManufacturing Associates/LeadsAseptic SanitizersMinimum Required Training:N/AWorking Environment:Must have