Manufacturing Manager - Rockville, MD | Biospace
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Manufacturing Manager

Sanaria Inc.

Location:
Rockville, MD
Posted Date:
7/18/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Manufacturing, Manufacturing/Production,

Job Description


Sanaria Inc., a Rockville, MD based biotechnology company, is seeking a Manufacturing Manager for a unique and challenging opportunity for a world-class team working on the development and commercial manufacturing of a live sporozoite-based malaria vaccine that provides effective long-term immunity and lays the groundwork for eradication of malaria in areas where it is endemic.

Sanaria’s vaccine production is based on the life cycle of the parasite. Sanaria is producing material intended for Phase 3 trials and launch. Sanaria’s manufacturing is a team-based environment.

The Manufacturing Manager will be working closely with individual manufacturing teams along with Quality and Operations to achieve Sanaria’s manufacturing goals. The Manufacturing Manager will be responsible for the daily operations of Sanaria vaccine production reporting to the Executive Vice President of Process Development and Manufacturing.

Knowledge of aseptic operations and support systems is essential. A strong working knowledge of the regulatory compliance requirements for the production of biologics used in clinical studies and commercial manufacturing are essential. Demonstrated managerial skills, written and communication capabilities, and inter personal skills is necessary. The Manufacturing Manager must remain current regarding technical manufacturing requirements and must be able to develop/modifies production methods to fully address such issues. The Manufacturing Manager prepares validation protocols, SOPs, and master batch records. The Manufacturing Manager manages manufacturing operations assuring compliance with appropriate regulatory standards including but not limited to the Code of Federal Regulations (CFR), EMA Regulations, aseptic manufacturing, and/or Guidance documents such as U.S. FDA Points to Consider (PTC).

The Manufacturing Manager’s responsibilities are:

1.   Day-to-day activities of the manufacturing with respect to scheduling of production, operations and materials management activities.
2.   Investigate and resolve problems.
3.   Identify and implement process improvements.
4.   Responsible for managing the training and development of personnel.
5.   Responsible for interfacing and relationship development with all support departments (QC, QA, Facilities, Development, etc.) to assure production goals are met.
6.   Tracking and trending critical process parameters and critical quality parameters.
7.   Working with process development to review new process equipment compliance to   GMP regulations and aseptic process requirements.

Requirements


Education

BS/BA degree required in biological sciences, biotechnology or life sciences. Masters in biological sciences preferred.

Experience

3 to 5 years of work experience in pilot or commercial biologics manufacturing plant under cGMP requirements. 2 to 3 years prior management experience.

To apply, send cover letter, resume and salary requirement, subject line Manufacturing Manager.  Sanaria is an equal opportunity employer.  Work authorization without visa sponsorship is required.