Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
Ensure the ongoing safe and compliant state of cGMP manufacturing processes as it relates to process execution and process performance. Develop, coach, and mentor staff members through routine 1-on-1 interactions, IPMP goals, and defined major responsibilities. The role of the Manufacturing Supervisor is to actively monitor and oversee activities in the cGMP manufacturing areas.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• From the cGMP manufacturing areas, directly oversees day to day manufacturing operation activities and verifies safe and compliant execution with cGMP standards and procedures.
• Supports the development and maintenance of management processes including, but not limited to: Employee job descriptions, Integrated Performance Management Process (IPMP) documentation, resource models.
• Assure communication of key Company/Department initiatives and objectives to staff .
• Facilitate Shift meetings and ensures that the appropriate level of communication is disseminated to the subsequent shift and other support departments regarding process and equipment status.
• Effectively delegate decision making into the department. Empower direct reports to make level-appropriate decisions.
• Identify and appropriately escalate issues in order to keep routine operations, projects and initiatives on schedule.
• Effectively collaborates and integrates information from support departments to position teams f or success.
• Provide resources and subject matter expert (SME) input to support continuous improvement, capital and corporate initiatives.
• Ensure personnel fully support compliance-based activities by maintaining current training requirements.
• Ensure the ongoing validated state of commercial cGMP manufacturing processes as it relates to process performance and process validation.
• Partner with Quality Assurance to ensure the highest level of compliance with cGMP with respect to the storage, use and documentation activities associated with the manufacture of bulk and finished product.
• Actively support and interact with the internal audit program as a means of driving continuous improvement throughout Manufacturing.
• Participate in and provide SME resources to support all regulatory audits and technical discussions.
• Track and communicate key performance indicators from tier 1 to tier 2 Integrated Process Teams.
• Real time, on the floor, Batch Production Record review.
• Participate with process performance monitoring.
Culture Management and Employee Development:
• Support corporate culture initiatives. Work effectively with peer management to build team relationships and position f or mutual success in alignment with Q12 principles .
• Actively support Lansing Great Place to Work programs through regular attendance, active participation in meetings, and implementation of concepts and principles in department management.
• Qualified Trainer development and routine assessment.
• Responsible f or directing the work of the team and managing their performance. Drives engagement of the team members by creating a positive work environment. Encourages the development and career growth of team members.
• Establish and maintain routine management tools and standards to assure that direct reports are utilizing common tools to track resources, time coding, and performance.
• Ensure successful IPMP process execution to drive consistency between company/department goals and objectives and day-to-day business operations.
• Effectively build and maintain working relationships between Manufacturing Operations and support departments.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor's Degree is a scientific/engineering discipline preferred or equivalent related experience in cGMP biologics/pharmaceutical manufacturing.
• A minimum of three (3) years of progressive leadership responsibility required in an industry-related environment.
• Knowledge of global regulatory requirements.
• Strong communication skills: oral/written and listening.
• Behavioral Competencies: Ensures Accountability, Drives Engagement, Communicates Effectively, Collaborates, Builds Effective Teams
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.