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.
I. JOB SUMMARY
The Sr. Manufacturing Manager position is responsible for Line A and B fill/finish manufacturing operations encompassing formulation, filling, capping, inspection, and labeling & packaging. This includes management of manufacturing staff, manufacturing budgets, developing standard operating procedures and training, interacting with other departments and being on-call during critical process operations.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Provides hands-on management/supervision of manufacturing staff in the fill/finish operations involving with preparations, formulation, filling, capping, inspection, labeling and packaging.
• Involved as manufacturing SME in technology transfer for new product introduction and process optimizations. This includes supporting Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
• Will lead support groups on establishing/maintaining production schedule and performance metrics and goals
• Establishes performance standards and goals for Manufacturing Supervisors and Associates
• Demonstrates and enforces understanding and adherence to Emergent policies, GMP standards and safety procedures
• Hires, evaluates, trains, develops and terminates staff
• Oversee development and maintenance of management processes including, but not limited to: Employee job descriptions, Integrated Performance Management Process (IPMP) documentation, staffing models, resource allocation models.
• Effectively delegate decision making into the department. Empower direct reports to make level-appropriate decisions.
• Updates site leadership team on process status and achievement of objectives
• Resolves problems of manufacturing staff and manages manufacturing resources
• Develops and maintains manufacturing budgets
• Frequently Interacts with other site group leaders including Sr. Director and VP level staff
• Prepares and conducts technical presentations of manufacturing processes
• Performs annual performance appraisals of staff reporting to the position
• Generate Batch Records, SOPs and Protocols as required
• Reviews Batch Records, SOPs and Protocols as required
• Verifies manufacturing readiness including raw materials, staff training, suite cleaning and equipment operation
• Responds to or delegate duty as primary, manufacturing alarm response representative according to site alarm response policy
• Works with subject matter experts to trouble-shoot and/or optimize processes as required
• Supports Emergent QA during audits and regulatory inspections
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• BS degree in biology, chemistry or related scientific discipline
• Minimum 8 years of GMP pharmaceutical experience
• Minimum 5 years supervisory experience
• Experience in contract manufacturing operation of managing drug (small molecule), biologic, and vaccine development projects including technology transfer
• Excellent written and verbal communication skills
• Computer literate (Word, Excel and PowerPoint)
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.