Sr. Manager, Drug Substance Operations

Location
Gaithersburg, MD, US
Posted
Oct 30, 2020
Ref
679722000
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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.

JOB SUMMARY

Support the management of the Upstream and Downstream Operations units engaged in BioSciences projects in all stages of development. The activities include staff supervision, process design, technology transfer, and production of biologics drug supplies.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Supervise and lead team of process development personnel for the development and optimization of novel, scalable, and robust processes for therapeutic proteins
• Devise and implement process development and scale-up strategies using modern techniques and in relation to a product's phase of development
• Be a key member of DS Development and participate in the planning of timelines, deliverables, and milestones in close collaboration with other groups of Development Services in the CDMO Business Unit
• Ensure technology transfer of developed processes to internal or external Contract Manufacturing Organizations (CMO) for GMP clinical manufacturing
• Report on planning and progress of activities to Senior Management
• Manage employee performance and mentor staff on scientific innovation, regulatory guidelines, and project management

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.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Master's in a scientific discipline (Chemical or Biochemical Engineering, Biochemistry, or related field) with a minimum of 10 years of experience; Ph.D. and B.S. candidates will be considered based on equivalent experience
• Expert knowledge of scientific principles and concepts in cell culture, purification, or both, of protein therapeutics
• Behaviors and attitudes in compliance with Emergent's policies and culture, attributes of a mature leader and supervisor, and professional ethical standards
• Experience with the direct management and mentoring of personnel and excellent communication skills to interact with all levels of the organization
• Reputation as emerging leader in a biologics PD field (cell culture, purification, or both) with sustained performance and accomplishment
• Expertise in intermediate- to large-scale process development, technology transfer, and pilot or industrial scale-up, including specific experience with recombinant therapeutic proteins by mammalian and microbial cultures
• Expert ability to address problems that are highly varied, complex and often non-recurring, solved by novel and creative solutions
• Expert ability to operate process development equipment
• Excellent knowledge of cGMPs and regulatory requirements for therapeutic biologics in order to facilitate effective technology transfer of processes

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.

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