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.
The Sr. Manager, MSATwithin 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.
- 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.
- Manage process development, scale-up and process optimization activities, for example:
- 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.
- Lead complex troubleshooting investigations and drive process improvement initiatives.
- Write process development reports, engineering test protocols, simulation study reports including check list for equipment, process, materials, components, among others.
- Lab equipment qualification & reference standards calibration completed by responsible department
- Ensure process studies are written, executed and documented in professional reports
- Ensure that key procedures are properly established (including initiation of HSE reviews udits /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)
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.ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES
- Stand shoulder to shoulder no matter what
- We combine our best thinking and communicate openly to support each other.
- Break through thinking
- We take smart risks, pursue innovation and challenge ourselves to constantly improve.
- Own it always
- Every person at Emergent is engaged and accountable for delivering on our commitments.
- Compete where it counts
- We set the right goals and respect each other as we conquer them together.