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 leader of the Manufacturing Sciences & Technology department is responsible for managing a diverse range of projects and people that spans from technology transfer activities to post commercialization improvements. The complexity of the work demands a solid technical background across a variety of scientific disciplines and fundamentals (manufacturing process technologies, biopharmaceutical best practices, lyophilization, formulation development, validation, statistical analysis, regulatory submissions, etc.). Additionally, this role has asset and cost center management responsibilities that requires a fundamental understanding of budget management including both OPEX and CAPEX forecasting and planning.
More specifically on the technical side, this department provides technical support across several development programs and continuous improvement initiatives covering both processes and methods. Members of this department work closely with technical representatives from other Emergent sites, Customers, as well as cross functional teams on the Rockville site. The nature of these initiatives is often technically challenging and requires strong leadership attention to quality, time and budget.
Most importantly, strong people leadership skills are essential for the leader of this department. This position includes leading a team comprised of engineers and scientists covering a diverse range of experience and education levels. It is essential that this leader creates and engaging workplace with a strong focus on developing and empowering people. This leader will have involvement on relevant steering and core teams to ensure proper alignment of team resources and prioritization of work.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Routinely present our technical capabilities to external clients/customers
• Routinely interface with clients/customers on project or program progress
• Participate on Site Leadership Team to ensure appropriate alignment of resources to technical challenges and routine operational needs
• Maintain good working relationships with internal and external partners/customers with MS&T (Camden, Bayview, EPDG, QC, Mfg, etc.)
• Responsible for working with applicable Project Managers to ensure departmental resources are appropriately allocated based on work scope and technical needs.
• Ensure fiscal responsibility by developing and monitoring spend-to-budget as well as effective management of assets and accurate/timely allocation of resources
• 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.
• Track and report status on KPIs relevant to department activities/responsibilities and ensure commitment to key stakeholders are met in a timely and quality manner
• Lead development of standards including system, tools and templates across site for technology transfer through validation related activities
• Promote knowledge management and sharing of best practices related to tech transfer, formulation development and validation across sites
• Drives and implements industry leading practices and identify leading edge innovations for division related to method/process validation, technology transfer, life cycle approach utilizing QbD, Six Sigma and LEAN principles.
• Use sound judgment and data analysis skills to resolve problems and make routine and advanced decisions independently
• Works effectively within quality systems to drive quality outputs and efficient project execution
• Prepares CMC section content for applicable regulatory submissions.
• Assess new regulations and guidance on qualification/validation to ensure compliance.
People Management/Employee Development
• Builds a strong working environment that promotes our core values and progresses our culture in a positive manner (healthy cross-functional teamwork)
• Must be able to set and communicate department vision & direction that aligns to company & site strategy including setting of short and long-term department and individual goals
• Capable of leading change in a positive manner through department
• Ability to identify and manage talent through requisite HR systems (hiring, compensation, performance management and development) in ways that provide value to both company and employees
• Manage the IPMP for direct reports and mentor associates to facilitate professional and departmental growth
• Good interpersonal and communication skills (oral and written)
• Effectively administer IPMP and monitor staff performance in alignment with defined expectations.
• Must possess ability to negotiate and influence others internally and externally
Requires vaccination against different viruses including Vaccinia virus.
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
• A degree (Bachelor to Ph.D.) in a related field with a minimum of 8 years industry experience
• Experience in managing scientists/engineers in a fast paced, challenging environment
• Proven track record of management and leadership effectiveness
• Strong knowledge of lean & QbD principles in a manufacturing environment with successful application experience
• Diverse and demonstrated technical knowledge with strong risk management mindset
• Strong technical and communication skills: oral/written and listening
• Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability
• Computer skills (MS Office, JMP statistical software, Visio, MS Project)
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.