Director, Manufacturing Technology
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.
We are seeking an outstanding candidate to join as a leader of our Manufacturing Science and Technology department. The candidate will lead a team of talented manufacturing professionals, scientists, and engineers responsible for end-to-end technical support of GMP manufacturing at Emergent’s site at Canton, MA. Candidates should have extensive experience with vaccines/biologics manufacturing in a GMP setting, scale-up and technology transfer and process validation, process troubleshooting, managing and mentoring staff, and supporting regulatory filings.
• Oversight for development and application of various manufacturing processes for commercial products in support of Emergent’s primary mission
• Lead a team of technical staff, engineers, scientists, and lab managers with expertise in upstream/ downstream manufacturing. Provide technical leadership, mentoring and coaching of departmental staff.
• Execute the MSAT strategy, including identifying resource needs and the hiring and management of employees
• Champion the presentation of updates related to process monitoring and project updates to management.
• Oversee the technical support for process-related investigations, product impact assessments, change control assessments, CAPA assessments, raw material qualification, etc.
• Coordinate studies and reports relating to process understandings, system capabilities and equipment performance through partnership with Production, Engineering and Validation.
• Offer subject matter expertise as a reviewer of project plans, technical reports/studies related to process understanding, regulatory submissions and validation protocols
• Effectively communicate with senior leaders, peers, staff and external organizations
• System owner responsibilities for multiple focus areas within the MS&T function (e.g. Process Validation, Technology Transfer, Cell Banking)
• Fostering an environment that encourages innovation with respect to identification, evaluation and implementation of new process technologies, new products, and improvement to existing commercial products
• Leading the development of strong rapport/collaborative relationships with external and internal partners (i.e. MS&T leaders/teams across the enterprise, internal customers, external agencies, and organizations, etc.).
• Management and oversight of small/mid-scale manufacturing Pilot Plant operations, ensure success of scale up/process transfer to routine CGMP manufacturing
In conducting these duties Director:
• Demonstrates leadership by ensuring decision making and communication are consistent with Emergent’s vision and values; influences, interprets and implements policies as directed by senior leadership team; and builds a strong working environment that promotes our core values and progresses our culture in a positive manner
• Provide fast-paced campaign support for manufacturing during technical production issues or escalations
• Work with manufacturing teams to provide technical support to manufacturing to develop platform procedures, batch records, training, and other manufacturing resources as required to prepare for and execute processes.
• Develop and draft study plans and protocols as required to support regulatory requirements, deviations response, process changes, etc.
• Develop and maintain structure for process data reviews for internal and external production
• Oversight for Process Performance Qualification (PPQ), Continued (Ongoing) Process Verification (CPV/OPV) and Annual Product Reviews (APRs)/Product Quality Reviews (PQRs/APRs) for all manufacturing processes/products.
• Oversight for introduction of improved drug substance manufacturing processes for products manufactured from a conceptual idea to regulatory filing.
• Strong technical and communication skills: oral/written and listening
• Computer skills (MS Office Suite, JMP statistical software, Visio, LIMS, SAP, etc)
• Understanding of MS&T concepts including but not limited to:
o Technology Transfer Strategy and Implementation
o Process Development, Product Process Improvement, QbD / PAT
o Process Characterization and Control
o Process validation
• Knowledge of key vaccines/biologics manufacturing technologies
• Experience with various regulatory agencies, audits and submission, particularly manufacturing process, methods, and or facility/equipment improvements
• Strong knowledge of regulatory guidance associated with process and method validation
• Direct process development, scale-up and process optimization activities, for example:
o Bioreactor operations, cell culture and virus culture activities, other unit operations such as single use mixers, cell disruptor, centrifugation, ultrafiltration/diafiltration. Development of pilot scale models of manufacturing processes.
o Lead complex troubleshooting investigations and drive process improvement initiatives.
o Write process development reports, engineering test protocols, simulation study reports, among others.
People Management/Employee Development
• Maintain the depth and scientific capability of the MSAT personnel pool. Promote and drive the technical and personal development of the personnel. Assure the number and skillsets of the resources are sufficient to serve the needs of the immediate customers of the group. Take action to implement a model of resourcing that assures sustainability and consistency of the group’s activity and output.
• Annual departmental goal setting & performance management (i.e. 1-1’s, mid-year assessments and year-end evaluations)
• Talent Management: development of talent from entry level to lead positions
• Personnel Development: individual development plans centered on behavioral/leadership competencies as well as the development of new skills and understanding for new technologies
• Establishing & maintaining employee/team engagement
• Build a strong working environment that promotes Emergent’s core values and progresses our culture in a positive manner
• Ensure that the MSAT group members work safely at all times. Stay current with, and apply, all good work safety practices adopted at the Canton site.
• 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
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
• B.S., M.S. or Ph.D. in a scientific or engineering (chemical/biochemical/bioprocess engg) discipline and 10+ years of industry experience
• Experience in managing scientists/engineers in a fast paced challenging environment
• Familiarity with site strategic planning (i.e. Hoshin)
• Hands-on industrial experience with cell culture, virus culture, harvesting and other upstream and downstream unit operations
• Experience in gene therapy or viral vector manufacturing is a plus
• Extensive working knowledge of cGMP systems and FDA/EU regulations
• Extensive experience in leading product/process support within a GMP manufacturing setting, leading complex troubleshooting investigations, technology transfer, process development, process monitoring, and process validation.
• Familiarity with project management skills, including strategic and tactical projects/tasks, tracking, and adhering to budgets, reporting project and campaign metrics
• Team player and exhibit a willingness to meet project timelines and be a “working manager”
• Strong verbal and written communication skills are required as well as effective interpersonal and influencing skills
• Outstanding planning, organization, and multitasking skills
• Quality System experience (i.e. Deviations, CAPA, Change Control)
• Key Skills / Competencies
o Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability
o Driving workforce engagement, Building effective teams
o Coaching/teaching/mentoring – modeling the desire behaviors/competencies within and across functions
o Managing conflict/conflict resolution
o Building trust and rapport with the workforce
o Promoting a healthy work environment (i.e. safe, empowered, learning oriented, focused on continuous improvement), Ensuring accountability (Behaviors, Performance, etc.)
IV: Physical/Mental Requirements
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 25lbs, and pull 25lbs. Use phone, copier, computer, copier, and hand tools. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem-solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Work around noise above conversation level, in hot/cold temperatures, where ventilation is needed, in multiple locations, and with restricted access to laboratory.
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.