Sr Manager, Pilot Plant & MSAT
Canton, MA, US, 02021 Canton, MA, US, 02021
We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
JOB SUMMARY
The MSAT Sr. Manager within the Manufacturing Sciences & Technology department is responsible for leading a team of MSAT associates, scientists and engineers engaged in projects in the pilot plant. The complexity of the work demands a solid technical background across a variety of scientific disciplines which includes manufacturing process technologies, biopharmaceutical best practices, cell culture, virus culture, various unit operations, statistical analysis, technical report writing among others.
More specifically, this role leads the activities for process development in the pilot lab and process transfer to manufacturing area. This manager works closely with technical/management representatives from other functions at Canton site.
Strong people leadership and communication skills are essential for the leader of this team. This position includes leading a team comprised of engineers and/or 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.
ESSENTIAL FUNCTIONS
Business
• Participate on MS&T Leadership Team to ensure appropriate alignment of resources to technical challenges and routine operational needs
• Take responsibility for running the pilot plant operations in satisfactory condition. Periodically publish the activities calendar for the pilot plant with appropriate resource allocation
• Maintain good working relationships with internal and external partners/customers (Manufacturing, QC, QA, Eng., etc.)
• Ensure projects in the pilot plant are run on time, in budget and resource constraints are addressed
Technical
• Manage 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 including check list for equipment, process, materials, components, among others
o Lab equipment qualification & reference standards calibration completed by responsible department
o Ensure process studies are written, executed and documented in professional reports
o Ensure that key procedures are properly established (including initiation of HSE reviews /audits /requirements where necessary)
• Support existing business processes such as review of MFG SOP/FRM/BPR document revisions, deviations, CAPAs, CCRs
• Review department monthly logbook and coordination for monthly QA review of logbooks,
• Allocate pilot plant resources to projects consistent with MSAT strategy and site goals, publish updates to monthly calendar and communicate activities to site communications
• Order materials for pilot plant operations in coordination with Supply Chain
People Management/Employee Development
• Builds a strong working environment that promotes our core values and progresses our culture in a positive manner
• 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 (utilizing SLII concepts) 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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• A degree (Bachelor to Ph.D.) in a science or engineering (chemical/biochemical/bioprocess engineering) 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
• 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/MiniTab or equivalent 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.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
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.
Nearest Major Market: Boston