Senior Director, R&D - BioProcess Engineering

Job Description
Job Description Major Duties and Responsibilities
The BioProcess Engineering (BPE) department, a part of the Biopharmaceutical Development organization (BD, R&D) is responsible for scale-up and technology transfer of drug substance manufacturing processes for all of MedImmune's protein products. The scale-up capability includes up to 500L of cell culture bioreactor scale, and 100L microbial fermenter scale. The scope of technology transfer encompasses both clinical (from three different sites, into the clinical manufacturing facility at 2000L scale), and commercial (to MedImmune's commercial manufacturing facility at 15,000L scale; or to a contract manufacturing facility); as well as both mammalian and microbial products.

The Senior Director of BPE will be responsible for creating and executing a compelling vision / strategy leading for this department of about 40 scientists / engineers and comprising of three groups -- cell culture engineering, purification engineering, and the development scale-up center. The leader of this department will be charged with ensuring the scalability and manufacturability of processes, while enhancing future capabilities to advance MedImmune's growing late-stage pipeline.


-He/She will continue strong collaboration with other organizations including commercial MS&T (Manufacturing Sciences & Technology), Quality, process /analytical / formulation development

-Lead directors/associate directors who supervise a team of staff across two local sites

-Provide feedback to design groups on experience gained from process implementation

-Work closely with Cell Culture and Purification development groups creating a team environment for scale-up operations, testing of new equipment, technologies and processes, as well as optimization of procedures

-Represent Biopharmaceutical Development on strategic initiatives.

-Think strategically about various technical and scientific opportunities, as well as broader scientific initiatives such as QbD

-Develop, implement, and monitor monthly and yearly goals for the function. Create multi-year goals for the team to enable corporate long-term objectives.

-Discuss and offer solutions for scale-up / operability problems with colleagues and senior personnel.

-Create and execute competitive and breakthrough strategies and plans.

Position Requirements Position:
MS with about 20 years of biotechnology industrial experience, or Ph.D with about 15 years experience is required. Knowledge of large scale GMP clinical or commercial manufacturing is a plus. Minimum 5 years of direct supervisory experience in a laboratory, mammalian or microbial manufacturing facility. Working knowledge of cell culture, protein purification, data analysis, modeling, technology transfer, and cGMP required with in-depth experience in either cell culture or purification.

Requires an MS, or PhD in Chemical/Biochemical Engineering (or other relevant discipline) with relevant industrial experience in process development / manufacturing support, related to bioprocessing for therapeutic protein products.
Additional Notes The ideal candidate will have prior experience hiring and building a functional team. Should be able to generate periodic updates and prepare formal presentations for required forums, serve on or lead teams/committees including development (CMC) teams, and provide leadership to his/her group, with a focus on verbal and written communication, teamwork and problem solving.

Job Complexity
The job is highly complex, requiring an understanding of cell culture/fermentation and/or purification/formulation operations, manufacturing, and personnel management. This job requires interactions across functional and departmental lines as well as the ability to represent the BioProcess Engineering function and at times the entire Biopharmaceutical Development organization. The ideal candidate will engage in / lead complex problem solving efforts that span corporate and functional objectives. Erroneous decisions or recommendations would result in critical delays and modifications to projects or operations; cause substantial expenditure of time, human resources, and funds; and jeopardize future business activity.

Will supervise directly or indirectly multiple scientists/engineers through directors/associate directors with BS/MS/PhD degrees in scientific or engineering fields or equivalent industry experience. Responsible for annual performance evaluations and career guidance for subordinates. Will act as mentor for supervisory personnel and will actively work to develop subordinates within the organization.
Req ID 6091
Position Category Development - Bioprocess Engineering



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